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597th Edition, February 27, 2024

By BHI Weekly News Archives

 

Empowering Change: Lance Kawaguchi’s Journey with the Cure Brain Cancer Foundation

Join us for an engaging episode of BioTalk as we sit down with Lance Kawaguchi, Chief Executive Officer of the Cure Brain Cancer Foundation. Lance’s career trajectory from global finance to non-profit leadership is as inspiring as it is impactful, driven by a personal mission to combat brain cancer following the loss of his mother.

Listen now via your favorite podcast platforms:
Apple: https://apple.co/48uln2K
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Spotify: https://spoti.fi/3IeTEIy
Amazon Music: https://amzn.to/3OVRFwE
TuneIn: https://bit.ly/2M60Wmx

In this episode, we explore Lance’s journey from senior investment banker to non-profit leader, propelled by personal loss and a vision for change. We delve into the SouthPoleTrek4Cancer initiative, spearheading a global effort to raise awareness and funds for brain and rare cancer charities, culminating in a historic journey to the South Pole. We recognize Lance’s leadership achievements, including ringing the Nasdaq bell twice as a cancer charity CEO, and his success in bringing the GBM AGILE Clinical Trial Platform from the US to Australia, accelerating breakthrough research efforts.

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BioHealth Innovation, Inc.’s Rich Bendis Named Finalist for the Community Builder Award in the 2023 BioHealth Capital Region Annual Awards

Rockville, MD – BioHealth Innovation, Inc. (BHI) is proud to announce that our Founder, President & CEO, Rich Bendis, has been named a finalist for the Community Builder Award in the 2023 BioHealth Capital Region Annual Awards, hosted by BioBuzz.

Rich Bendis’ dedication to fostering innovation and supporting the biohealth ecosystem has been instrumental in driving growth and collaboration within the industry. His visionary leadership at BHI has created a platform for emerging companies, researchers, and entrepreneurs to connect with resources, expertise, and opportunities, significantly contributing to the region’s economic development and public health advancements.

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Beyond the Breakthrough: Overcoming Georgetown’s spinout challenge

Being a university in Washington DC poses interesting challenges, but Georgetown University’s Tatiana Litvin-Vechnyak is determined to turn them into opportunities.

Weirdly, being located at the heart of the US capital doesn’t always help Georgetown University when it comes to creating spinout companies. State universities often have economic development mandates that they can follow, but in Washington DC Georgetown is in something of a vacuum — with little direction for what to focus on, less set funding and fewer people pushing to advance the technologies coming out of the institution.

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TEDCO Generates $2.7 Billion in Economic Benefits for Maryland’s Ecosystem in 2023, According to Independent Study

COLUMBIA, Md. (February 21, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced the findings of an independent economic impact study detailing the contributions of TEDCO’s six core programs to the state of Maryland. 

Conducted by the University of Baltimore’s Jacob France Institute, the study found that TEDCO continues to be a significant economic driving force in Maryland creating nearly $2.7 billion in statewide economic activity as of 2023.  TEDCO has invested in or supported the growth of a portfolio of 442 of Maryland’s leading technology companies, more than doubling the number of companies identified in the first TEDCO impact study in 2008.

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Emergent BioSolutions Appoints Industry Leader Joseph C. Papa as New President and CEO

GAITHERSBURG, Md., Feb. 21, 2024 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS), a global company providing solutions that address public health threats and delivering life-extending products to market, today announced that its Board of Directors has appointed Joseph C. Papa as president and CEO, effective February 21, 2024. Mr. Papa succeeds Haywood Miller, who will step down from his role as interim CEO, effective February 21, 2024.

“Following a thorough search process, we are pleased to appoint Joe Papa as president and CEO of Emergent,” said Zsolt Harsanyi, Ph.D., chairman of the Board of Directors. “He is a recognized industry leader with unparalleled experience in all facets of the pharmaceutical and healthcare industry. Joe has a solid track record of driving growth and successfully navigating companies through periods of transformation. His leadership will be instrumental in strengthening Emergent’s balance sheet and returning to growth, as we continue to deliver on our mission to protect and enhance life. On behalf of the Board, I would also like to thank Haywood Miller for his leadership and contributions during this interim period.”

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AstraZeneca Completes Acquisition of Gracell Biotechnologies

AstraZeneca today announced the successful completion of the acquisition of Gracell Biotechnologies Inc. (Gracell, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune diseases, furthering AstraZeneca’s cell therapy ambition.

The acquisition enriches AstraZeneca’s growing pipeline of cell therapies with GC012F, a novel, clinical-stage FasTCAR-enabled BCMA and CD19 dual-targeting autologous chimeric antigen receptor T-cell (CAR-T) therapy. GC012F is a potential new treatment for multiple myeloma, as well as other haematologic malignancies and autoimmune diseases including systemic lupus erythematosus (SLE).

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Lab Space Available at Johns Hopkins Science & Technology Park

Attention life sciences companies seeking lab space in Baltimore: Starting June 1st, a fully built-out lab/office space will be available at the Science & Technology Park at Johns Hopkins, located at 1812 Ashland Avenue. This 170,000 square foot facility is designed to accommodate companies at any stage, from startups to established firms.

The building hosts the Johns Hopkins “Fast Forward” innovation hub, promoting the advancement and commercialization of innovations. Situated within a community focused on research and development, it offers an unparalleled opportunity for companies to grow and collaborate in a leading-edge environment.

Don’t miss this chance to locate your company in a premier life sciences hub. Contact Matthew L. Seward with Cushman & Wakefield for more details.

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LABIOTECH: Biotechs in the US Capital: seven key players based in Washington DC

Washington DC: The heart of the BioHealth Capital Region

The BioHealth Capital Region (BHCR) encompasses Maryland, Virginia, and Washington D.C., and more than 1,800 life science and companies are established there. BHCR is among the top-performing biotech clusters in the U.S., with first-class educational facilities, innovative companies, and over 70 federal labs. While the area of Washington D.C. is smaller than Virginia and Maryland where companies are spread across, Washington is still a destination of choice with innovative biotech companies and events

The BHCR was ranked third biopharma cluster in the U.S. by Genetic Engineering and Biotechnology News behind the San Francisco Bay Area and the Boston/Cambridge area. The criteria to measure the performance of these hubs were the National Institutes of Health funding, venture capital funding, the number of biotechnology patents, the total lab space, and the number of jobs. This region, with Washington D.C. at its heart, is one of the most dynamic in the biotech industry.

