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BHI Weekly News Archives

441st Edition, February 2, 2021

By BHI Weekly News Archives




BioHealth Innovation


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February 2, 2021












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Viela Bio to be acquired by Horizon Therapeutics for $3.1 billion – Washington Business Journal

The move comes less than three years after the Gaithersburg biotech spun out of MedImmune.

Image: Viela Bio CEO Bing Yao, pictured here on the company’s IPO day at the Nasdaq. LIBBY GREENE

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Emergent BioSolutions unveils 7th pandemic CDMO contract, this time for Humanigen’s late-stage antibody hopeful | FiercePharma

Manufacturing powerhouse Emergent BioSolutions unveiled its seventh COVID-19 CDMO tie-up Monday, this time to help crank out Humanigen’s late-stage antibody hopeful lenzilumab.

Emergent will hustle along fill-finish work on lenzilumab at its Camden plant in Baltimore, boosting supplies ahead of a possible emergency nod early this year. Humanigen’s monoclonal antibody, designed to treat and prevent the immune hyper-response known as cytokine storm, is currently in a phase 3 trial in hospitalized patients, and the company says it expects to file for an emergency use authorization in 2021’s first quarter.

Image: Emergent recently completed a new filling line at its Camden plant in Baltimore, pictured above. (Emergent BioSolutions)

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On Demand Pharmaceuticals picks Rockville for new HQ – Washington Business Journal

The move solidifies the company’s local presence about four months after it secured a temporary occupancy permit in September.

Image: Ben Wu is CEO of the Montgomery County Economic Development Corp. EMAN MOHAMMED

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Novavax Reports Varying Success vs. COVID-19 Variants

Novavax electrified investors last night by announcing that its COVID-19 vaccine NVX-CoV2373 showed efficacy of 89.3% in the company’s first analysis of data from a Phase III trial in the U.K., where a variant strain (B.1.1.7) accounted for about half of all positive cases.

However, NVX-CoV2373 achieved only 60% efficacy in a Phase IIb trial in South Africa, where that country’s escape variant of the virus (B.1.351, also known as 20H/501Y.V2) was seen in 90% of cases, Novavax said.

“NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging U.K. and South Africa variants,” Stanley C. Erck, Novavax’s president and CEO, said in a statement.

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GetWellNetwork scoops up Docent Health | MobiHealthNews

Patient engagement platform GetWellNetwork announced it has acquired patient-messaging company Docent Health for an undisclosed sum.

As part of the deal, GetWellNetwork will be able to offer Docent Health’s tool as a combined offering with its other services. The messaging service uses artificial intelligence to message patients about their care. Additionally, its platform is able to collect patient data and, in turn, triage patients and find them the right place of care to seek.

Image: https://www.mobihealthnews.com

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European Medicines Agency recommends conditional marketing authorisation to ChAdOx1 coronavirus vaccine – Vaccitech

Oxford, UK – Vaccitech Ltd announces that the European Medicines Agency (EMA) has today recommended the conditional marketing authorisation of the ChAdOx1 nCoV-19 coronavirus vaccine developed by the University of Oxford with its partner AstraZeneca. Distribution will begin across all 27 member states once the decision is ratified by the European Commission. The vaccine was co-invented by Vaccitech and The University of Oxford’s Jenner Institute.

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Biden White House Strikes $230M Deal for At-Home Coronavirus Testing Kits | Health News | US News

THE BIDEN administration announced Monday that it is investing $230 million in Ellume, an Australian company, for millions of its at-home coronavirus testing kits.

The deal, struck by the Department of Health and Human Services and the Department of Defense, ensures 100,000 over-the-counter test kits will arrive in the U.S. starting this month through July, acting Centers of Medicare and Medicaid Services Administrator Andy Slavitt said Monday during a White House briefing.

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Engenious Selected For Development Of New NTrainer System®

Medical device engineering firm, Engenious Design, partners with Innara Health to design the 2nd generation of their ground-breaking technology designed to improve feeding outcomes in premature infants. Prairie Village, KS: Engenious Design, a 39-person creative product development firm specializing in electronic medical device design, has partnered with Kansas City-based start-up Innara Health to develop Innara’s next-generation NTrainer System ®, designed to improve access to more patients by reducing the size and cost of the system, enabling Innara to expand into new markets and provide better access to life-changing therapy and assessment tools for infants.

 

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RIC welcomes Rare Disease Institute as first occupant | Children’s National

The Children’s National Research & Innovation Campus (RIC), the first-of-its-kind pediatric research and innovation hub located in Washington, D.C., now has its first occupant – the Rare Disease Institute (RDI).

The institute, which includes the largest clinical group of pediatric geneticists in the nation, focuses on developing the clinical care field of the more than 8,000 rare diseases currently recognized and advancing the best possible treatments for children with these diseases.

Image: https://innovationdistrict.childrensnational.org/

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$125M pharmaceutical plant to be built in Petersburg will create 200 jobs – Richmond BizSense

Two young pharmaceutical companies are teaming up to bring a sizable new facility and nearly 200 new jobs to Petersburg.

Gov. Ralph Northam announced Thursday that Civica Inc., a Utah-based drug manufacturing nonprofit, will build a $124.5 million pharmaceutical plant along North Normandy Drive in Petersburg.

Image: The proposed $125 million pharmaceutical plant in Petersburg will total 120,000 square feet. (Courtesy of Phlow)

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LifeBridge Health, Healthworx launch innovation incubator for health tech startups

Baltimore-based LifeBridge Health is partnering with Healthworx, the innovation and investment arm of CareFirst BlueCross BlueShield, to launch a new incubator for startup companies developing healthcare technologies and innovations.

The incubator, dubbed 1501 Health, will provide companies participating in the program up to $100,000 in investment as well as access to mentorship and support from payer and provider experts, according to a Jan. 26 news release emailed to Becker’s Hospital Review.

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Wilmington digital health company Amalgam Rx acquired Avhana Health – Technical.ly Delaware

Wilmington’s Amalgam Rx, a digital medicine and patient support company, has acquired Baltimore-based Avhana Health.

With the acquisition, which closed this month, Avhana’s seven employees will join Amalgam’s 100-member team, which already has a presence in Baltimore. The acquisition is Amalgam Rx’s first. Terms were not disclosed.

Image: (Image via linkedin.com/company/amalgamrx)

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Baltimore’s Catalio partners with New York investment firm HealthCor Management to launch blank check IPO – Baltimore Business Journal

A new “blank check” company created through a partnership between Baltimore venture capital firm Catalio Capital Management and New York investment firm HealthCor Management launched a $180 million IPO Wednesday.

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It’s not too soon to start thinking about the next pandemic | LinkedIn

One of the questions I get asked the most is when I think the world will get back to normal. I understand why. We all want to return to the way things were before COVID-19. But there’s one area where I hope we never go back: our complacency about pandemics.

The unfortunate reality is that COVID-19 might not be the last pandemic. We don’t know when the next one will strike, or whether it will be a flu, a coronavirus, or some new disease we’ve never seen before. But what we do know is that we can’t afford to be caught flat-footed again. The threat of the next pandemic will always be hanging over our heads—unless the world takes steps to prevent it.

Image: https://www.linkedin.com/pulse/its-too-soon-start-thinking-next-pandemic-bill-gates/

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Emergent BioSolutions to make J&J COVID-19 vaccine in Baltimore

The Johnson & Johnson one-shot coronavirus vaccine is expected to be a game-changer in fighting COVID-19 — and it will be made in Baltimore.

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Six Biotechs to Watch in 2021 – BioBuzz

2020 was an interesting year for the biotech industry and the BioHealth Capital Region as we adjusted to continue moving forward during the COVID-19 Pandemic. While the biggest stories in terms of dollars were related to the Coronavirus and funding to create a vaccine in record time, that didn’t stop other biotech companies from working hard to develop their research, science, and/or devices.

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Task Force Recommends Regional Hydrogen Center; Discusses Delivery of Strategic Initiatives

WASHINGTON, D.C., January 29, 2021 – Connected DMV’s COVID-19 Strategic Renewal Task Force held its seventh meeting on Thursday, adopting a recommendation to proactively address climate change through the establishment of a regional Hydrogen Center that affirms Greater Washington as a leader in the hydrogen economy. Task Force members agreed that collaboration across borders and disciplines to tackle climate change, using hydrogen energy, is a national and regional imperative, and by utilizing the significant assets of the DMV region, an achievable goal.

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The Apollo Program for Biodefense – Winning the Race Against Biological Threats – Bipartisan Commission on Biodefense

The COVID-19 pandemic is a stark wake-up call for the United States to take biological threats seriously. The virus is on track to take the lives of more than 400,000 Americans and cost our economy trillions of dollars. The risks of future pandemics increase as technological progress eases barriers to modifying pathogens, raising the specter of novel biological agents causing diseases much worse than humanity has ever faced. Meanwhile, U.S. vulnerabilities to biological attacks have never been clearer to our adversaries.

However, there is a path forward. The Apollo Program for Biodefense would provide the United States the opportunity to mobilize the nation and lead the world to meet these challenges: a world where we detect and continually trace any new pathogen from the source; where we can distribute rapid point-of-person tests to every household in the country within days of that detection; where effective treatments are already in-hand; where vaccine development and rollout occur in weeks rather than years; and where pandemics will never again threaten the lives and livelihoods of Americans and people around the world.

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Meet the 9 ventures in Halcyon’s latest incubator program this spring – Technical.ly DC

Georgetown-based Halcyon Incubator has announced the 14th cohort for its incubator for early-stage social impact entrepreneurs. The 18-month fellowship welcomes nine ventures, majority of which are minority-owned, to scale their business models.

Image: Halcyon House in Georgetown. (Photo via Halcyon on Facebook)

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Workers Producing the Vaccine Need Vaccination – WSJ

In the race to vaccinate people for Covid-19, everyone agrees front-line health workers, the elderly and those with pre-existing conditions should get priority. But one vital group is being overlooked. Even worse, some are criticizing efforts to vaccinate them as some sort of effort to “cut the line.”

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Here are some of the fascinating predictions from Kurt Newman

Recently a colleague asked me to predict the future of pediatric #medicine in 30 years. To help develop my list, I tapped many of the smartest people I know: Leaders from Children’s National Hospital. Here are some of the fascinating predictions.

1) Healing children and keeping them healthy will be an international priority, which is reflected in increased attention and funding for pediatric medicine and #research.

 

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New Johns Hopkins report details plan for digital equity in Baltimore | Hub

The lack of reliable access to broadband internet service for many in Baltimore, particularly the poor, has profound economic and social consequences. The COVID-19 pandemic has made this painfully clear with its abrupt shifts to online learning, remote work, and telemedicine. A new analysis from Johns Hopkins University’s 21st Century Cities Initiative says the city could move towards digital equity, with a roadmap of recommendations built on existing knowledge of Baltimore’s digital assets and the experiences of other cities.

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Healthworx and LifeBridge Health Launch Startup Incubator: 1501 Health

Newswise — Healthworx, the innovation and investment arm of CareFirst BlueCross BlueShieldis partnering with LifeBridge Health to launch 1501 Health, an incubator for healthcare startups. 1501 Health will provide investment and resources to help early-stage companies, located regionally or nationally, develop their healthcare solutions.

Companies participating in the program will receive up to $100,000 in investment and have access to unique mentorship and support from payer and provider experts, along with networking and educational events with other startups, investors and stakeholders.

Image: Healthworx 1501 Health in Baltimore, MD

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Pharma Giant Roche Partners for Quantum Drug Discovery

Earlier this month we posited the idea that 2021 could be the year of quantum computing-led drug discovery and predicted that partnerships like those of Google and European pharma giant Boehringer Ingelheim would be more common with more quantum hardware makers tying the knot with drug manufacturers.

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Copyright © BioHealth Innovation 2020
All Rights Reserved.



440th Edition, January 26, 2021

By BHI Weekly News Archives




BioHealth Innovation


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January 26, 2021












FOUNDING MEMBER OF



New “Virginia Bio-Connect” Statewide Consortium and Scale-Up Initiative Featured on BioTalk

Amy Adams with George Mason University. Nikki Hastings with CvilleBioHub, and John Newby with Virginia Bio join Rich Bendis to discuss the new “Virginia Bio-Connect” statewide consortium and scale-Up initiative.

Listen now via Apple http://apple.co/39ZDl0M, Google http://bit.ly/3iRzmHO, Spotify https://spoti.fi/2MqHTVJ, and TuneIn http://bit.ly/2Yelr58. #innovation #biotalk #university #healthcare #digitalhealth #healthtech #research #biotech

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EIR Feedback (BHI) (Only Two Slots Left!)