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Biden-Harris Administration’s ARPA-H commits $100 million to accelerate women’s health research

First Lady Jill Biden announces funding as first major deliverable from new White House Initiative on Women’s Health Research 

As the first major deliverable of the White House Initiative on Women’s Health Research, the Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced the ARPA-H Sprint for Women’s Health, which commits $100 million towards transformative research and development in women’s health. ARPA-H, which was created in 2022 as part of President Biden’s bipartisan Unity Agenda, seeks to advance and accelerate health solutions. 

 

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Three Congressional Letters Show the March-In Debate Has Shifted

When the Biden Administration unleashed its proposed march-in guidelines last December, it claimed they would be a powerful tool for lowering drug prices by allowing the government to “march in” to license copiers under the authorities of the Bayh-Dole Act.

It did so despite previously joining every other Administration denying price control petitions as not authorized under the law. It should have known the proposal would have minimal impact on drug prices—but would have a devastating impact on American innovation. That’s because the guidelines apply to all federal R&D agencies—not just the National Institutes of Health — so they cover inventions across the spectrum, not just the life sciences.

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596th Edition, February 21, 2024

By BHI Weekly News Archives

 

WBJ: New CEO at Children’s National lays out her vision

By Sara Gilgore – Staff Reporter, Washington Business Journal – 

It was her mother’s 86th birthday when Michelle Riley-Brown received a call that would change the trajectory of her career.

Holding the phone to her ear in her Houston home on March 3, 2023, the veteran health executive learned she was not only the first woman — but the first African American woman — to be named president and CEO of Children’s National Hospital in D.C.

The New Orleans native and youngest of five siblings — four of whom went into health care — immediately thought of her late father, a general surgeon who dedicated his life to medicine.

 

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BioHealth Innovation, Inc.’s Rich Bendis Named Finalist for the Community Builder Award in the 2023 BioHealth Capital Region Annual Awards

Rockville, MD – BioHealth Innovation, Inc. (BHI) is proud to announce that our Founder, President & CEO, Rich Bendis, has been named a finalist for the Community Builder Award in the 2023 BioHealth Capital Region Annual Awards, hosted by BioBuzz.

Rich Bendis’ dedication to fostering innovation and supporting the biohealth ecosystem has been instrumental in driving growth and collaboration within the industry. His visionary leadership at BHI has created a platform for emerging companies, researchers, and entrepreneurs to connect with resources, expertise, and opportunities, significantly contributing to the region’s economic development and public health advancements.

Read More

 
Emergent BioSolutions Appoints Industry Leader Joseph C. Papa as New President and CEO

GAITHERSBURG, Md., Feb. 21, 2024 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS), a global company providing solutions that address public health threats and delivering life-extending products to market, today announced that its Board of Directors has appointed Joseph C. Papa as president and CEO, effective February 21, 2024. Mr. Papa succeeds Haywood Miller, who will step down from his role as interim CEO, effective February 21, 2024.

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Fierce Biotech: NIH to invest another $515M over 4 years for long COVID research

The National Institutes of Health is investing $515 million more into long COVID research efforts, three years after launching the initiative with $1.15 billion.

The cash infusion for the Recover program, announced Tuesday, will bolster ongoing research into the underlying biology and potential treatments for long COVID. NIH Director Monica Bertagnolli, M.D., said in a release that nearly 90,000 people were participating in ongoing Recover observational trials across more than 300 sites. 

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Waisman Biomanufacturing and RoosterBio Announce Collaboration for GMP Manufacturing of Cell and Exosome Therapies

FREDERICK, Md., Feb. 13, 2024 /PRNewswire-PRWeb/ — Waisman Biomanufacturing, a leading contract development and manufacturing organization (CDMO) which is strategically part of the University of Wisconsin Madison, announced today a strategic partnership with RoosterBio, Inc., a leading provider of human mesenchymal stem/stromal cells (MSCs), highly engineered media solutions, and bioprocess development services.

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Children’s National performs first ever HIFU procedure on patient with cerebral palsy

In January, a team of multidisciplinary doctors performed the first case in the world of using bilateral high intensity focused ultrasound (HIFU) pallidotomy on Jesus, a 22-year-old patient with dyskinetic cerebral palsy.

The procedure is part of a clinical trial led by Chima Oluigbo, M.D., pediatric neurosurgeon at Children’s National Hospital.

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Career Opportunity with BHI: Life Sciences Business Strategist

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia). We are seeking an entry-level Life Sciences Business Strategist to join our team remotely.

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TEDCO Generates $2.7 Billion in Economic Benefits for Maryland’s Ecosystem in 2023, According to Independent Study

COLUMBIA, Md. (February 21, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced the findings of an independent economic impact study detailing the contributions of TEDCO’s six core programs to the state of Maryland. 

Conducted by the University of Baltimore’s Jacob France Institute, the study found that TEDCO continues to be a significant economic driving force in Maryland creating nearly $2.7 billion in statewide economic activity as of 2023.  TEDCO has invested in or supported the growth of a portfolio of 442 of Maryland’s leading technology companies, more than doubling the number of companies identified in the first TEDCO impact study in 2008.