Wednesday, January 27, 2021

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

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Nonprofit eyes Montgomery County for global pandemic prevention center

A nonprofit is considering Montgomery County as the site of a global pandemic center that would focus on prevention, research and response.

The Global Pandemic Prevention and Biodefense Center would serve as the “world’s epicenter” for pandemic prevention and biodefense ecosystem coordination.

County Council Member Hans Riemer proposed a $500,000 special appropriation to help fund the strategy phase of the project, which began in December. The appropriation was introduced at the council’s meeting on Tuesday.

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Gaithersburg biotech NexImmune files for IPO – Washington Business Journal

The company, which is developing cancer treatments, plans to trade on the Nasdaq Global Market.

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Germantown’s Precigen Announces Pricing of $112.5 Million Public Offering of Common Stock – BioBuzz

GERMANTOWN, Md., Jan. 22, 2021 /PRNewswire/ — Precigen, Inc. (Nasdaq: PGEN) today announced the pricing of an underwritten public offering of 15,000,000 shares of its common stock at a public offering price of $7.50 per share. Precigen has also granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of its common stock. Gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $112.5 million, excluding any exercise of the underwriters’ option. The offering is expected to close on January 26, 2021, subject to customary closing conditions.

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COVID-19 Vaccine Handling Toolkit

Recent challenges around preparing, transporting, and administering COVID-19 vaccines have received national and international attention. As part of our ongoing COVID-19 response, the U.S Pharmacopeia (USP) rapidly engaged stakeholders and convened experts to identify and help address operational efficiency gaps to help increase COVID-19 vaccinations.

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Money Moves: Bethesda healthtech biz Aledade closed a $100M Series D – Technical.ly DC

Bethesda, Maryland-based Aledade, manager of a tech platform to help healthcare providers join forces to reduce Medicare costs, closed a $100 million Series D funding round. This latest investment round was led by returning investor Meritech Capital.

The tech company plans to use the fresh funding to expand its value-based care model and secure more strategic partnerships with Medicare Advantage (MA) plans to benefit seniors. Through MA contracts, the company serves more than 100,000 patients, per a news release.

Image: The Aledade team. (Photo via @AledadeACO on Twitter)

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Cerecor Announces Proceeds from Option to Purchase Additional Shares of Common Stock Bringing Public Offering Proceeds to $40.7 Million :: Cerecor, Inc. (CERC)

ROCKVILLE, Md. and CHESTERBROOK, Pa., Jan. 20, 2021 (GLOBE NEWSWIRE) — Cerecor Inc. (“Cerecor”; NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, announced today the exercise by the underwriters of their option to purchase an additional 1,648,812 shares of Cerecor’s common stock, $0.001 par value (the “Common Stock”) at a price to the public of $2.60 per share, increasing the total offered through the previously announced underwritten public offering to 13,971,819 of Common Stock and 1,676,923 of prefunded warrants. The gross proceeds to Cerecor from this exercise were approximately $4.3 million, resulting in approximately $40.7 million total gross proceeds from the offering. Cerecor intends to use the proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses.

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Rockville contract research organization Emmes creates biopharma and public health business units, acquires Neox – Washington Business Journal

In the last four months, this Rockville life sciences services firm has gotten a new CEO, purchased a company and split the business in two to brace for more growth.

Image: Dr. Christine Dingivan took over as president and CEO of Rockville contract research organization Emmes at the end of September. COURTESY EMMES

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Alexandria Launch Labs

Alexandria LaunchLabs™ in Maryland, will provide fully equipped, affordable laboratory/office space with flexible lease terms, supporting infrastructure, access to amenities, and supporting services and programming through the project’s consortium of world-class partners, including Alexandria Venture Investments, BioHealth Innovation, Montgomery County, and the City of Gaithersburg. This unique, startup environment will accelerate the growth of local early-stage life science companies.

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QIAGEN confirms effectiveness of its SARS-CoV-2 PCR tests in the face of mutations of the coronavirus

Germantown, Maryland, and Hilden, Germany, January 20, 2021 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced its polymerase chain reaction (PCR) tests remain accurate and effective in detecting SARS-CoV-2 infections – and will continue to closely monitor their performance as global concerns mount regarding the detection of new viral variants by established testing methods.

QIAGEN has successfully assessed its SARS-CoV-2 PCR tests against genetic mutations of the virus uploaded to the GISAID and GenBank public databases since May 2020. A latest round of assessments conducted in January 2021 again confirmed that no recorded mutations affected the sensitivity of QIAGEN assays for detection of SARS-CoV-2. Surveillance of genetic variations will continue on a biweekly basis.

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Veralox Therapeutics Announces FDA Orphan Drug Designation for VLX-1005

FREDERICK, MdJanuary 26, 2021 – Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for VLX-1005 for the treatment of heparin induced thrombocytopenia (HIT).

“We are pleased the FDA has granted Orphan Drug Designation for VLX-1005 for prophylaxis of thrombosis in patients with heparin-induced thrombocytopenia,” said Jeffrey W. Strovel, PhD., Chief Executive Officer of Veralox Therapeutics. “This is a significant regulatory milestone for our company, and in the development of this investigational new drug product and recognition of the clear unmet medical need for patients who suffer from this devastating disease.” “

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The World’s Top Ten Quantum Tech Universities and Research Institutions

University research labs are playing a central role in the development of quantum technologies, such as quantum computers and quantum communication devices. Universities often approach quantum science from a number of angles. Some are good at theoretical approaches to quantum science. Some are strong at applied quantum science. Some focus on the educational and outreach of quantum physics.

Image: Research labs, like this one at the University of Waterloo’s Institute for Quantum Computing, are the heart of the world’s growing quantum industry.

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Senseonics adds EmblemHealth to insurer list, initiates offering while facing FDA delays – Washington Business Journal

The moves come after an uncertain period for the Germantown biotech.

Image: Tim Goodnow is president and CEO of Germantown-based Senseonics. JOANNE S. LAWTON

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CCF FY2021 Solicitation

CIT is conducting a competitive solicitation for young Virginia companies that have strong potential to drive economic growth in Virginia, including revenue and job creation, in strategically important industry sectors. The CCF FY21 round will provide grants up to $100,000 to advance companies and their highly promising technologies that have seen traction, for instance through revenue and/or investment, and would be catalyzed by support to commercialize the technologies or access the market. Up to $7 million has been allocated for the single FY21 round. Projects are anticipated to be 6-12 months and CCF funding can supports companies’ commercialization goals through product or service development, pilots, intellectual property protection, marketing, and more.

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Black Innovators in Skin Health QuickFire Challenge – Challenge | JLABS

For too long, the face of skincare has reflected only SOME of the faces we see within our communities. We know there are a lack of consumer products available tailored to the needs of the Black community.

As the world’s largest healthcare company, Johnson & Johnson recognizes and embraces our responsibility for enacting change. Within our consumer business, our products must reach, have a positive impact on, and most importantly, serve everyone. Looking to the future of healthcare, we must seek out and support innovators from diverse backgrounds in order to generate inclusive solutions.

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Science Takes Center Stage in the Biden Administration

The number of changes being implemented by the new administration in the White House are likely too many to count. And while many are significant, one strikes a chord with the scientific community in a very meaningful way. In the days leading up to his inauguration, President Biden made it clear that science is a priority. He has backed that up with several recent announcements.

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STEM Talent Challenge Awardees Announced

EDA is pleased to announce today that seven organizations from across the United States have been awarded a total of $2 million in grants through the inaugural STEM Talent Challenge, which aims to boost local science, technology, engineering, and math (STEM) talent.

Grant projects are building STEM workforce readiness while fueling innovation and entrepreneurship in emerging and transformative sectors, such as space commerce, aeronautics, digital manufacturing, biotechnology, advanced manufacturing, and cybersecurity. Click here for more about each project.

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Home | About BHI | BHI News | Programs | Partners | Contact

Copyright © BioHealth Innovation 2020
All Rights Reserved.



439th Edition, January 20, 2021

By BHI Weekly News Archives




BioHealth Innovation


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January 20, 2021












FOUNDING MEMBER OF



United States Pharmacopeia CEO Ronald T. Piervincenzi, Ph.D. Joins Rich Bendis on the BioTalk Podcast

Ronald T. Piervincenzi, Ph.D., Chief Executive Officer, United States Pharmacopeia virtually sits down with Rich Bendis to discuss the over 200 year old Organization, the services they offer, and their goals for the future.

Listen now on Google http://bit.ly/2NjX8As, Apple http://apple.co/3irukRQ, Spotify http://spoti.fi/35UfM8B, and TuneIn http://bit.ly/2XRFEgD.

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Amalgam Rx Announces Acquisition of Avhana Health (BHI client acquired participant in our Dreamit Health Accelerator)

Amalgam Rx, Inc., a leading Digital Therapeutics and Patient Support company, announces the acquisition of Avhana Health, a privately held clinical decision support (CDS) company, which has deep integrations with the leading electronic health records (EHR). Amalgam Rx will expand Avhana’s CDS tools to multiple therapeutic areas and combine them with other digital solutions to simplify doctors’ workflows.

Avhana Health is a CDS company used by doctors to support real-time adoption of and adherence to clinical quality guidelines. Avhana’s SaaS-based CDS tool has been implemented in more than 150 provider groups and identifies over $120 million a year in cost savings. Enabling real-time two-way interactions within the EHR, Avhana optimizes provider workflow beyond simple data integration.

 

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Immunomic Therapeutics raises another $16M for cancer programs – Washington Business Journal

The latest funding comes on top of $61.3 million in new funding the local biotech raised in April.

Image: Bill Hearl is CEO and founder of Immunomic Therapeutics in Rockville. COURTESY IMMUNOMIC THERAPEUTICS

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EIR Feedback (BHI)

Wednesday, January 27, 2021

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

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Inventions Boosting Health in the Developing World | The Borgen Project

More often than not, girls in developing countries either cannot afford or do not have access to menstrual products. This makes it extremely difficult for them to go about their day, particularly if they are in school. Flo is a menstrual product that allows the user to wash, dry and carry a reusable menstrual pad with dignity. The concept was developed by Mariko Higaki Iwai. The Flo menstrual kit was designed with the following issues in mind:

 

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Immunotherapy Veteran Robert Knight, MD, Joins NexImmune as Chief Medical Officer

GAITHERSBURG, MD – January 18, 2021 – NexImmune today announced the appointment of Dr. Robert (Bob) Knight as Chief Medical Officer (CMO). Dr. Knight is a seasoned executive with extensive experience leading early- and late-stage immunotherapy product development teams. Prior to joining NexImmune, Dr. Knight led the Yescarta® clinical program at Kite Pharmaceuticals (a Gilead Company) and, prior to that, spent 16 years at Celgene Corporation as a Vice President in Clinical Research. During his tenure at Celgene, he helped lead the development of the company’s IMiD and targeted therapy programs, including thalidomide, lenalidomide, and enasidenib. In addition to his roles at Kite and Celgene, Dr. Knight also led the cancer immunotherapy development program at Sorrento Therapeutics as the company’s Senior Vice President and Head of Clinical Research.

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Md. Department of Commerce eyes changes to to tax credit programs – Baltimore Business Journal

After a bitter battle with Democratic lawmakers last year, the Department of Commerce is looking to alter the biotech, cybersecurity and research and development tax credits.

Image: Maryland Commerce Secretary Kelly Schulz wants the legislature to pass four bills that would alter tax credit programs including the cybersecurity and biotechnology tax credits. ERIC STOCKLIN

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NexImmune Appoints Healthcare Innovator Grant Verstandig as New Board Member

GAITHERSBURG, MD – January 19, 2021 – NexImmune, a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response that mimics natural biology, today announced the appointment of Grant Verstandig to its Board of Directors.

“We are delighted to welcome Grant to the NexImmune Board,” said Sol Barer, PhD, Chairman of NexImmune’s Board of Directors. “Grant is a recognized innovator and leader in the evolving fields of digital health and artificial intelligence (AI). We believe that better understanding the intersections of biology, big data and artificial intelligence is a clear trend in our industry and will greatly help the Company design, implement and collect outcomes on clinical trials that may truly transform the way we develop novel therapeutics. We look forward to working with him as we continue the development of our product candidates and technology platform.”

 

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Novavax taps Baxter for commercial production as COVID-19 vaccine nears finish line – BioBuzz

With a phase 3 data readout on its COVID-19 vaccine looming, Novavax has already started stockpiling doses ahead of an authorization. Now, thanks to a fresh manufacturing tie-up, the company’s ex-U.S. supplies just got a little more secure.

Novavax tapped Baxter BioPharma Solutions to handle commercial-scale vaccine manufacturing at its facility in Halle, Germany. Once production work kicks off, Baxter will be on deck to crank out supplies for the European and U.K. markets, the companies said.