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595th Edition, February 13, 2024

By BHI Weekly News Archives

 

BHI Remembers Dr. William G. Hearl: A Pillar of the BioHealth Capital Region

BioHealth Innovation (BHI) deeply mourns the loss of Dr. William G. Hearl, a former BHI Board member and a prominent contributor to the BioHealth Capital Region. Rich Bendis, BHI’s President and CEO, shared, “Bill’s unwavering commitment and leadership in our region have been instrumental to its growth. His dedication to fostering innovation and supporting emerging entrepreneurs and the biotech community was truly remarkable. We have lost not just a great leader but a friend who inspired many.” Our heartfelt condolences go out to his family, friends, and colleagues at Immunomic Therapeutics. To read more about Dr. Hearl’s legacy, visit https://www.immunomix.com/in-loving-memory-dr-william-g-hearl-immunomic-therapeutics-founder/

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Career Opportunity with BHI: Life Sciences Business Strategist

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia). We are seeking an entry-level Life Sciences Business Strategist to join our team remotely.

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Amarex Celebrates Its 25th Anniversary

Germantown, MD, USA (February 07, 2024) – Amarex Clinical Research, LLC, an NSF company, announces December 2023 marked its 25th year advancing patient access to safe and effective clinical products through delivery of outstanding regulatory and clinical trial services to Sponsors within the life sciences industry.

Amarex was founded in 1998 by scientists from diverse backgrounds in academia, industry, and the FDA. Born from a vision of wanting better services from CRO vendors by correcting the many inefficiencies and deficiencies in the management and conduct of clinical trials, our founders revisited the clinical trial process and developed improved, cost-effective methods for clinical product development without sacrificing quality. Amarex’s unmatched value to Sponsors continues to differentiate Amarex from the competition by assigning senior level staff to every project, optimizing time and cost with efficient and effective processes and procedures, building true collaborative partnerships with Sponsors, and through a commitment to long-term client relationships in order to achieve successful clinical development program outcomes.

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I-Mab Signs Agreement to Divest its Assets and Business Operations in China to Become Rockville-Based Biotech

ROCKVILLE, Md., Feb. 7, 2024 /PRNewswire/ —  I-Mab (the “Company“) (NASDAQ: IMAB), a global biotech company exclusively focused on bringing highly differentiated immunotherapies and biologics for cancer treatment to patients around the world, today announced that as part of its strategy to become a U.S.-based biotech, its Chinese subsidiaries have entered into definitive agreements with I-Mab Biopharma (Hangzhou) Co., Ltd. (the “Hangzhou Company“), an unconsolidated affiliate of the Company, and a group of China-based investors to divest the Company’s assets and business operations in China.

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CEL-SCI Announces Pricing of $7.75 Million Public Offering of Common Stock

VIENNA, Va.–()–CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of an offering of 3,875,000 shares of its common stock at an offering price of $2.00 per share, for gross proceeds of $7.75 million, before deducting underwriting discounts and offering expenses. All of the shares of common stock are being offered by the Company. The offering is expected to close on February 13, 2024, subject to satisfaction of customary closing conditions.

The Company intends to use the net proceeds from this offering to fund the continued development of Multikine*, for general corporate purposes, and working capital.

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Children’s National Event: Navigating from Research to Market Approval: The AGAMREE Journey

Join Children’s National Hospital for a pivotal symposium on the journey of AGAMREE® from academic research to market approval for DMD treatment in children. This event highlights the critical role of academic entrepreneurship and collaboration with industry in advancing treatments for rare diseases. Featuring insights from experts on the Vamorolone drug development program, regulatory pathways, and the venture philanthropy business model, this symposium is for those committed to making a difference in the biotech and healthcare sectors. Don’t miss this opportunity to engage, learn, and network with leaders in the field.

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594th Edition, February 6, 2024

By BHI Weekly News Archives

 

BioHealth Innovation, Inc. (BHI) Welcomes Yaminah Leggett-Wells, Senior Director, Alliance Management at Amgen as Newest Member of the Board of Directors

ROCKVILLE, MARYLAND, February 5, 2024 – BioHealth Innovation, Inc. (BHI), a leading public-private nonprofit organization dedicated to advancing healthcare innovation in the BioHealth Capital Region, proudly announces the appointment of Yaminah Leggett-Wells to its esteemed Board of Directors.

Yaminah Leggett-Wells serves as the Senior Director of Alliance Management at Amgen, overseeing global partnerships spanning all stages of drug development. With over 20 years of experience in the pharmaceutical industry, her expertise includes strategic leadership, clinical operations, business development, and project and alliance management.

Yaminah Leggett-Wells’ appointment to the BHI Board of Directors is a significant addition who brings valuable skills and experience to our organization,” remarked Richard Bendis, President and CEO of BHI. “Her extensive pharmaceutical industry background and commitment to our region make her an outstanding asset to our Board and our mission in the BioHealth Capital Region.”

Yaminah joined Amgen in 2023 following Amgen’s acquisition of Horizon Therapeutics. Prior to this, she played instrumental roles in the development of medicines for asthma and neuromyelitis optica spectrum disorder at AstraZeneca and Viela Bio, demonstrating her in-depth knowledge of drug development and regulatory affairs.

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Maxim Biomedical, Inc. Secures Second NIH RADx Tech High Performance Award for Continued Development of At-Home FiarFly™ Reader and COVID-19 & Flu A/B Rapid Test

ROCKVILLE, Md., Feb. 1, 2024 /PRNewswire/ — MaximBio, a leading innovator in next-generation healthcare diagnostic technologies, is pleased to announce that it has been granted a second follow-on award from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program for the continued development of its revolutionary FiarFly™ reader and COVID-19 & Flu A/B multiplex test. This additional Phase 2 award, totaling approximately $4.4 million, will be used to accelerate the development of the FiarFly™ reader and COVID-19 & Flu A/B multiplex test and quickly prepare for clinical trials targeting this influenza season.

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WBJ: AstraZeneca doubles down on Montgomery County with $300M investment

By Sara Gilgore – Staff Reporter, Washington Business Journal – AstraZeneca PLC (NYSE: AZN) is leaving no doubt about its commitment to Montgomery County, pouring $300 million into a new U.S. manufacturing hub it’s establishing in Rockville just a couple months after taking over another building nearby.

The British pharmaceutical giant said Tuesday the facility at 9950 Medical Center Drive will start out as a space to make T-cell therapies for clinical trials in cancer, and could support other disease areas and commercial work going forward. The company also said it expects to create more than 150 new jobs at the site.