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United Therapeutics Announces New England Journal of Medicine Publication of the INCREASE Study Evaluating Tyvaso® in Pulmonary Hypertension Associated with Interstitial Lung Disease

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Jan. 13, 2021 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced that results from the INCREASE clinical study of Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) have been published online in the New England Journal of Medicine. Results from INCREASE, the largest and most comprehensive completed study of adult patients with PH-ILD, showed that treatment with inhaled Tyvaso was well tolerated and improved the exercise capacity measure of six-minute walk distance (6MWD) by 31 meters relative to placebo at Week 16 (p

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If You Bought Alexandria Real Estate Equities In 2001, Are You Smiling? – My Morning Joe Stock Watch

A key lesson we can learn from Warren Buffett, is about how to think about a potential stock investment in the context of a long-term time horizon. Every investor in a stock has a choice: bite our fingernails over the short-term ups and downs that are inevitable with the stock market, or, zero in on stocks we are comfortable to simply buy and hold for the long haul — maybe even a twenty year holding period. Heck, investors can even choose to completely ignore the stock market’s short-run quotations and instead go into their initial investment planning to hold on for years and years regardless of the fluctuations in price that might occur next.

Image: Photo credit: commons.wikimedia.org

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Tips for Life Science Job Seekers Heading Into 2021 – BioBuzz

The pandemic changed everything. We live differently, behave differently, and have come to appreciate the little things we might have taken for granted before COVID-19 took hold in the BioHealth Capital Region (BHCR).

We saw a move to nearly 100% remote work within the life sciences industry, companies pivoting to join the fight against SARS-CoV-2, and telemedicine finally earning more widespread acceptance and usage. The region became an epicenter for COVID-19 vaccine development and funding, requiring a host of companies to recruit and hire new talent to support the fight against the pandemic while also advancing their own pipelines.

Image: https://biobuzz.io

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WEBINAR: Reducing Barriers to Federal Partnerships

Join MCEDC and the FLC for a free virtual seminar. Learn about proposed policies for obtaining federal R&D funding, licensing federal technologies and accessing federal resources. The Department of Commerce has proposed new rules and legislation to provide extended protection for proprietary information, allow the licensing of government produced software, authorized more flexible grant terms – and more.

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In 2020, Maryland saw most VC funding dollars since 2001 – Technical.ly Baltimore

Venture capitalists invested $1.159 billion into Maryland companies, according to data from the MoneyTree Report by PwC/CB Insights. It marks the third-highest VC dollar total in a year since 2000, and the highest since 2001.

The funding was invested over 79 deals that included a pair of megadeals over $100 million, which typically drive yearly totals up.

“Maryland not only had a good year in 2020 but the upward trend in funding over the last 20 years in Maryland is quite encouraging as well,” said Brad Phillips, a director in PwC’s emerging company services practice.

Image: (Photo by Flickr user Austin Kirk, used under a Creative Commons license)

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Apply, Enroll & Explore Course Catalog

The Foundation for Advanced Education in the Sciences (FAES) at the NIH will host a Virtual Open House on Monday, March 1 for its online Spring 2021 Academic Programs, including the several courses for its “Advanced Studies in Technology Transfer Program”. The Advanced Studies in Technology Transfer is a low-cost, open enrollment program with class credits transferable into various university graduate degree programs. Online registration for these classes is now open:

Online Courses

  • TECH 514 | Technology Transfer: Transitions, Processes, and Players (Starts March 22)
  • TECH 540 | Introduction to Life Sciences Licensing (Starts March 22)
  • TECH 566 | Building a Biotech Company: Business Leadership and Management Strategies (Starts March 22)
  • TECH 582 | Intellectual Property and Patent Prosecution for Scientists (Starts March 22)
  • TECH 607 | Capstone Course in Technology Transfer (Starts February 1 and March 22)

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Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 | FDA

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” 

 

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Maryland companies raised highest amount of venture capital ever in 2020 – Baltimore Business Journal

Maryland’s growing companies raised a record $1.16 billion in VC dollars last year.

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United Therapeutics Sponsors Pulmonary Fibrosis Foundation Registry

The Pulmonary Fibrosis Foundation (PFF) announced that United Therapeutics will sponsor the PFF Registry.

The Registry is a research resource that tracks clinical data, samples, and patient-reported outcomes from people living with pulmonary fibrosis in the U.S.

According to the PFF, United Therapeutics’ sponsorship of the Registry will aid researchers who are working to develop better treatments for people with pulmonary fibrosis and secondary pulmonary hypertension (PH, when the blood pressure in the lungs is abnormally high).

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COVID-19 One Year Later: The Biology and the Business

The days are long, but the years are short.” This bittersweet saying, which is often shared with new parents, may apply to everyone who has been living through the COVID-19 pandemic—although what we’re experiencing is almost entirely bitter and not at all sweet. Over the past 12 months, SARS-CoV-2, an RNA virus that carries a mere 29,903 nucleotides, has devastated our communities, disabling economies and taking far too many lives. However, as we hit the grim one-year anniversary of COVID-19, we may anticipate a measure of relief.

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EY Firepower Report: Biopharma M&A Poised to Rebound in 2021

A significant volume of new M&A deals during 2021 are expected to involve cell and gene therapy developers as in recent years—but with an emerging twist resulting from some recent clinical disappointments for autologous treatments . . .

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HHS expands COVID-19 public health emergency until April, preserving key telehealth flexibilities | FierceHealthcare

The Department of Health and Human Services (HHS) has extended the public health emergency surrounding the COVID-19 pandemic until April, extending key waivers for regulations on a variety of topics such as telehealth.

The public health emergency declaration was originally scheduled to expire Jan. 21. HHS Secretary Alex Azar extended the emergency Thursday, according to a notice.

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15 Biggest Vaccine Companies in the World

In this article, we are going to list the 15 largest vaccine companies in the world. Click to skip ahead and jump to the 5 largest vaccine companies in the world. Vaccination is the most simple and effective way of prevention of many diseases. It provides immunity to infectious diseases and it is the most cost-effective method to protect the world population. The first-ever vaccine was introduced for smallpox to treat the deadly cowpox virus in 1796. This virus killed many people and developing a vaccine for it saved many lives. But the concept of vaccines existed even before 1796. Pharmaceutical companies around the globe have worked to develop vaccines for diseases such as Malaria, HIV, cholera, influenza and tuberculosis.

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Connect Media: CRE – Boston Commercial Real Estate News

Alexandria Real Estate Equities has announced it has entered into an agreement to purchase 401 Park Drive and 201 Brookline Ave. from Samuels & Associates for $1.5 billion. The office and research campus is located in Boston’s Fenway neighborhood and will include 1.8 million square feet of rentable space.

The 401 Park property was built in 1928 as a Sears, Roebuck and Co. distribution center and is home to a number of office and life science tenants. It is 93% occupied across 973,000 rentable square feet. The property is on the National Register of Historic Places and is also a retail and restaurant hub. The property at 201 Brookline is a 510,000-square-foot, 14-story office and lab development currently under construction with an estimated completion date of next year.

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Harvard, MIT and Boston-area hospitals get $76M for health innovation center

Harvard University and the Massachusetts Institute of Technology’s joint biological innovation center has secured $76 million and signed a lease for a new facility in Watertown, Mass., according to a Jan. 14 news release.

Harvard and MIT partnered with several Harvard-affiliated teaching hospitals including Massachusetts General and Brigham and Women’s in November 2019 to launch the Center for Advanced Biological Innovation and Manufacturing.

The new funding will go toward building the 40,000-square-foot facility and support 40 full-time employees. The center expects to begin operations in early 2022.

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BIA | US investors flock to UK biotech as sector delivers strong outperformance in a turbulent 2020

Biotech companies on London stock markets delivered market-beating returns in 2020 and attracted new investors looking for growth in a turbulent year, according to new analysis published today by the UK BioIndustry Association (BIA) and Radnor Capital Partners.

The study reveals 24 new American and 16 new European finance houses invested in the UK biotech sector for the first time, showing global recognition for UK innovation. 20 new UK institutional investors also entered the sector as other sectors of the economy were hit by the impacts of the pandemic. The findings show the importance of including biotech and healthcare in investment portfolios as part of both risk management and growth strategies.

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Venture Capital Funding Report Q4 2020 – CB Insights Research

2020 INVESTMENTS HIT NEW ANNUAL RECORD DESPITE THE PANDEMIC

US-based, VC-backed companies raise nearly $130B in 2020, up 14% year-over-year (YoY) from 2019, despite the impacts of Covid-19 around the world.

However, annual deal activity is down YoY, falling to 6,022 deals, a 9% decline from 6,599 in 2019.

Image: https://www.cbinsights.com

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SBA Announces Recipients of Tibbetts Awards for Demonstrating Significant Economic and Social Impact from R&D Funding

Washington, Jan. 14, 2021 (GLOBE NEWSWIRE) — Today, the U.S. Small Business Administration announced 38 companies, seven organizations and 14 individuals as the winners of the prestigious Tibbetts Award for their accomplishments in creating cutting-edge technologies. The Tibbetts Awards, named after Roland Tibbetts, the founder of the SBIR Program, honors these awardees for the exceptional successes they achieved through SBA’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.

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All Rights Reserved.



438th Edition, January 12, 2021

By BHI Weekly News Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


January 13, 2021












FOUNDING MEMBER OF



Chris Mathia, Chief Executive Officer, Innara Health, and Keith Molzer, Managing Partner, Flyover Capital, join Rich Bendis from Kansas City on BioTalk

While home in Kansas City for the season, BioTalk host Rich Bendis virtually sits down two local business leaders. Innar Health CEO, Chris Mathia, and Flyover Capital Managing Partner, Keith Molzer chat about the opportunities and challenges of BioHealth and Fund-Raising in Middle American.

Listen now via Google http://bit.ly/39ikNss, Apple http://apple.co/3shRRtk, Spotify http://spoti.fi/39ocgUz, and TuneIn http://bit.ly/2XvT0za.

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SBIR Virtual Office Hours (BHI and MCEDC)

Wednesday, January 13, 2021

Are you an early stage company with innovative biohealth technology? Have you considered non-dilutive funding to advance your technology? Do you want to know if federal or state non-dilutive funding makes sense for you? Sign up for a free 1:1 advice and feedback session regarding non-dilutive funding applications with BHI’s expert grant strategists. Learn more about funding sources and discuss potential strategies for success. BHI has worked with over 100 companies, helping them secure SBIR/STTR and other federal awards —at twice the national average win rate.

Click here to schedule a time.

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REGENXBIO Announces Proposed Public Offering Of Common Stock

ROCKVILLE, Md., Jan. 6, 2021 /PRNewswire/ — REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it intends to offer and sell, subject to market conditions, $175,000,000 of its common stock in an underwritten public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. In addition, REGENXBIO intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of common shares sold in connection with the offering.

BofA Securities, Morgan Stanley and Barclays are acting as joint book-running managers of the offering.

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NexImmune Strengthens Scientific Leadership by Appointing Jerome Zeldis as EVP R&D and Jeffrey Weber as Chief Scientific Advisor

GAITHERSBURG, MD — January 04, 2021 – NexImmune, a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent and durable immune response that mimics natural biology, today announced the hiring of veteran biopharmaceutical industry leader Jerome (Jerry) Zeldis, MD, PhD, as Executive Vice President of Research & Development and the appointment of leading immunotherapy expert Jeffrey Weber, MD, PhD, as Chief Scientific Advisor and Scientific Advisory Board Chair.

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Behrman Capital’s Emmes acquires Neox

Headquartered in Prague, Czech Republic, Neox is a CRO with over 150 employees who support biotechnology, pharmaceutical, and medical device customers. Neox has provided clinical research support for more than 1,000 studies and has built deep experience across multiple therapeutic areas. The company has operations primarily in central and eastern Europe, with a direct presence in the Czech Republic, Bulgaria, Germany, Hungary, Poland, Romania, Slovakia and Slovenia.  Neox operates in another 11 European countries, including a recently established entity in the United Kingdom.

 

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Emergent BioSolutions Secures DOD Aid for Covid Treatment Test – TheStreet

Emergent BioSolutions (EBS) – Get Report shares rose Wednesday after the life sciences company and Mount Sinai Health System announced a trial for Emergent’s coronavirus preventative with $34.6 million of support from the Pentagon.

Emergent recently traded at $92.70, up 2.84%, and has surged 71% year to date amid investor enthusiasm for companies involved with Covid treatments.

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Children’s National Hospital, NIH launch COVID-19 diagnostics AI challenge

Washington, D.C.-based Children’s National Hospital is partnering with the National Institutes of Health and tech firm NVIDIA to launch a challenge in which participants will develop artificial intelligence tools to improve the detection of COVID-19 in the lungs, the hospital announced Jan. 7.