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GEN: Novo Holdings Buys Catalent for $16.5B; Sells Three Sites to Novo Nordisk for $11B

By Alex Philippidis -February 5, 2024 – Novo Holdings, the asset manager of the foundation that controls Novo Nordisk, has agreed to acquire contract development and manufacturing organization (CDMO) Catalent for $16.5 billion—with the buyer standing to recoup two-thirds of that expense by selling three of Catalent’s fill-finish sites to Novo Nordisk for $11 billion upfront so it can meet booming demand for its blockbuster obesity drugs Wegovy® and diabetes drug Ozempic®, the companies said today.

The three sites—consisting of facilities in Bloomington, IN; Brussels, Belgium; and Anagni, Italy—employ more than 3,000 people combined, about one sixth of Catalent’s total global workforce of more than 18,000 people, including 3,000 scientists and technicians.

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Baltimore’s LifeSprout Enters into Licensing Agreement with Boyang Trading to Develop and Commercialize Next-Generation Lumina™ Dermal Filler in Greater China

BALTIMORE, Jan. 31, 2024 /PRNewswire/ — LifeSprout, a privately held regenerative medicine company founded with technology licensed from Johns Hopkins University, today announced it has entered into a definitive agreement with Boyang Trading Co., Ltd. to exclusively develop and commercialize the Lumina™ dermal filler in mainland China, Hong Kong, Macau, and Taiwan.

Lumina is the first product from LifeSprout’s proprietary Regenerative Matrix platform. The technology comprises biomimetic, biocompatible, biodegradable materials engineered to look and feel like native soft tissue.

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Revolo Biotherapeutics Receives Orphan Drug Designation from the U.S. FDA for its First-in-Class Peptide as a Potential Treatment for Eosinophilic Esophagitis

GAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Jan. 30, 2024 (GLOBE NEWSWIRE) — Revolo Biotherapeutics (“Revolo” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.

The FDA grants ODD status to support the development and evaluation of potential new medicines intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Revolo believes that this ODD reflects the potential for ‘1104 to address a critical unmet need for people living with EoE.

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MaxCyte and Wugen Sign Strategic Platform License to Expedite Scale-Up of Clinical and Commercial Manufacturing of Wugen’s Investigational Allogeneic, Off-the-Shelf Cell Therapies for Cancers

ROCKVILLE, Md. and ST. LOUIS, Jan. 30, 2024 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, and Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced the signing of a strategic platform license (SPL).

Under the terms of the agreement, Wugen gains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte will receive annual license fees and program-related revenue.

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FDA Grants Orphan Drug Designation (ODD) Status to NeoImmuneTech’s NT-I7 for Advanced Pancreatic Cancer Treatment

ROCKVILLE, Md., Jan. 30, 2024 /PRNewswire/ — NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer.[3]

Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the third deadliest cancer in the US and European Union with a combined annual mortality of 139,000.[1],[4] Advanced pancreatic cancer has a five-year relative-survival-rate of 3%. Pancreatic cancer has been labeled as a “silent killer” because it is normally asymptomatic in the early stages which implies that it is often diagnosed at a late stage when tumors are highly resistant to treatment modalities. This underscores the critical need for new and more effective therapeutic approaches.2

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BioBuzz: Virginia Bio-Connect – The Success of Virginia’s First Statewide Collaborative Life Sciences Initiative

By Jelena Ivanjac | January 30, 2024 – The end of 2023 marked the completion of Virginia’s first statewide life sciences initiative, Virginia Bio-Connect, which started in April 2021. This comprehensive industry cluster strengthening project, supported by Virginia Growth and Opportunity Foundation funding and led by the Virginia Biotechnology Association, engaged thousands of life sciences professionals and hundreds of organizations and companies within the sector with the overarching goal of fostering a more connected life sciences ecosystem, providing support for early-stage companies, and driving workforce development throughout the state.

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Bio: House passes bill restoring full R&D expensing

On January 31, the House passed legislation to restore the immediate expensing of R&D expenses. The Biotechnology Innovation Organization (BIO) has long advocated for this change.

Until 2022, research and development expenses were 100% tax deductible each year. However, the Tax Cuts and Jobs Act of 2017 required companies to amortize domestic expenditures over five years, and international expenditures over 15 years.

The $78 billion Tax Relief for American Families and Workers Act, passed yesterday, would reverse the change and reinstate R&D expensing. R&D expenses would be 100% deductible through 2025.

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BioHealth Innovation Insights from the 2024 J.P. Morgan Healthcare Conference

BioHealth Innovation (BHI) was prominently represented at the 2024 J.P. Morgan Healthcare Conference, with several Entrepreneurs-in-Residence (EIRs) in attendance. The insights gathered by these experienced professionals provide a comprehensive view of the current trends, challenges, and opportunities in the biohealth industry. Here’s a summary of their observations and thoughts.

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GEN: Top 10 Biopharma Takeover Targets of 2024

By Alex Philippidis – Viewed simply by numbers of merger and acquisition (M&A) deals, 2023 was a down year: 1,078 biotech companies found buyers last year, down from 1,088 in 2022, while the number of pharma companies carrying out buyouts fell more significantly, from 778 two years ago to 679.

These numbers come from LSEG, the global financial markets infrastructure and data provider that owns the London Stock Exchange. LSEG’s data also reveals marked increases in the dollar values assigned to the biotech companies and pharma companies that are being acquired. The total value of biotech M&A in 2023 stood at $122.2 billion, up 45% from $84.2 billion a year earlier. The total value of pharma M&A jumped 38% year over year, from $98.5 billion in 2022 to $135.5 billion in 2023.

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Deadline Approaching: Apply to Be Part of the Maryland Delegation at BIO 2024

The Maryland Department of Commerce invites companies to seize the opportunity to join the Maryland delegation at the BIO International Convention in San Diego, CA, this June 3-6, 2024. This event offers unparalleled networking, learning, and visibility for companies in the biotech sector.