Participants in the COVID-19 Lung CT Lesion Segmentation Grand Challenge will use a multi-institutional, multinational NIH dataset that houses data on patients with a diverse range of age, gender and disease severity to create AI-powered imaging models to help clinicians better identify and treat COVID-19 infection in patients’ lungs.

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Maxcyte | Myeloid Therapeutics and MaxCyte Enter Clinical and Commercial Licensing Agreement to Advance Myeloid’s Cell Therapy Programs

CAMBRIDGE, MA and GAITHERSBURG, MD, January 11, 2021 — Myeloid Therapeutics, Inc., a company harnessing and reprogramming yeloid cells to treat cancers, and MaxCyte, Inc., a global cell-based therapies and life sciences company, today announce the signing of a clinical and commercial licensing agreement.

Myeloid Therapeutics will obtain non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. This agreement enables Myeloid to advance its pipeline programs, including for engineered cell therapies targeting solid tumors, T cell lymphoma, and glioblastoma. In return, MaxCyte is entitled to receive undisclosed development and approval milestones, and sales-based payments, along with other licensing fees.

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Veralox Therapeutics Announces IND Submission for VLX-1005 to Treat Heparin-Inducted Thrombocytopenia

FREDERICK, Md – January [XX], 2021 – Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced it submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1 clinical trial of VLX-1005, a first-in-class small molecule inhibitor of 12-Lipoxygenase in development for the treatment of heparin-induced thrombocytopenia (HIT).

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Maryland Gov. Larry Hogan proposes $1B stimulus bill, including checks for low-income households and tax relief – Baltimore Business Journal

Gov. Larry Hogan on Monday unveiled a state economic relief package designed to put money into the pockets of low-income Marylanders, help businesses stay afloat and forgive hundreds of millions of taxes on unemployment benefits and other aid.

The $1 billion legislative package, which Hogan is introducing as emergency legislation when the General Assembly session begins Wednesday, is called the Recovery for the Economy, Livelihoods, Industries and Families (RELIEF) Act. Its purpose is to provide “immediate financial relief and tax cuts for Maryland working families, small businesses and those who have lost their jobs” during what Hogan summarized as “one of the worst economic crises in our country’s history.”

Image: Gov. Larry Hogan gives an update on the state’s coronavirus response during a Dec. 1 press conference. JOE ANDRUCYK/MARYLAND GOVPICS/CC 2.0/FLIC.KR/P/2KCWGCT

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Montgomery County biotechs received nearly $8B in research funding in 2020 | WTOP

COVID-19 vaccine research drove a lot of funding to biotechnology companies in Maryland’s Montgomery County last year, but it didn’t all come from coronavirus research.

Life sciences companies based in, or with a presence in, Maryland’s largest county received nearly $7.7 billion in research and development funding from the federal government, private investors and nonprofit organizations in 2020, according to the Montgomery County Economic Development Corp., a public/private partnership aimed at helping private companies connect with funding, permits and other resources.

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Noble Life Sciences announces its collaboration with George Mason University to access the National Center for Biodefense and Infectious Diseases BSL-3 facility – BioHealth Capital Region

Sykesville, MD, and Fairfax, VA, December 21, 2020 – Noble Life Sciences (NLS), a preclinical contract research organization located in Sykesville, MD, has signed a Collaboration Agreement with George Mason University (Mason) to access the National Center for Biodefense and Infectious Diseases (NCBID) BSL-3 facility located within their Biomedical Research Laboratory at Mason’s Science and Technology Campus in Manassas. The Agreement enables NLS to perform federal and non-federally funded BSL-3 animal model projects to support the development of new antiviral and antibacterial agents against infectious and resistant pathogens.

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Paul VanVeldhuisen, Ph.D., Named President of Emmes’ New Public Sector Group

ROCKVILLE, Md., Jan. 11, 2021 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that long-time employee, Dr. Paul VanVeldhuisen, has been named President of Emmes Public Sector.

Emmes is now organized into two business groups: Emmes Public Sector and Emmes Biopharma. The public sector group includes all the company’s existing federal government clients and contracts, as well as work for foundations, public/private sector partnerships, and not-for-profit organizations.

Image: Paul VanVeldhuisen – PRNewsfoto/Emmes

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TEDCO will provide $5M in COVID-19 aid for Maryland tech businesses – Technical.ly Baltimore

The state is providing aid for startups that are struggling to survive this economic downturn.

As part of an economic relief package announced by the State of Maryland in December, TEDCO will be making $5 million available for technology businesses that were hit hardest by the COVID-19 pandemic.

The funding will be available for technology-based businesses that are socially or economically disadvantaged, or based in rural areas, according to TEDCO, which is the quasi-public state agency that supports early-stage tech companies. The funding is expected to be made available in early February.

Image: Les Williams, CRO of Risk Cooperative, speaks at a TEDCO Builder Fund event. (Photo courtesy of TEDCO)

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Johnson & Johnson Nurses Innovate QuickFire Challenge on Mental Health

The Johnson & Johnson Nurses Innovate QuickFire Challenge in Mental Health, together with the American Psychiatric Nurses Association (APNA), invites nurses and nursing students worldwide to submit their nurse-led novel concepts, education programs, protocols, prevention or treatment approaches, screening tools, and consumer product ideas with the power to potentially transform mental health care and well-being for their fellow healthcare professionals or the patients they serve amid the current pandemic environment and beyond.

Areas of interest

  • Treatment protocols 
  • Health technologies 
  • Medical device 
  • Preventive approach 
  • Consumer product 
  • Community health approach 
  • Screening tools

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Johns Hopkins Coronavirus Resource Center passes 1 billion views | Hub

The Johns Hopkins Coronavirus Resource Center, a site launched in the spring of 2020 to offer critical data and perspective during the pandemic, logged its billionth page view today.

Launched March 3, the Coronavirus Resource Center has become a trusted destination for data on the spread and reach of COVID-19. Its continuously updated data trackers and tools help the public, policymakers, and health care professionals worldwide respond to the pandemic. The site includes the latest numbers on cases, testing efforts, and the vaccine rollout as well as expert analysis.

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CIT Announces Inaugural Solicitation for the New Commonwealth Commercialization Fund

Richmond, VA, Jan. 07, 2021 (GLOBE NEWSWIRE) — The Center for Innovative Technology (CIT) announced today its Request for Proposals (RFP) for the first solicitation under the newly formed Commonwealth Commercialization Fund (CCF).

The CCF was launched on July 1, 2020 to foster innovative and collaborative commercialization efforts in Virginia, consolidating two legacy programs: the Commonwealth Research Commercialization Fund (CRCF) and the Virginia Research Investment Fund (VRIF). In FY2021, CIT is conducting a single CCF solicitation for young Virginia companies that have strong potential to drive economic growth in Virginia, including through revenue and job creation. Up to $7 million is available to award; a one-to-one match is required.

This competitive round will provide grants up to $100,000 to support companies’ commercialization and market entry goals through product or service development, market research, intellectual property protection, marketing, pilots, and more. High-potential projects are sought in seven strategically important sectors: agricultural and environmental technologies, autonomous systems, clean energy, cybersecurity, data science and analytics, life and health sciences, and space and satellites. All Virginia companies that meet the eligibility criteria are invited to seek funding.

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Baltimore’s Port Covington Ramps Up After Financing Boost

With more than $650 million in financing in place, vertical construction in excess of 1.1 million square feet of mixed-use space at Port Covington in Baltimore is set to begin at the 235-acre redevelopment site along the city’s waterfront.

This $500 million development phase, known as Chapter 1B, includes 440,000 square feet of office, 586,000 square feet of residential with 537 units, 116,000 square feet of retail, more than 1,000 parking spaces and 10 acres of parks and public space.

Image: Port Covington. Image courtesy of Weller Development Co.

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Power Moves: These Baltimore tech firms are growing sales and biz dev teams to start 2021 – Technical.ly Baltimore

Ernesto Chanona joined Glen Burnie-based CSSi LifeSciences as its director of business development.

The organization works with companies to advance drugs and medical device technologies from discovery to commercialization.

“The onset of the COVID-19 pandemic has catalyzed business growth throughout the industry, and as such, CSSi LifeSciences is poised to expand in 2021,” Chanona said. “Initially, I’ll be focusing on managing the company’s early-stage clients, housed at incubators all over the world. Growing the pipeline through strategic partnerships with economic development agencies, incubators, universities and startups is also part of the plan.”

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Seven Biopharma Trends to Watch in 2021

Last year, when GEN prepared an editorial titled Eight Biopharma Trends to Watch in 2020, who could have foreseen COVID-19 and the deaths, illnesses, and economic disruption that the disease would wreak? And who could have foreseen how armies of industry and academic researchers would race to develop hundreds of new and repositioned vaccines and drugs? (GEN tracks more than 300 on its COVID-19 Drug and Vaccine Tracker webpage).

While biopharma was dominated by COVID-19, which prompted a surge of research and business activity, the industry also saw developments that will position it for further growth even after the virus is brought under control.

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How the coronavirus vaccine relies on Maryland’s strangest fishery: horseshoe crabs – Baltimore Sun

Far from the medical labs and test tubes, a fisherman in old rubber boots walks across the docks of West Ocean City to inspect his catch.

He peers in a crate of spiny tails and grasping claws, hundreds of a common yet precious creature, among the oldest species on Earth: horseshoe crabs.

The scene on the docks is a glimpse into a strange and guarded Maryland fishery, one supporting a multimillion-dollar industry as surprising as the catch itself — a seemingly alien creature with 10 eyes, 12 legs and magical, milky blue blood.

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Agreements reached between the United Kingdom of Great Britain and Northern Ireland and the European Union – GOV.UK

The Trade and Cooperation Agreement and other agreements below are provided for information only. No rights may be derived from them until the date of application. The numbering of the articles is provisional.

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Healthcare Investments & Exits 2021 Annual Report | Silicon Valley Bank

US healthcare venture fundraising soared in 2020, totaling $17B, a 57% increase over 2019’s record.

Image: https://www.svb.com

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All Rights Reserved.



437th Edition, January 5, 2021

By BHI Weekly News Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


January 5, 2021












FOUNDING MEMBER OF



Task force report outlines steps to build stronger post-pandemic economy in Maryland, Virginia, D.C. – The Washington Post

More than 50 local leaders have mapped out an economic recovery strategy for the Washington area that they say would leave it more unified, resilient and prosperous than before the novel coronavirus upended the region.

Connected DMV — a group representing the local academic, nonprofit, public and private sectors — initially came together in March 2019 to drive economic growth in the D.C. area. When the pandemic struck a year later, the group pivoted to creating what it calls a “strategic renewal” task force, which issued a report this month with 12 initiatives to remedy the region’s social and economic challenges.

Read More




SBIR Virtual Office Hours (BHI and MCEDC)

Wednesday, January 13, 2021

Are you an early stage company with innovative biohealth technology? Have you considered non-dilutive funding to advance your technology? Do you want to know if federal or state non-dilutive funding makes sense for you? Sign up for a free 1:1 advice and feedback session regarding non-dilutive funding applications with BHI’s expert grant strategists. Learn more about funding sources and discuss potential strategies for success. BHI has worked with over 100 companies, helping them secure SBIR/STTR and other federal awards —at twice the national average win rate.

Click here to schedule a time.

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Novavax Candidate COVID-19 Vaccine Moves into Phase III Trial

The National Institute of Allergy and Infectious Diseases (NIAID) announced the commencement of the Phase III trial (NCT04611802) of the Novavax investigational COVID-19 vaccine, in a press release issued on Monday, December 28, 2020. The trial will evaluate the effectiveness, immune response, and safety of a COVID-19 vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland, called NVX-CoV2373, and is estimated to complete data collection by March 31, 2021.

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Emmes Acquires Neox s.r.o., a Clinical Research Organization Headquartered in the Czech Republic

ROCKVILLE, Md., Dec. 30, 2020 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Neox s.r.o., a European-based CRO. Neox will add over 150 employees who support biotechnology, pharmaceutical, and medical device companies.

“This is an important and exciting step for Emmes, demonstrating significant progress on our strategic plans to grow our biopharmaceutical business,” said Dr. Christine Dingivan, Chief Executive Officer of Emmes. “Neox adds a sizable, well-established biopharmaceutical research services business to Emmes and significantly expands our international presence.”

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U.K. Authorizes Covid-19 Vaccine From Oxford and AstraZeneca – The New York Times

LONDON — Britain on Wednesday became the first country to give emergency authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, clearing the path for a cheap and easy-to-store shot that much of the world will rely on to help end the pandemic.

Image: https://www.nytimes.com – From Video

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7 Cell Therapy Companies in Maryland Helping to Revolutionize Drug Discovery: The Latest News | American Gene Technologies

Maryland is home to one of the largest life science clusters in the United States with more than 500 biotech companies. In addition to several state-of-the-art labs, Maryland is home to the NIH in Bethesda. Research opportunities, as well as BS and MS degree programs, are offered at Johns Hopkins in Baltimore and the University of Maryland in College Park. Montgomery College in Germantown offers the AAS degree and certificate programs in biotech. World-class training by companies like BioTrac and Biotech Primer attracts an international audience of professionals.

Image: https://www.americangene.com

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REGENXBIO Announces Agreement to Monetize Portion of Zolgensma® Royalties for $200 Million | BioSpace

ROCKVILLE, Md., Dec. 22, 2020 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it has entered into an agreement to sell a portion of the royalty rights due to REGENXBIO from Novartis Gene Therapies from the net sales of Zolgensma® to entities managed by Healthcare Royalty Management, LLC (HCR) for a gross purchase price of $200 million. This transaction provides immediate, non-dilutive capital to REGENXBIO for continued innovation in the development of potential breakthrough gene therapies for patients and completion of its internal manufacturing capabilities.

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BHI’s Judy Costello Recognized with BioBuzz Community Builder Award

BHI’s Managing Director, Economic Development, Judy Costello was recognized by voters in the 1st Annual BioBuzz awards this past week as the top Community Builder in the BioHealth Capital Region.  This award honors someone in the region who has gone above and beyond their responsibilities to make an impact on the ecosystem by being a thoughtful community builder who fosters intentional collaborations and meaningful contributions of their time, energy, and expertise to support the biohealth community. This person is a servant leader who sees beyond their job description or the balance sheet and strives to create a rising tide for all across the BioHealth Capital Region so that we can collectively make a greater impact on public health and patients around the world.

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BioTalk with Rich Bendis Wins BioBuzz Media Award

The BioTalk with Rich Bedis Podcast created by the BHI President & CEO and Andy Eckert was awarded the 1st Annual BioBuzz Media Award. This award honors a media campaign that most aligns with our mission; ‘to create exceptional experiences that better connect people and employers and foster a stronger regional ecosystem.’ At its core, it recognizes the media campaigns or platforms that have successfully engaged, informed, and connected people and reflect favorably on the BHCR. Eligible nominations may include social media, podcasts, video series, blog series, event or webinar series, and other advertising, marketing, and public relations campaigns.

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United Therapeutics Announces Agreement To Acquire Priority Review Voucher

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 28, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today an agreement to acquire a Rare Pediatric Disease Priority Review Voucher (PRV), which it plans to use with a forthcoming New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The PRV entitles the holder to designate an NDA for priority review and provides for an expedited eight-month review, instead of the standard twelve-month review period. Following the close of the transaction, United Therapeutics intends to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.

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Genetically Modified Pigs May Save Your Life: FDA Allows GMO Pigs

The U.S. Food and Drug Administration (FDA) has approved the second-ever genetically modified subtype of pig for human consumption. But there are no plans to raise this pig for meat or other foodstuffs—the use case is actually much, much cooler.

Get unlimited access to the weird world of Pop Mech. LET’S GET WEIRD. By adjusting the pig’s genes so it doesn’t produce a particular sugar called galactose-alpha-1,3-galactose (alpha-gal), scientists can make medicines that are safe for a group of people who suffer from a peculiar, little-understood allergy. And while this certification isn’t planned for meat, that could be next.

Image: TIM MACPHERSON

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Biotech Showcase™ | Investor conference | Co-produced by Demy-Colton and EBD Group

We are now only a few weeks out from Biotech Showcase and excited to launch the Spotlight Sessions on our on-demand hub on partneringONE.

We have also posted several Digital Medicine and Medtech Showcase sessions this week. Sponsor Insight content, on-demand public and private company presentations as well as Investor strategy videos are available for you to watch on demand.

Be sure to look at the sessions we have planned for the weeks of January 5 and 11.

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Dr. James Crowe, Director, Vanderbilt Vaccine Center, Guests on BioTalk

BioTalk Media Award-Winning Podcast BioTalk Welcomes Dr. James Crowe, Director, Vanderbilt Vaccine Center, Professor, Pediatrics and Pathology, Microbiology and Immunology, Ann Scott Carell Chair and Founder of ID Biologics.

Listen now on Apple http://apple.co/34u0kz6, Google http://bit.ly/38jfE2I, Spotify http://spoti.fi/3pddVme, and TuneIn http://bit.ly/37D2M8z.

His laboratory has a broad portfolio of work in the area of viral immunology and antibody sciences, with the goal to discover mechanisms of immunity important to developing new therapeutics and vaccines.

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How I Lost 65 Pounds In 18 Months Without Any Fad Diets or Gimmicks | by Mark Suster | Jan, 2021 | Both Sides of the Table

I’ve been reluctant to write this blog post because historically I don’t like talking about weight. But I’ve been promising to publish how I lost 65 pounds in the past 18 months without any fad diets or gimmicks to try and be helpful to others. I have a plan,

I know it works and for the friends and family who have followed what I’ve done they’ve equally lost a lot of weight.

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Copyright © BioHealth Innovation 2020
All Rights Reserved.



436th Edition, December 29, 2020

By BHI Weekly News Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


December 29, 2020












FOUNDING MEMBER OF



Task force report outlines steps to build stronger post-pandemic economy in Maryland, Virginia, D.C. – The Washington Post

More than 50 local leaders have mapped out an economic recovery strategy for the Washington area that they say would leave it more unified, resilient and prosperous than before the novel coronavirus upended the region.

Connected DMV — a group representing the local academic, nonprofit, public and private sectors — initially came together in March 2019 to drive economic growth in the D.C. area. When the pandemic struck a year later, the group pivoted to creating what it calls a “strategic renewal” task force, which issued a report this month with 12 initiatives to remedy the region’s social and economic challenges.

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Virginia Bio Will Direct New “Virginia Bio-Connect” Statewide Consortium to Strengthen Competitiveness of Virginia’s Life Science Ecosystem | Business Wire

RICHMOND, Va.–(BUSINESS WIRE)–Governor Northam and the Virginia Biotechnology Association announced today that GO Virginia has approved a competitive grant request to help fund Virginia Bio-Connect, a $3.2 million Statewide industry cluster scale up initiative. The project, directed by the Virginia Biotechnology Association, is a multi-regional collaboration designed to increase connectivity and awareness of the existing programs, resources, and communities in the Commonwealth that support the life sciences industry.

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Supernus Announces Positive Results from Phase III Study for SPN-812 in Adults with ADHD – Supernus Pharmaceuticals

ROCKVILLE, Md., Dec. 22, 2020 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from a Phase III study of SPN-812 in adults (P306) for the treatment of attention deficit hyperactivity disorder (ADHD).

At a daily dose of up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale (AISRS). In addition to meeting the primary efficacy endpoint, the Phase III study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in the change from baseline of the Clinical Global Impression – Severity of Illness (CGI-S) Scale at week 6. The active dose was well tolerated.

SPN-812 is under review by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in pediatric patients 6 to 17 years of age. As announced in November, 2020, the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients to indicate that the review cycle for the application was complete and that the application is not ready for approval in its present form. The Company will be meeting with the FDA in January 2021 to discuss the CRL. Assuming approval for pediatrics, the Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 in adults in the second half of 2021.

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REGENXBIO Announces Agreement to Monetize Portion of Zolgensma® Royalties for $200 Million | BioSpace

ROCKVILLE, Md., Dec. 22, 2020 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it has entered into an agreement to sell a portion of the royalty rights due to REGENXBIO from Novartis Gene Therapies from the net sales of Zolgensma® to entities managed by Healthcare Royalty Management, LLC (HCR) for a gross purchase price of $200 million. This transaction provides immediate, non-dilutive capital to REGENXBIO for continued innovation in the development of potential breakthrough gene therapies for patients and completion of its internal manufacturing capabilities.

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Novavax Announces Initiation of PREVENT-19 Pivotal Phase 3 Efficacy Trial of COVID-19 Vaccine in the United States and Mexico | Novavax Inc. – IR Site

GAITHERSBURG, Md., Dec. 28, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company’s COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated.

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Genetically Modified Pigs May Save Your Life: FDA Allows GMO Pigs

The U.S. Food and Drug Administration (FDA) has approved the second-ever genetically modified subtype of pig for human consumption. But there are no plans to raise this pig for meat or other foodstuffs—the use case is actually much, much cooler.

Get unlimited access to the weird world of Pop Mech. LET’S GET WEIRD. By adjusting the pig’s genes so it doesn’t produce a particular sugar called galactose-alpha-1,3-galactose (alpha-gal), scientists can make medicines that are safe for a group of people who suffer from a peculiar, little-understood allergy. And while this certification isn’t planned for meat, that could be next.

Image: TIM MACPHERSON

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Quantum technology is moving from the lab to startups. Here’s why it’s a strength for UMD – Technical.ly Baltimore

Advances in technology that shape the future come in different forms. Some help us realize possibilities of systems that already exist. Others allow us to reframe what’s possible.

Take computing, for instance. Advances in transistors over time have produced more powerful processors that can fit into ever smaller and more affordable packages. This has made it possible to do computing tasks more efficiently and conveniently, but in the end these improvements apply the same principles of classical computing that were used when there were room-sized mainframes.

Image: Sarah Kreikemeier tunes an optical assembly at IonQ’s offices. (Photo courtesy IonQ/Erin Scott)

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End of Year Update: 2020 Life Science Venture Capital Funding Roundup in the BioHealth Capital Region · BioBuzz

This has certainly been a year unlike any other for BioHealth Capital Region (BHCR) life science companies of all sizes and kinds. Just a few months into 2020, the coronavirus pandemic swept the region, seriously disrupting, albeit temporarily, the best-laid plans of aspiring founders, entrepreneurs, emerging startups, pre-clinical and more established, larger biohealth organizations in Virginia, Washington, D.C., and Maryland.

Image: https://biobuzz.io

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United Therapeutics Announces Agreement To Acquire Priority Review Voucher

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 28, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today an agreement to acquire a Rare Pediatric Disease Priority Review Voucher (PRV), which it plans to use with a forthcoming New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The PRV entitles the holder to designate an NDA for priority review and provides for an expedited eight-month review, instead of the standard twelve-month review period. Following the close of the transaction, United Therapeutics intends to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.

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Venture capitalist injects £10m into Oxford vaccine firm Vaccitech | This is Money

A biotechnology company whose research and intellectual property has helped to create the Oxford-AstraZeneca Covid vaccine has raised new investment from venture capitalists.

Oxford-based Vaccitech has agreed the funds – understood to be as much as £10million – from Future Planet Capital which also invests in health, climate change and education projects.

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Johns Hopkins Team Wins Global COVID-19 Mask Design Challenge – CBS Baltimore

BALTIMORE (WJZ) — A team from Johns Hopkins University won a global mask design challenge.

Two dozen undergraduates from the university make up Team Polair. Together, they created a clear mask they said people would want to wear.

Image: https://baltimore.cbslocal.com

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Exclusive: D.C. med-tech startup Nanochon raising new funding for 3D-printed implant for joint injuries – Washington Business Journal

Nanochon is aiming to close the round in January to fund the first human study of its product.

Image: Ben Holmes is co-founder and CEO of Nanochon. COURTESY BEN HOLMES

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These breakthroughs will make 2021 better than 2020 | LinkedIn

The latest on the innovations that will let us go back to normal. This has been a devastating year. More than 1.6 million people have died in the COVID-19 pandemic, with more than 75 million cases and tens of trillions of dollars in economic damages. Millions of people are out of work and struggling to pay their bills, and more than a billion children are missing out on crucial time in school. In the U.S., this year also saw the horrifying killings of George Floyd and Breonna Taylor, ruinous wildfires, and a presidential election unlike any other in modern times.

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DC Inno – The top D.C.-area innovation stories of 2020

It’s tempting to look forward to the new year — especially after such an abysmal 2020 for so many.

But before we do, let’s not forget all that happened in the region’s innovation ecosystem this year. It wasn’t all bad.

Here, we recap some of the top trends, events and topics over the last 12 months.

Image: Husband-wife co-founders Matthew and Marnel Goins run Puzzle Huddle, which saw increased demand amid stay-at-home orders, school closures and the refocus on supporting Black-owned businesses. Puzzle Huddle

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Copyright © BioHealth Innovation 2020
All Rights Reserved.