Benefit from a complimentary Premier Access pass, which includes access to key partnering sessions, exhibitor booths, educational content, and exclusive networking receptions. Your company will also gain promotional exposure as part of the delegation.

To be eligible, companies must be registered and in good standing in Maryland. Selected companies are expected to actively participate in pre-conference and event activities, and share insights post-event.

Applications are due by February 21, 2024. Click here to apply now. For queries, contact life.sciences@maryland.gov. This is a valuable opportunity to showcase your company on a global stage. Apply now to join the Maryland delegation at BIO 2024.

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Infinity Bio Launches Next-Generation Antibody Profiling Platform Utilizing MIPSA Technology

BALTIMORE–()–Infinity Bio, Inc. announces its new antibody profiling platform, leveraging Molecular Indexing of Proteins by Self-Assembly (MIPSA) technology. This platform offers unparalleled depth in immune system analysis, advancing immunology, virology, autoimmunity, and allergy research, providing new disease insights, and discovering new biomarkers and treatments. The MIPSA technology exploits recent advances in high throughput DNA sequencing and DNA synthesis, to create and analyze the most complete panels of immune targets available.

The immune system crafts antibodies from approximately one quadrillion options, enabling it to identify and neutralize any infectious threat. However, flaws in the immune system can result in excessive inflammation, autoimmunity, or allergies. Infinity Bio’s scientists have developed a novel technique, MIPSA, to examine the extensive array of antibodies present in blood or other fluid, providing comprehensive understanding of individual immune responses.

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593rd Edition, January 30, 2024

By BHI Weekly News Archives

 

Technical.ly: ETC, One of Baltimore’s Oldest Entrepreneurship Incubators, Names Arti Santhanam as New Executive Director

After a period of leadership transition and strategic planning, the organizations behind one of Baltimore’s longest-standing entrepreneurial communities have appointed a new executive director to take it to the next level.

On Tuesday, the Baltimore Development Corporation (BDC) and Maryland Technology Development Corporation (TEDCO) jointly announced the appointment of Arti Santhanam as the new executive director of the Emerging Technology Centers (ETC Baltimore).

Santhanam most recently served as executive director of TEDCO’s Maryland Innovation Initiative (MII), a public-private effort to promote academic research commercialization across the state.

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First Patient Enrolled in Rockville’s Rise Therapeutics’ Rheumatoid Arthritis Clinical Trial

ROCKVILLE, Md., Jan. 29, 2024 /PRNewswire/ — Rise Therapeutics, a clinical-stage biotechnology company developing novel oral immunotherapeutic medicines, today announced that it has enrolled its first patient in its R-2487 Phase 1 rheumatoid arthritis clinical trial.

“This is an important milestone for the company and patients suffering from rheumatoid arthritis” states Gary Fanger President and Chief Executive Officer of Rise Therapeutics. “This achievement reinforces our commitment to deliver innovative new medicines to the clinical community.”

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BioHealth Innovation, Inc.’s Rich Bendis Named Finalist for the Community Builder Award in the 2023 BioHealth Capital Region Annual Awards

Rockville, MD – BioHealth Innovation, Inc. (BHI) is proud to announce that our Founder, President & CEO, Rich Bendis, has been named a finalist for the Community Builder Award in the 2023 BioHealth Capital Region Annual Awards, hosted by BioBuzz.

Rich Bendis’ dedication to fostering innovation and supporting the biohealth ecosystem has been instrumental in driving growth and collaboration within the industry. His visionary leadership at BHI has created a platform for emerging companies, researchers, and entrepreneurs to connect with resources, expertise, and opportunities, significantly contributing to the region’s economic development and public health advancements.

BioBuzz’s recognition of Rich Bendis as a finalist for the Community Builder Award is a testament to his unwavering commitment and impactful work in the BioHealth Capital Region, encompassing Maryland, Washington, DC, and Virginia.

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MaxCyte Signs Strategic Platform License with Imugene to Advance their Cancer Immunotherapy Programs

ROCKVILLE, Md., and SYDNEY, Australia, Jan. 23, 2024 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, and Imugene, (ASX: IMU), a clinical-stage immuno-oncology and cell therapy company developing a range of new treatments that seek to activate the immune system of cancer patients to identify and eradicate tumors, today announced the signing of a strategic platform license (SPL).

Under the terms of the agreement, Imugene obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related revenue.

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QIAGEN announces partnership with Penn State University to advance microbiome sciences

Germantown, Maryland, and State College, Pennsylvania, Jan. 25, 2024 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a first-in-kind collaboration with Penn State University in the United States to create a shared research and education facility for the fast-developing microbiome sciences.

The university-industry partnership will serve as a beacon for this field by investigating research opportunities that address challenges and research gaps facing the microbiome, which involves the research into a community of microorganisms that can be found living together in any given environment, including the human body.

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Calling all MedTech innovators: Up to $100,000 in federal grants to be awarded

Application deadline is Feb. 15 for the pandemic network edition of “Make Your Medical Device Pitch for Kids!™

WASHINGTON, Jan. 29, 2024 (GLOBE NEWSWIRE) — The Alliance for Pediatric Device Innovation (APDI) and Pediatric Pandemic Network (PPN) have teamed up to provide a unique opportunity for innovators of pediatric medical devices, diagnostics and digital health solutions. The organizations are inviting submissions for a pitch competition that emphasizes the development of medical countermeasures (MCMs) – innovations designed to address the unique healthcare needs of children during pandemics and other disasters. MCMs play a pivotal role in bolstering readiness and response capabilities to disasters arising from a broad spectrum of threats.

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PQE Group: 100+M€ In Revenues, Expansion In Emerging Markets and Business Lines

Florence, Jan. 26, 2024  PQE Group, the renowned Life Science consulting powerhouse, concludes the fiscal year 2023 with a 10% growth and an upwardly revised income exceeding 100 million euros in revenues. The Italian headquartered global firm, celebrated as a preferred advisor to pharma manufacturing and medical device corporations and SMEs globally, marks this success as a testament to its resilience, adaptability, and strategic vision amid the complex global landscape.