435th Edition, December 22, 2020

By BHI Weekly News Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


December 22, 2020












FOUNDING MEMBER OF



Dr. James Crowe, Director, Vanderbilt Vaccine Center, Guests on BioTalk

BioTalk Media Award-Winning Podcast BioTalk Welcomes Dr. James Crowe, Director, Vanderbilt Vaccine Center, Professor, Pediatrics and Pathology, Microbiology and Immunology, Ann Scott Carell Chair and Founder of ID Biologics.

Listen now on Apple http://apple.co/34u0kz6, Google http://bit.ly/38jfE2I, Spotify http://spoti.fi/3pddVme, and TuneIn http://bit.ly/37D2M8z.

His laboratory has a broad portfolio of work in the area of viral immunology and antibody sciences, with the goal to discover mechanisms of immunity important to developing new therapeutics and vaccines.

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BHI’s Judy Costello Recognized with BioBuzz Community Builder Award

BHI’s Managing Director, Economic Development, Judy Costello was recognized by voters in the 1st Annual BioBuzz awards this past week as the top Community Builder in the BioHealth Capital Region.  This award honors someone in the region who has gone above and beyond their responsibilities to make an impact on the ecosystem by being a thoughtful community builder who fosters intentional collaborations and meaningful contributions of their time, energy, and expertise to support the biohealth community. This person is a servant leader who sees beyond their job description or the balance sheet and strives to create a rising tide for all across the BioHealth Capital Region so that we can collectively make a greater impact on public health and patients around the world.

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BioTalk with Rich Bendis Wins BioBuzz Media Award

The BioTalk with Rich Bedis Podcast created by the BHI President & CEO and Andy Eckert was awarded the 1st Annual BioBuzz Media Award. This award honors a media campaign that most aligns with our mission; ‘to create exceptional experiences that better connect people and employers and foster a stronger regional ecosystem.’ At its core, it recognizes the media campaigns or platforms that have successfully engaged, informed, and connected people and reflect favorably on the BHCR. Eligible nominations may include social media, podcasts, video series, blog series, event or webinar series, and other advertising, marketing, and public relations campaigns.

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Biotech Firm to Expand in Washington’s Maryland Suburbs

Qiagen North American Holdings has announced plans to renovate and expand its U.S. headquarters and R&D and manufacturing facility in Montgomery County, Md.

More specifically, Qiagen plans to renovate its 146,000-square-foot facility at 19300 Germantown Road in Germantown, Md., to accommodate expanded production of testing products for COVID-19 and other diseases, as well as lease additional space in the area.

Image: Image by DarkoStojanovic via Pixabay.com

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5 Questions with Brian Darmody, CEO, Association of University Research Parks · BioBuzz

“5 Questions With…” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features 5 Questions with Brian Darmody, CEO, Association of University Research Parks (AURP).

Brian Darmody is CEO of AURP, a global nonprofit representing research parks and innovation districts sponsored by universities, federal labs, communities, hospitals, and other institutions in the US and 12 other countries.

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MacroGenics wins FDA approval to sell its first product, Margenza – Washington Business Journal

The 20-year-old company’s first product tackles certain breast cancers.

Image: Dr. Scott Koenig is president and CEO of Rockville biotech MacroGenics. JOANNE S. LAWTON

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MacroGenics Enters Research Collaboration with Janssen to Develop Novel DART® Molecule

ROCKVILLE, MD, Dec. 18, 2020 (GLOBE NEWSWIRE) —

MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, announced today a research collaboration and global license agreement to develop a preclinical bispecific molecule with Janssen Biotech, Inc. The research collaboration will incorporate MacroGenics’ proprietary DART® platform to enable simultaneous targeting of two undisclosed targets in a therapeutic area outside oncology.

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Noble Life Sciences announces its collaboration with George Mason University to access the National Center for Biodefense and Infectious Diseases BSL-3 facility

Sykesville, MD, and Fairfax, VA, December 21, 2020 – Noble Life Sciences (NLS), a preclinical contract research organization located in Sykesville, MD, has signed a Collaboration Agreement with George Mason University (Mason) to access the National Center for Biodefense and Infectious Diseases (NCBID) BSL-3 facility located within their Biomedical Research Laboratory at Mason’s Science and Technology Campus in Manassas. The Agreement enables NLS to perform federal and non-federally funded BSL-3 animal model projects to support the development of new antiviral and antibacterial agents against infectious and resistant pathogens.

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The Hemafuse Solution To Donor Blood Challenge In Ghana – DailyGuide Network

The hemafuse set contains a big syringe, which acts as the collection barrel, a nozzle connected to a filter on the syringe pulls the blood in while sieving the clots.

With a push, the blood is redirected through another tube, connected to the same syringe and operated by a stopcock, to the blood bag for transfusion back to the patient.

Image: Dr Gerald Osei-Owusu with the hemafuse medical device – https://dailyguidenetwork.com

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BRAINBox Solutions Announces Enrollment Begins in Pivotal, HeadSMART II Clinical Study of BRAINBox TBI Concussion Diagnostic and Prognostic Test

RICHMOND, VA. (December 16, 2020) ‐ BRAINBox Solutions today announced it is beginning enrollment in its pivotal clinical trial, HeadSMART II (Head injury Serum markers and Multi-modalities for Assessing Response to Trauma), of the company’s concussion diagnostic and prognostic test, BRAINBox TBI. The multi-national, multi-site trial, which will enroll up to 2,000 patients, aims to generate data to support an application for regulatory clearance by the U.S. FDA.

The BRAINBox TBI (Traumatic Brain Injury) test will be the first objective test designed to assist in the diagnosis of concussion and provide an assessment of the risk of chronic injury. The FDA has granted the test Breakthrough Device designation.

“We do not have a validated objective method to determine an early TBI diagnosis. While a head CT identifies anatomic abnormality, it does not predict post-concussive symptoms or disability at the time when interventions change outcomes. We need an early objective test,” said W. Franklin Peacock MD FACEP, the Principal Investigator of the study. Dr. Peacock is Professor of Emergency Medicine and Vice Chair for Research in the Department of Emergency Medicine at Baylor College of Medicine.

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COVID-19 vaccine deployment tracked in Johns Hopkins dashboard – Business Insider

As health agencies across the US rush to distribute the first round of COVID-19 vaccines, a new online tool aims to track their progress.

A dashboard hosted by Johns Hopkins University shows how many doses of COVID-19 vaccines have been administered across the US, according to publicly available data published by state health agencies and aggregated by the Centers for Civic Impact.

 

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GSK puts up to $815M on the table for Surface Oncology’s antibody | FierceBiotech

GlaxoSmithKline is stumping up $85 million upfront and up to an extra $730 million in biobucks for Surface Oncology’s early-stage antibody asset.

The drug the U.K. pharma is betting on, known as SRF813, is a fully human, IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells and T cells.

In preclinical tests, Surface Oncology says, SRF813 has shown the “potential to elicit a strong anti-tumor response and promote immunological memory.” It’s still only in IND-enabling studies, but the company has an IND planned for next year.

Image: (GlaxoSmithKline)

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Weller Development’s Port Covington project gets boost as $137.5 million in bonds hit market – Baltimore Business Journal

Work on the $5.5 billion project has been at a standstill since April due to the Covid-19 pandemic.

Image: Work on the $5.5 billion redevelopment at Port Covington was shut down in April amid the Covid-19 pandemic. Developer Marc Weller previously said it would not resume until the TIF bonds were sold. MELODY SIMMONS

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State officials launch Maryland Business Innovation Challenge | News | myeasternshoremd.com

BALTIMORE — The Maryland Department of Commerce is partnering with the Maryland Business Innovation Association to launch the Maryland Business Innovation Challenge, a program aimed at bringing together the state’s corporate community with local innovators to solve real-time business challenges.

Image: https://www.myeasternshoremd.com

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AstraZeneca to acquire Alexion for $39 billion in blockbuster deal

AstraZeneca on Saturday said it was acquiring Alexion Pharmaceuticals for $39 billion, marking a significant expansion into the treatment of rare diseases of the immune system.

The deal — a mix of cash and stock — values Alexion at $175 per share, a 45% premium to Friday’s closing stock price.

Image: KRISTOFFER TRIPPLAAR/SIPA/AP

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NIST/Industry Developed Temperature Tracking Device for Packages May Have Climate Metrology Applications | NIST

National Institute of Standards and Technology (NIST) researchers are working to reduce the uncertainty associated with climate-change measurements using a mobile temperature-sensing technology made for tracking delicate or perishable, high-value packages in transit. Developed by international shipper FedEx and tested with help from NIST, the device connects to cell phone networks to provide users with near real-time information on the package’s precise location, temperature, humidity, pressure, acceleration, elevation and exposure to light.

Image: Credit: Strouse/NIST Developed by international shipper FedEx and tested with help from NIST, the Senseaware device connects to cell phone networks to provide users with near real-time information on a packages precise location, temperature, humidity, pressure, acceleration, elevation and exposure to light. NIST researchers plan to deploy the technology as part of a pilot project to monitor and improve climate measurements.

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FDA approves new genetically modified pig for allergy-free medical and food products – KTVZ

The US Food and Drug Administration said Monday it has approved a genetically modified pig whose body doesn’t make a component that can trigger allergies in people.

The pigs should produce meat that is safe to eat, and organs and tissues safe for transplants and for the other biomedical uses for people allergic to the compound — a sugar found on the surface of animal cells known as alpha-gal, the FDA said.

 

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Springboard Enterprises Appoints Natalie Buford-Young as its First CEO | LinkedIn

Celebrating 20 years of supporting women-led companies and industry transformation, Springboard Enterprises announces Natalie Buford-Young as its first CEO. Buford-Young will work alongside Springboard President and co-founder Amy Millman, broadening the breadth and depth of the organization.

To date, Springboard’s portfolio numbers 819 women-led companies, which have created $27.2 Billion in value.

In her role, Buford-Young will be responsible for leading Springboard’s mission to accelerate the growth of entrepreneurial companies led by women through access to essential resources and a global community of experts. An accomplished and innovative corporate executive, entrepreneur, and community builder, Buford-Young joins from Deloitte, where she served as Managing Director of Market Development for Deloitte’s venture capital, private equity and emerging private company practices.

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MacKenzie Scott Donates Tens of Millions to Maryland HBCUs – NBC4 Washington

Philanthropist and author MacKenzie Scott is donating tens of millions of dollars to historically black universities in Maryland.

The Baltimore Sun reported Tuesday that the schools are Morgan State, Bowie State and the University of Maryland Eastern Shore.

Image: As shipments of Moderna’s vaccine begin, health officials warn the public not to get complacent. News4’s Darcy Spencer has the warning from a local doctor about Christmas travel and gatherings. – https://www.nbcwashington.com

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Term Sheet Recommendations for Launching University Life Science Startups (VC / TTO Roundtable, Spring 2020) | Technology Ventures

In the Spring of 2020, members from seven university tech transfer offices met with partners from six venture capital firms to discuss challenges both parties routinely face when working on life science deals together. Below is the resulting set of best practices, meant to benefit universities and VCs more broadly. Individuals interested in sharing feedback on the below guidelines should contact techventures@columbia.edu and include their name, organization, and work email. Please note that not all of these recommendations may be appropriate for startups outside of the life sciences. Comments and feedback will be posted at the bottom of this page.

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Home | About BHI | BHI News | Programs | Partners | Contact

Copyright © BioHealth Innovation 2020
All Rights Reserved.



434th Edition, December 15, 2020

By BHI Weekly News Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


December 15, 2020












FOUNDING MEMBER OF



AstraZeneca to acquire Alexion for $39 billion in blockbuster deal

AstraZeneca on Saturday said it was acquiring Alexion Pharmaceuticals for $39 billion, marking a significant expansion into the treatment of rare diseases of the immune system.

The deal — a mix of cash and stock — values Alexion at $175 per share, a 45% premium to Friday’s closing stock price.

Image: KRISTOFFER TRIPPLAAR/SIPA/AP

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Qiagen, producer of COVID tests, to expand in Germantown, add 300 jobs – Maryland Daily Record

Qiagen, an international life sciences company that provides molecular sample and assay technologies, is expanding its United States headquarters in Germantown to accommodate increased production of testing products for COVID-19 and other diseases. The company, which is based in the Netherlands, has already spent over $7 million on new equipment and improvements to its 146,000-square foot …

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EIR Feedback (BHI) – Wednesday, December 16, 2020 – Biohealth Innovation

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

 

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COVID-19 Strategic Renewal Task Force Report | ConnnectedDMV

COVID-19 STRATEGIC RENEWAL TASK FORCE REPORT

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2020: The Human Immunome: Small Moves Become a Movement — The Golden Goose Award

The Human Immunome: Small Moves Become a Movement

“We’re basic scientists. We did not set out initially just to make drugs. That’s not what it was about when we started. I’ve just always been interested in how the human immune system even recognizes a virus,” says James E. Crowe, Jr., a well-known infectious disease expert who directs the Vanderbilt Vaccine Center in Nashville, Tennessee. “Now we can study how the body works and have curiosity about that, but also have drugs in the pipeline. It’s the unexpected benefit we get by delving deeply into the human immune system.” Crowe is one of the recipients of the 2020 Golden Goose COVID-19 Recognition for his decades-long pursuit of a better understanding of the human immune system, which is now paying dividends in the fight against COVID-19.