At a time when many companies grapple with geopolitical challenges, crises, and inflation rates, PQE Group stands out not only for its resilience but for its ability to thrive in uncertain times, showcasing positive growth across all financial indicators,” stateGilda D’Incerti, CEO & Founder of PQE Group. “This success is rooted in meticulous planning, strategic investments in cutting-edge technologies, and a corporate culture that values agility and innovation.”

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Haystack Oncology and TriSalus Life Sciences Enter Research Collaboration

BALTIMORE, Jan. 22, 2024 /PRNewswire/ — Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company and developer of best-in-class personalized MRD technology (Haystack MRD™), has entered a research collaboration with TriSalus Life Sciences to evaluate therapeutic response and provide molecular insights in connection with the clinical development of TriSalus’ SD-101, an investigational class C toll-like receptor-9 (TLR9) agonist. SD-101 is delivered via hepatic arterial infusion or pancreatic retrograde venous infusion in their phase 1 and 1b clinical trials using their proprietary Pressure-Enabled Drug Delivery™ (PEDD™) to overcome the challenges associated with intratumoral pressure for patients diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and pancreatic adenocarcinoma.

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The Daily Record: New Johns Hopkins institute aims to make Baltimore an AI hub

Johns Hopkins University has launched an ambitious endeavor that the school’s leaders say will make Baltimore a hub of the booming artificial intelligence industry.

The new Data Science and Translation Institute, announced several months ago and planned for the western edge of the Homewood Campus, is expected to be “the leading academic hub for data science and artificial intelligence – a resource that will bring world-class experts to the Baltimore region and drive game-changing innovations,” said Rama Chellappa, interim co-director of the planned institute and a Bloomberg Distinguished Professor at the school.

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REGENXBIO Announces Positive Interim Data from Phase II AAVIATE® Trial of ABBV-RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery

ROCKVILLE, Md., Jan. 16, 2024 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced positive interim data from the Phase II AAVIATE® trial of ABBV-RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using suprachoroidal delivery. Wet AMD is a chronic, life-long disease with available anti-VEGF treatment options that may reduce the risk of blindness, but require frequent injections. Investigational ABBV-RGX-314 using suprachoroidal delivery is designed to be a one-time, in office treatment that has the potential to sustain constant anti-VEGF therapy and stabilize or improve vision long-term for wet AMD patients. The new data presented at the Hawaiian Eye and Retina meeting in Maui, HI by John Pitcher, M.D., Eye Associates of New Mexico, includes 6-month results from two additional dose level 3 cohorts (Cohorts 5 and 6). ABBV-RGX-314, being developed in collaboration with AbbVie, is also being investigated as a potential one-time gene therapy for the treatment of diabetic retinopathy and other chronic retinal conditions.  

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propagenix

592nd Edition, January 23, 2024

By BHI Weekly News Archives

 

 

STEMCELL Technologies Announces Acquisition of Gaithersburg’s Propagenix Inc.

VANCOUVER, British Columbia–()–STEMCELL Technologies, Canada’s largest biotechnology company, is pleased to announce the acquisition of Propagenix Inc.—a Maryland-based biotechnology company focused on developing technologies to enable new approaches in regenerative medicine.

“The acquisition of Propagenix is an important step in STEMCELL’s growth journey and an achievement for Canada’s biotechnology industry,” said Dr. Allen Eaves, President and CEO, STEMCELL. “Propagenix’s technology has the potential to contribute to big advancements in scientific research in both labs and clinical settings for the treatment of cancer, airway diseases, and other disorders, and we are thrilled to welcome its portfolio into STEMCELL’s product suite.”

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BioHealth Innovation Insights from the 2024 J.P. Morgan Healthcare Conference

BioHealth Innovation (BHI) was prominently represented at the 2024 J.P. Morgan Healthcare Conference, with several Entrepreneurs-in-Residence (EIRs) in attendance. The insights gathered by these experienced professionals provide a comprehensive view of the current trends, challenges, and opportunities in the biohealth industry. Here’s a summary of their observations and thoughts.

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REGENXBIO Announces Positive Interim Data from Phase II AAVIATE® Trial of ABBV-RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery

ROCKVILLE, Md., Jan. 16, 2024 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced positive interim data from the Phase II AAVIATE® trial of ABBV-RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using suprachoroidal delivery. Wet AMD is a chronic, life-long disease with available anti-VEGF treatment options that may reduce the risk of blindness, but require frequent injections. Investigational ABBV-RGX-314 using suprachoroidal delivery is designed to be a one-time, in office treatment that has the potential to sustain constant anti-VEGF therapy and stabilize or improve vision long-term for wet AMD patients. The new data presented at the Hawaiian Eye and Retina meeting in Maui, HI by John Pitcher, M.D., Eye Associates of New Mexico, includes 6-month results from two additional dose level 3 cohorts (Cohorts 5 and 6). ABBV-RGX-314, being developed in collaboration with AbbVie, is also being investigated as a potential one-time gene therapy for the treatment of diabetic retinopathy and other chronic retinal conditions.            

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UMB Researchers Aim to Enhance Vaccines with $9.4M NIH Grant

January 16, 2024  –  By Laura Lee – Principal Investigator Robert K. Ernst, PhD, the Dr. Paul and Mrs. Jean Corcoran Endowed Professor and chair of the Department of Microbial Pathogenesis at the University of Maryland School of Dentistry (UMSOD) and Distinguished University Professor, has been awarded a five-year, $9.4 million contract from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) to continue work developing and testing novel adjuvants for the improvement of vaccines. Ernst was awarded $6.4 million in funding through the same NIAID program in 2018, bringing his total funding for adjuvant development to over $16 million.

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Virginia Catalyst Announces Grant Round 15 Awarded Projects

The Virginia Catalyst, also known as the Virginia Biosciences Health Research Corporation (VBHRC), today announced that it has awarded $2.2 million in grants to four life and bioscience projects in the Commonwealth of Virginia. These four collaborative projects, involving Virginia research universities and industry partners, were awarded through Virginia Catalyst Grant Round 15 to address major unmet healthcare needs and drive job creation and capital formation in Virginia.

Through this 15th round of funding, Virginia Catalyst has awarded 61 grants totaling $29.7 million, resulting in over $47 million in matching funds and an additional $821 million in follow-on funding to date.

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BioHealth Innovation, Inc. (BHI) Welcomes Peter Ronco as a New Member of the Board of Directors

ROCKVILLE, MARYLAND, January 16, 2024– BioHealth Innovation, Inc. (BHI), a leading public-private non-profit organization dedicated to advancing healthcare innovation in the BioHealth Capital Region, is pleased to announce the appointment of Peter Ronco to its Board of Directors.

Peter Ronco is an accomplished drug developer and innovative senior pharmaceutical executive, currently serving as the Chief Executive Officer of Emmes, a full-service Contract Research Organization (CRO) operating in 30+ countries and across multiple disease areas, including ophthalmology, vaccines, rare diseases, cell & gene therapy, and neuroscience. With extensive global experience spanning therapeutic areas such as oncology, immunology, neuroscience, vaccines, anti-infectives, cardiovascular, and retinal gene therapy, Peter brings a wealth of knowledge and expertise to the BHI Board.

As CEO of Emmes, Peter is responsible for setting the strategic direction and the organization’s day-to-day operations, which collaborates with over 210 sponsors, including pharmaceutical and biotech companies, government agencies, academic institutions, and non-profit foundations.

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Peter Ronco

591st Edition, January 17, 2024

By BHI Weekly News Archives

 

BioHealth Innovation, Inc. (BHI) Welcomes Peter Ronco as a New Member of the Board of Directors

ROCKVILLE, MARYLAND, January 16, 2024– BioHealth Innovation, Inc. (BHI), a leading public-private non-profit organization dedicated to advancing healthcare innovation in the BioHealth Capital Region, is pleased to announce the appointment of Peter Ronco to its Board of Directors.

Peter Ronco is an accomplished drug developer and innovative senior pharmaceutical executive, currently serving as the Chief Executive Officer of Emmes, a full-service Contract Research Organization (CRO) operating in 30+ countries and across multiple disease areas, including ophthalmology, vaccines, rare diseases, cell & gene therapy, and neuroscience. With extensive global experience spanning therapeutic areas such as oncology, immunology, neuroscience, vaccines, anti-infectives, cardiovascular, and retinal gene therapy, Peter brings a wealth of knowledge and expertise to the BHI Board.

As CEO of Emmes, Peter is responsible for setting the strategic direction and the organization’s day-to-day operations, which collaborates with over 210 sponsors, including pharmaceutical and biotech companies, government agencies, academic institutions, and non-profit foundations.

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Creation of the Emmes Group Will Advance Company’s 47-year Legacy and Build Clinical Research Infrastructure for the Future
  • New Business Unit Veridix AI Launched to Embed Technology and AI in Day-to-Day Clinical Operations
  • Dr. Rama Kondru to Join the Emmes Group as CEO, Veridix AI
  • Industry Leader Matthew Holt to Join Board of Directors

SAN FRANCISCO, Jan. 9, 2024 /PRNewswire/ — Emmes today announced the creation of the Emmes Group, with Sastry Chilukuri serving as its executive chairman and chief executive officer. The company also announced a new board member, Matthew Holt.

The Emmes Group will have two business units: Emmes, its Clinical Research Organization (CRO) led by Peter Ronco, and Veridix AI, the newly launched technology and artificial intelligence (AI) group, led by recently appointed executive Dr. Rama Kondru.

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BioHealth Innovation Insights from the 2024 J.P. Morgan Healthcare Conference

BioHealth Innovation (BHI) was prominently represented at the 2024 J.P. Morgan Healthcare Conference, with several Entrepreneurs-in-Residence (EIRs) in attendance. The insights gathered by these experienced professionals provide a comprehensive view of the current trends, challenges, and opportunities in the biohealth industry. Here’s a summary of their observations and thoughts.

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Emergent BioSolutions Awarded Procurement Contract Valued up to $235.8 Million to Supply BioThrax® (Anthrax Vaccine Adsorbed) to the U.S. Department of Defense

GAITHERSBURG, Md., Jan. 11, 2024 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has secured an indefinite-delivery, indefinite-quantity (IDIQ) procurement contract with a maximum value up to $235.8 million to supply BioThrax® (Anthrax Vaccine Adsorbed) for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease. The new contract with the U.S. Department of Defense (DoD) and led by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, is comprised of a five-year base agreement ending on September 30, 2028, and an additional five-year option that would extend the contract to September 30, 2033. 

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Research and development (R&D) that will contribute toward Advanced Research Projects Agency for Health (ARPA-H) mission needs and Small Business Innovation Research (SBIR) program objectives.

The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals from small business concerns that possess the research and development (R&D) expertise to conduct innovative research that will contribute toward ARPA-H mission needs and Small Business Innovation Research (SBIR) program objectives.

SOLICITATION 75N91024R00006 is anticipated to be made available on or about January 23, 2024 through SAM.gov.  This solicitation is anticipated to have a closing date of February 22, 2024 for receipt of proposals.

The purposes of the SBIR program are to: (a) stimulate technological innovation; (b) strengthen the role of small business in meeting Federal research/research & development (R/R&D) needs; (c) foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns; and (d) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth. 

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Children’s National Novel AI platform matches cardiologists in detecting rheumatic heart disease

WASHINGTON, D.C., Jan. 16, 2024 (GLOBE NEWSWIRE) — Artificial intelligence (AI) has the potential to detect rheumatic heart disease (RHD) with the same accuracy as a cardiologist, according to new research demonstrating how sophisticated deep learning technology can be applied to this disease of inequity. The work could prevent hundreds of thousands of unnecessary deaths around the world annually. 