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United Therapeutics Receives FDA Orphan Drug Designation For Treprostinil For The Treatment Of Idiopathic Pulmonary Fibrosis

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 9, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). United Therapeutics intends to initiate a phase 3 study, called TETON, to evaluate the use of Tyvaso® (treprostinil) Inhalation Solution in patients with IPF. FDA recently cleared United Therapeutics’ investigational new drug application (IND) for the TETON study, and the company expects to commence enrollment in 2021. Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. This exclusivity would also benefit Treprostinil Technosphere®, United Therapeutics’ next-generation dry powder inhalation form of treprostinil, upon FDA approval of that product for the IPF indication.

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USM COVID Research & Innovation Task Force Launches Student PSA Public Health Challenge – USM

Baltimore, Md. (Dec. 11, 2020) – The University System of Maryland (USM) COVID Research and Innovation Task Force is bringing together people, expertise, and resources from its 12 universities to rapidly advance solutions to challenges presented by the COVID-19 pandemic. With the generous support of several local organizations, the Task Force is inviting members of the USM community to take part in a multimedia, Public Health Challenge seeking creative submissions that highlight ways for USM students, members of the broader university community, and all Marylanders to stay safe and healthy while waiting for a vaccine to become available.

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Funding Opportunities | MSCRF – 1/14 Deadling to Apply

We offer six programs to accelerate discovery and commercialization of human stem cell-based technologies. Please verify eligibility, read the appropriate RFA below and apply here.

Companies or Universities/Research Institutes that wish to conduct human stem cell-based clinical trials in the State of Maryland. 1:1 match of non-state money is required. IND required

 

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Novavax Appoints Vaccine Industry Expert Margaret G. McGlynn to Board of Directors | Novavax Inc. – IR Site

GAITHERSBURG, Md., Dec. 09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Margaret G. McGlynn, R. Ph. to its board as an independent director. Ms. McGlynn brings extensive pharmaceutical industry, vaccine and non-profit experience to her role on the Novavax Board of Directors.

“Margie’s deep experience in vaccine commercialization and understanding of global public health will be invaluable as we move closer to collecting Phase 3 clinical data and submitting NVX-CoV2373, our COVID-19 vaccine candidate, for regulatory authorization and approval,” said Stanley C. Erck, Novavax President and Chief Executive Officer.

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REGENXBIO Announces Positive Interim Data and Update for Phase I/II Trial of RGX-121 for the Treatment of MPS II | BioSpace

ROCKVILLE, Md., Dec. 8, 2020 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced interim data from Cohorts 1 and 2 of the ongoing Phase I/II trial of RGX-121 for the treatment of patients up to 5 years old diagnosed with Mucopolysaccharidosis Type II (MPS II). In addition, REGENXBIO announced plans to evaluate a higher dose of RGX-121 in a third cohort of patients at an increased dose of 2.0×1011 GC/g brain mass. REGENXBIO expects to begin enrolling patients in Cohort 3 in the first quarter of 2021.

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Liquid Biopsy Predicts Esophageal Cancer Patient Response to Treatment | Business Wire

ROCKVILLE, Md.–(BUSINESS WIRE)–Creatv MicroTech, a privately-held biotechnology company has pioneered a blood test to predict treatment response in patients with newly diagnosed Stage I-III esophageal cancer (EC) treated with chemoradiation therapy (CRT). The results were published in the Journal of Translational Medicine. Creatv’s collaborator MD Anderson Cancer Center recruited patients for the study under standard of care CRT and IRB approved protocol. “We are delighted to present a method to stratify patients with EC who are responding to CRT using a single tube of blood,” said Dr. Cha-Mei Tang, CEO of Creatv. “Now, patients who are not responding to CRT can be identified quickly for alternative therapy.” Currently, no other blood test predicts treatment response for Stage I-III esophageal cancer therapies.

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Avoid these 5 real-world data pitfalls when planning your patient registry, cohort study, or observational clinical study

When clinical investigators and study coordinators start planning a new study design, speed and efficiency are paramount.

Running a clinical study takes careful planning. Whether this is your 1st clinical study or your 21st, the last thing you probably want to do is waste time and resources on data collection delays that are easy to prevent.

Traditionally, major bottlenecks occur during study startup, eligibility screening, the informed consent period (including assent in pediatric studies), and patient travel to the clinical site(s). Researchers eager to get the ball rolling on their study can save time and ease logistical burdens by stopping data gridlock before it begins.

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Vaccitech, Future Planet backed Oxford Spinout, Offers Global Path to End of COVID-19 — Future Planet Capital

This week, interim Phase III data was released for the Oxford / AstraZeneca Vaccine, co-invented by our portfolio company Vaccitech. From late December, assuming the full dataset has been analysed and confirmed to meet formal regulatory requirements, AstraZeneca has announced that they believe they will be in a position to provide a vaccine for a quarter of the world’s population. The vaccine will not just benefit the UK, EU and US who have ordered millions of doses, but the developing world, too. The Serum Institute of India has already begun producing 1 billion doses for the global south.

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Emmes Announces its Contribution to Second Remdesivir Clinical Trial for COVID-19 | BioSpace

ROCKVILLE, Md., Dec. 14, 2020 /PRNewswire/ — Emmes today announced that it has conducted the data and statistical analysis for the second iteration of the Adaptive COVID-19 Treatment Trial (ACTT-2). The ACTT-2 trial assessed the efficacy and safety of a 4-mg dose of baricitinib with remdesivir, versus remdesivir alone, in hospitalized COVID-19 patients.

Baricitinib, produced by Eli Lilly and Company, has been used to treat adults with moderate to severe rheumatoid arthritis. Baricitinib, in combination with remdesivir for COVID-19 patients, received Emergency Use Authorization on November 19.

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COVID-19 — The Disease That Is Reshaping Manufacturing | NIST

Unless you’ve been living on private island (send invite immediately!), it’s no secret that the pandemic has changed the way manufacturers operate and run their businesses in order to survive these challenging times.

At least that’s what we at the National Institute of Standards and Technology’s Manufacturing Extension Partnership (NIST MEP) have heard from manufacturers over 11 virtual listening sessions we call the “National Conversation with Manufacturers.”

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Reflecting on 2020 and Wishing You Happy Holidays

Though it began like any other year, 2020 has proven to be one of the most difficult and frustrating periods of our lifetime. This was especially true for our business community, which faced numerous new obstacles including shifting consumer needs, new safety requirements and a general uncertainty about what lay ahead.

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George Washington University, US Patent Innovations targeting cancer and Covid in $3.2M corporate research agreement – Washington Business Journal

The university licenses its original patent to the company to develop the product and conduct early-stage clinical trials.

Image: Michael Keidar, a mechanical engineer by training, is a professor of engineering at George Washington University. WILLIAM ATKINS

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The Enactment of Bayh-Dole, An Inside Perspective – IPWatchdog.com | Patents & Patent Law

We caught the tide– but just barely. That the Bayh-Dole Act passed was amazing. That it passed in a lame duck session of Congress with its principal author defeated, the US Senate changing hands, and a sitting president thrown out, was a miracle. Even then success was not assured. The bureaucracy was waiting to undermine the implementing regulations. Yet the new law survived, strengthening the economy while improving public health and well-being.

Image: U.S. Senator Birch Bayh (ret.)

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Where In The World Should I Conduct My Pivotal Clinical Trial? · BioBuzz

The COVID pandemic has certainly forced us to re-think the whole paradigm of conducting clinical trials. From design, site and CRO selection, patient recruitment, data management, to execution, the world of clinical trials has been altered significantly in 2020… and most likely beyond.

Here are some relevant questions you should be asking yourself and that we will be asking our panelists in today’s webinar:

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Novo Holdings: the world’s largest biotech investor | Sifted

What’s the world’s largest charitable foundation? Nope, its not the Bill and Melinda Gates Foundation. Not even the Wellcome Trust.

It’s Novo Nordisk Foundation, a $65bn endowment headquartered in Copenhagen.

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AUTM 2021 Conference

Top Reasons to Attend:

  • The world may have stopped, but your professional development doesn’t have to.
  • Education and networking from the comfort of your own couch.
  • Loads of partnering opportunities.
  • The programming is tops in the industry.
  • It’s a great value — in fact it’s a great year for the whole office to attend.
  • It’s an important investment in your future.

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435th Edition, December 8, 2020

By BHI Weekly News Archives

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December 8, 2020

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Connected DMV President & CEO Stu Solomon joins Rich Bendis on BioTalk
 

Stu Solomon, President & CEO, Connected DMV joins BioTalk to discuss formation of the Strategic Renewal Task Force, their Covid-19 Pandemic Pivot, the Global Pandemic Prevention and Bioterrorism Center, and much more.

Listen now on Apple https://apple.co/3gqmJlB, Google https://bit.ly/3mVtled, Spotify https://spoti.fi/3mO0j05, and TuneIn https://bit.ly/37FMf2t.

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BRAINBox Solutions Announces First Close in $23 Million in Series A Financing to Support Development and Pivotal Clinical Trial of ‘Breakthrough’ Concussion Diagnostic/Prognostic Test
 

Scott Gazelle, MD, PhD, MPH, FACR Appointed to Board of Directors and Damon Kuehl, MD, FACEP Joins Scientific Advisory Board

RICHMOND, Va. (December 4, 2020) ‐ BRAINBox Solutions today announced the initial closing on a $23 million Series A financing to support the clinical development of the company’s BRAINBox TBI (Traumatic Brain Injury) Test to aid both in the diagnosis and prognosis of mild TBI (concussion). BioVentures Investors led the financing round and was joined by the Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon LLC, Astia Angels and additional qualified investors, including Kevin Love, professional basketball player and mental health advocate.

“The BRAINBox TBI test has enormous potential to significantly improve patient care as an aid to objectively diagnosing and managing the treatment of concussion patients,” said Marc Goldberg, BioVentures Investors Co-Founder and Managing Partner. “The company has made great progress, particularly in this challenging COVID-19 environment, in advancing the development of the BRAINBox TBI testing system, including laying the groundwork for the pivotal, HeadSMART II clinical trial and securing ‘Breakthrough Designation’ from the FDA.” He noted there are more than five million patients evaluated in emergency rooms annually for mild TBI as well as additional patients in urgent care settings.

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EIR Feedback (BHI) – Wednesday, December 16, 2020 – Biohealth Innovation
 

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

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SBIR Virtual Office Hours – Wednesday 12/09/20 (BHI and MCEDC) – Biohealth Innovation
 

Are you and early stage company with innovative biohealth technology? Have you considered non-dilutive funding to advance your technology? Learn more about whether or not federal or state non-dilutive funding makes sense for you. Discuss potential strategies for success. Sign up for a free 1:1 advice and feedback regarding non-dilutive funding strategy and applications with BHI staff who have helped companies secured SBIR, STTR and other awards—at twice the national average win rate.

Click here to schedule a time.

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MacroGenics strikes commercialization deal with Eversana ahead of potential Food and Drug Administration approval for breast cancer treatment – Washington Business Journal
 

The agency’s decision is expected to drop Dec. 18.

Image: MacroGenics is led by CEO and co-founder Scott Koenig. JOANNE S. LAWTON

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QIAGEN to launch QuantiFERON SARS-CoV-2 for research into causes, spread and control of COVID-19 through T-cell response
 

Hilden, Germany and Germantown, Maryland, December 7, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today the launch of its QuantiFERON SARS-CoV-2 RUO solution that can detect T-cell responses of the human immune system to the pathogen that causes COVID-19, which could help researchers find out more about immunity levels and disease progression.

Studies suggest that T-cell response to SARS-CoV-2 declines much more slowly than antibody response, which presents several benefits to researchers who want to push beyond the existing detection of active infections to screen for potential courses of the illness and long-term immune responses to it. QIAGEN’s QuantiFERON SARS-CoV-2 Research Use Only (RUO) solution could be a valuable tool in this research.

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NEA Welcomes Scott Gottlieb, M.D., as Special Partner | NEA | New Enterprise Associates
 

Chevy Chase, MD – May 22, 2019 – New Enterprise Associates, Inc. (NEA), a leading global venture capital firm, today announced the appointment of Scott Gottlieb, M.D., as a Special Partner on the firm’s healthcare investment team. Dr. Gottlieb was a Venture Partner at NEA from 2007 to 2017 before being appointed the 23rd Commissioner of the U.S. Food and Drug Administration (FDA), where he served from 2017 to 2019.

Under Dr. Gottlieb’s leadership, the FDA advanced new policies for the safe and effective oversight of gene therapies, cell-based regenerative medicines, targeted drugs, and digital health devices; implemented new reforms to standardize drug and medical device reviews; and promoted policies to reduce death and disease from tobacco, improve food innovation and safety, promote better nutrition, and aggressively confront addiction crises.

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AstraZeneca Gears Up to Vaccinate the World Against Covid-19 – WSJ
 

Among the front-runners racing to deliver a Covid-19 shot, AstraZeneca PLC has the least vaccine experience. But it has promised the world the most doses—more than three billion.

The company has assembled an unprecedented network of manufacturing and distribution partners spanning the globe, complementing a series of deals with governments that have sought to lock in vaccine supplies for their countries.

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Novavax Expands Gaithersburg Real Estate Footprint As It Works On COVID-19 Vaccine
 

The effort to develop a COVID-19 vaccine is continuing to create new demand for life sciences space in Montgomery County, with one of the leading vaccine developers taking over a former industrial building and land previously planned for mixed-use development.

Novavax, a biotech company that has received $2B in funding for its COVID-19 work, announced Monday it signed a 122K SF lease at 700 Quince Orchard Road in Gaithersburg.

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REGENXBIO Announces Dosing of First Patient in Phase I/II Trial of RGX-111 for the Treatment of Mucopolysaccharidosis Type I | BioSpace
 

ROCKVILLE, Md., Dec. 1, 2020 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the first patient has been dosed in the Phase I/II trial of RGX-111 for the treatment of Mucopolysaccharidosis Type I (MPS I). RGX-111 is an investigational one-time gene therapy designed to deliver the α-l-iduronidase (IDUA) gene directly to the central nervous system (CNS) using the NAV AAV9 vector.

MPS I is a rare, autosomal recessive genetic disease caused by deficiency of IDUA, an enzyme required for the breakdown of the polysaccharides in lysosomes. These polysaccharides, called glycosaminoglycans (GAGs), accumulate in tissues of MPS I patients, resulting in characteristic storage lesions and diverse clinical signs and symptoms including in the central nervous system (CNS), which can include excessive accumulation of fluid in the brain, spinal cord compression, and cognitive impairment.

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CEL-SCI’s LEAPS Peptides Demonstrate Clear Survival Benefit as a Treatment for COVID-19 in Preclinical Studies | Business Wire
 

VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (NYSE American: CVM) announced today its LEAPS COV-19 peptides, delivered as a therapeutic treatment following SARS-CoV-2 virus challenge, achieved a 40% survival rate in transgenic mouse models as compared to 0% survival in the two control groups in studies conducted at the University of Georgia Center for Vaccines and Immunology.

Scientists at the University of Georgia working in conjunction with CEL-SCI’s scientific team conducted a challenge study in human(h) ACE2 receptor transgenic mice infected with a dose of SARS-CoV-2 (the causative agent of COVID-19 disease) virus sufficient to cause death in all animals within 8 days. This transgenic animal model is useful to study COVID-19 disease because the mice express the molecule that provides entry for the SARS-CoV-2 virus into human cells. Virus infection is optimized in this animal model providing an ideal system to determine vaccine induced immune protection or therapy against a SARS-CoV-2 infection of humans.

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First use of nView medical’s novel 3D imaging technology in pediatric spine surgery
 

Children’s National Hospital today performed the first surgical use of breakthrough medical imaging technology designed specifically for kids. The innovation, insta-3D™ imaging from company nView medical, is designed to make 3D images available in the operating room quickly and safely. The 3D images provide surgeons with better visualization, allowing them to continue improving patient care and outcomes.

Matthew Oetgen, M.D., division chief of Orthopaedic Surgery at Children’s National, is overseeing the first use of this 3D imaging technology in orthopaedic procedures.

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Alexandria Real Estate Equities, Inc. Receives Two #1 Global GRESB Rankings, and Earns 5 Star Rating for Highly Sustainable Development Initiatives and “A” Disclosure Score in the 2020 GRESB Assessment, Reinforcing Its ESG Leadership
 

PASADENA, Calif., Dec. 1, 2020 /PRNewswire/ — Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, today announced that it has been recognized as the #1 real estate company in the world in the Global Real Estate Sustainability Benchmark (GRESB) 2020 Science & Technology sector for its leadership in championing sustainability initiatives that promote the health and well-being of its tenants and employees and enhance local communities. Alexandria also earned the #1 global ranking and a 5 Star Rating—the highest GRESB Rating—in its Diversified Listed Peer Group for its highly sustainable development work and green building initiatives, as well as an “A” disclosure score for the third consecutive year. GRESB is one of the leading global environmental, social and governance (ESG) benchmarks for real estate and infrastructure investments across the globe.

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UMD computer scientist’s VisiSonics raises $3.5M to amplify 3D sound technology – Technical.ly Baltimore
 

When it comes to virtual reality, truly immersing someone in another space requires a lot of things to be just right. For one, there’s a question of visuals. The objects have to be three-dimensional enough to look like they’re in front of a player, and a character has to be able to move around to see those objects to the right or left.

Image: VR on the RMI Manufacturing Day demo floor in 2017. (Courtesy photo)

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Entrepreneurial Spirit: UMB Startups Receive Support from Maryland Momentum Fund – Catalyst Magazine
 

The University of Maryland, Baltimore (UMB) strives to support the entrepreneurial talents of its students, faculty, staff, and alumni as it works to improve the human condition and serve the public good.

To this end, the University System of Maryland (USM) continues to aid entrepreneurs at UMB and throughout the state with the $10 million Maryland Momentum Fund (MMF).

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Pitch Perfect: The Art and Science of Communicating with Investors
 

Pitch Perfect: The Art and Science of Communicating with Investors Before AND After Funding Communicating with investors before AND after funding is both an art and science. Learn best strategies at this truly informative webinar.

This free webinar is brought to you by the Society of Physician Entrepreneurs and the George Washington University Technology Commercialization Office.

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The Pinkney Innovation Complex for Science and Technology (PIC MC) Brings Together Innovation and Education · BioBuzz
 

The Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC) Combines Innovation and Education – a smart choice for co-location.

The BioHealth Capital Region has come to be known for its unique blend of Industry, Government, and Academia from Baltimore to Charlottesville. Unlike many of the other Biotech Hubs across the United States, the geographic spacing, which at times has been seen as a challenge in the region, has created new opportunities.

Image: https://biobuzz.io/

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BioInnovation Institute takes in new cohort of promising early-stage innovations – PharmiWeb.com
 

Seven start-up companies and university research projects across a range of therapeutic areas and geographical locations form latest intake for life science incubator BioInnovation Institute

COPENHAGEN, Denmark, 2nd December – BioInnovation Institute (BII), a Novo Nordisk Foundation initiative incubating and accelerating world-class life science research, today identifies its latest cohort of program participants. Comprising a pan-European spread of start-up companies and university research projects in countries including Denmark, Sweden and the UK, the seven ventures are developing revolutionary science across BII’s three sector specialised areas – therapeutics, bioindustrial and health tech.

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TEDCO’s Entrepreneur Expo 2019 – Recap | TEDCO
 

TEDCO’s 2019 Entrepreneur Expo took place on October 29, 2019, at The Hotel At The University of Maryland! See what Maryland has to offer entrepreneurs.

Image: https://www.tedcomd.com

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Doudna Talks Nobel Success and Women in Science
 

Jennifer Doudna PhD, the UC Berkeley biochemist who shared the 2020 Nobel Prize in Chemistry with Emmanuelle Charpentier PhD, was the recent guest of honor for the final episode in the “Women in Science” web series, co-organized by GEN and the Rosalind Franklin Society.

In 2012, the Doudna and Charpentier labs teamed up to publish a landmark paper in which they adapted the CRISPR microbial anti-viral defense system to create a programmable method for genome targeting. The work laid the foundation for CRISPR genome editing, which has become not only a ubiquitous research tool but also applied in clinical gene therapy, diagnostics, agriculture, and many other applications.

Image: https://www.genengnews.com

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434th Edition, December 1, 2020

By BHI Weekly News Archives




BioHealth Innovation


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December 1, 2020












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Novavax Announces COVID-19 Vaccine Clinical Development Progress | Novavax Inc. – IR Site

GAITHERSBURG, Md., Nov. 30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix‑M™.

“Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”

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Maryland Company Poised to Produce Millions of Point-of-Care COVID-19 Tests that Deliver Accurate Results in 15 Minutes · BioBuzz

Rockville, Maryland’s Maxim Biomedical (MaximBio) is on the cusp of bringing 3 million of its new and effective point-of-care COVID-19 tests to the fight against the coronavirus pandemic in early 2021, with a scale up to 15 million tests per month expected by Q2 2021. 

The company’s brand new point-of-care (POC), ready out-of-the-box antigen test is based on a Lateral Flow Assay technology (LFA) that produces visually interpreted results within 15 minutes. 

 

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Sisu’s Life Saving Hemafuse Device Introduced in Five Frontier Hospitals of Kenya – APO Group – Africa Newsroom / Press release

BALTIMORE, United States of America, October 29, 2020/APO Group/ — Sisu Global’s (SisuGlobal.health) flagship medical device is Hemafuse, a surgical autotransfusion device that is revolutionizing blood access across Africa. There is a global shortage of 100 millions units of donor blood worldwide, and only 40% of the demand for blood transfusions is met across Africa. The COVID-19 pandemic has dramatically worsened the global blood shortage as blood drives and large gatherings have been cancelled. Autotransfusion is the process of salvaging and retransfusing the patient’s own blood in cases of internal bleeding. Studies show that autotransfusion reduces a patient’s recovery time and risk of infection and removes the potential for rejection when compared to donor blood. Notably, autotransfusion is viable for cases of ruptured ectopic pregnancy. Other viable cases include blunt trauma, traffic accidents, and cardiac and orthopedic surgeries.

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AstraZeneca’s COVID-19 vaccine, up to 90% effective in late-stage trials, is being manufactured in Baltimore – Baltimore Sun

Late-stage trials showed that AstraZeneca’s coronavirus vaccine, which is being manufactured for the United States in Baltimore, was up to 90% effective, the English pharmaceutical company said Monday.

AstraZeneca’s vaccine candidate gives public health officials hope they may soon have access to a vaccine that is cheaper and easier to distribute than those of some of its rivals.

Even though the vaccine still needs regulatory approval, it’s already being made at Emergent BioSolutions’ plant in East Baltimore. The Gaithersburg-based contract drug manufacturer was named AstraZeneca’s U.S. manufacturing partner in June. The partnership was expanded in July and is now valued at $261 million.

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Altimmune Announces Submission of Investigational New Drug Application for AdCOVID™ a Single-dose Intranasal COVID-19 Vaccine; On Track to Commence Phase 1 Clinical Study in December Nasdaq:ALT

GAITHERSBURG, Md., Nov. 25, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company advancing proprietary intranasal vaccines and peptide therapeutics, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to commence a Phase 1 clinical study of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. AdCOVID is designed to stimulate a broad immune response including both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA and resident memory T cells) in the nasal cavity and respiratory tract.

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Dr. Carol Nacy, CEO of Sequella Incorporated, joins BioTalk to discuss her career, the evolution of their science, and vision for the future.

Listen now via Apple https://apple.co/374aOFI, Google https://bit.ly/3pTGqqj, Spotify https://bit.ly/3nIl7WO, and TuneIn https://bit.ly/3nIl7WO

Dr. Nacy co-founded our Sequella in 1997 and has served as our CEO and Chairman of the Board since 1999. Prior to Sequella, Dr. Nacy served during 1997 and 1998 as Chief Scientific Officer (CSO) for Anergen, Inc., a California company acquired by Corixa Corporation in December 1998. From 1993 through 1997, Dr. Nacy was Executive Vice President and CSO at EntreMed, Inc. and participated in its successful initial public offering in June 1996. Previously, Dr. Nacy was Career Scientist (GS-15) at the Walter Reed Army Institute of Research, Washington, DC. Dr. Nacy currently serves on the board of directors of companies and non-profit agencies.

Click here for the Transcript

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Johns Hopkins study shows ‘magic mushrooms’ may be effective in treating major depression – Baltimore Business Journal

Four weeks after receiving monitored doses of psilocybin, researchers reported more than half of the study’s 24 participants had achieved remission from their depression.

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