Developed at Children’s National Hospital and detailed in the latest edition of the Journal of the American Heart Association, the new AI system combines the power of novel ultrasound probes with portable electronic devices installed with algorithms capable of diagnosing RHD on echocardiogram. Distributing these devices could allow healthcare workers, without specialized medical degrees, to carry technology that could detect RHD in regions where it remains endemic. 

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Precigen Receives Orphan Drug Designation for PRGN-2012 for the Treatment of Recurrent Respiratory Papillomatosis from the European Commission

GERMANTOWN, Md., Jan. 16, 2024 /PRNewswire/ — Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the European Commission (EC) has granted Orphan Drug Designation for the Company’s first-in-class investigational medicine PRGN-2012 for the treatment of recurrent respiratory papillomatosis (RRP). RRP is a rare, difficult-to-treat and sometimes fatal neoplastic disease of the upper and lower respiratory tracts caused by human papillomavirus type 6 (HPV 6) or HPV type 11 (HPV 11). PRGN-2012 received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and Precigen was the first company to receive Breakthrough Therapy Designation and an accelerated approval pathway from the FDA for an RRP treatment.

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REGENXBIO Announces Positive Interim Data from Phase II AAVIATE® Trial of ABBV-RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery

ROCKVILLE, Md., Jan. 16, 2024 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced positive interim data from the Phase II AAVIATE® trial of ABBV-RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using suprachoroidal delivery. Wet AMD is a chronic, life-long disease with available anti-VEGF treatment options that may reduce the risk of blindness, but require frequent injections. Investigational ABBV-RGX-314 using suprachoroidal delivery is designed to be a one-time, in office treatment that has the potential to sustain constant anti-VEGF therapy and stabilize or improve vision long-term for wet AMD patients. The new data presented at the Hawaiian Eye and Retina meeting in Maui, HI by John Pitcher, M.D., Eye Associates of New Mexico, includes 6-month results from two additional dose level 3 cohorts (Cohorts 5 and 6). ABBV-RGX-314, being developed in collaboration with AbbVie, is also being investigated as a potential one-time gene therapy for the treatment of diabetic retinopathy and other chronic retinal conditions.    

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Rockville’s NeoImmuneTech Welcomes a New President for its Development and Business

ROCKVILLE, Md., Jan. 15, 2024 /PRNewswire/ — NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today announces the appointment of Luke Oh, Ph.D., as President, effective immediately.

Dr. Oh is an expert in regulatory policies and drug development, encompassing both biologics and small molecules. He brings over six years of regulatory experience at the U.S. FDA. His recent tenure at Samsung Bioepis as Vice-President in charge of Regulatory Development was marked by the successful preparation and submission of seven biosimilar applications to regulatory agencies in the US, EU, UK, and Canada. Prior to this position, he has worked as Senior Staff Fellow at the U.S. FDA Division of Clinical Pharmacology III and Division of Inflammation and Immune Pharmacology, and he has held various roles in research and development for leading organizations such as Mallinckrodt Pharmaceuticals, Human Genome Sciences, and Vertex Pharmaceuticals. Dr. Oh has a Ph.D. in Neuroimmunology from the McGill University (Montreal, Canada).

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GSK Enters Agreement to Acquire Aiolos Bio
  • Acquisition expands GSK’s respiratory pipeline adding AIO-001, a phase II-ready, long-acting antibody targeting the clinically validated TSLP pathway
  • AIO-001 could redefine the standard-of-care with dosing every six months
  • AIO-001 has potential to expand GSK’s respiratory biologics portfolio to reach a broader portion of asthma patients

SAN FRANCISCO & LONDON–()–GSK plc (LSE/NYSE: GSK) and Aiolos Bio, Inc. (Aiolos) today announced that they have entered into an agreement under which GSK will acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with certain respiratory and inflammatory conditions, for a $1 billion upfront payment and up to $400 million in certain success-based regulatory milestone payments.

The acquisition provides GSK with access to Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the treatment of adult patients with asthma, with potential for additional indications including chronic rhinosinusitis with nasal polyps. AIO-001 was exclusively licensed to Aiolos outside of Greater China by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui).

Tony Wood, Chief Scientific Officer, GSK, said: “We have a proud heritage and deep development expertise in respiratory medicines, especially addressing diseases driven by IL-5 with high levels of eosinophils or high T2 inflammation. Adding AIO-001, a potentially best-in-class medicine targeting the TSLP pathway, could expand the reach of our current respiratory biologics portfolio, including to the 40% of severe asthma patients with low T2 inflammation where treatment options are still needed.”1

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KeifeRx Expands Exclusive Licensing Agreement with Georgetown University to Include Multiple Disease Indications for Portfolio of Novel Tyrosine Kinase Inhibitors

KeifeRx is currently advancing programs investigating KFRX03, KFRX04, KFXR05 and KFX06 in neurodegenerative, neuroinflammatory, and mast cell-associated diseases

WASHINGTON, Jan. 8, 2024 /PRNewswire/ — KeifeRx, an emerging clinical-stage biopharmaceutical company specializing in the discovery and development of new treatment options for neurodegenerative and immune diseases, announced today entry into an amended exclusive licensing agreement with Georgetown University to advance the development of novel tyrosine kinase inhibitor (TKI) chemical entities (NCE) for the treatment of multiple disease indications. The amendment provides an extension of the exclusively licensed rights to these four novel chemical entities for the treatment of new disease conditions including inflammatory, mast-cell associated diseases, and oncology, in addition to existing rights in neurodegenerative diseases. KeifeRx is currently conducting optimizing and IND-enabling studies involving four separate formulations of the TKI (renamed KFRX03, KFRX04, KFRX05, and KFRX06) with patent life through 2037.

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Bio.News: With the new COVID surge, are we really post-pandemic?

January 9, 2024 / By  – National wastewater viral activity levels for COVID-19 have been  very high since December. (It wasn’t your imagination that everyone seemed sick over the holidays.) Currently, wastewater data is the best way to track COVID infections as most people are testing at home and not reporting their status. And currently, wastewater levels indicate that about 2 million Americans are getting infected each day.

This means that we are now in the second-highest COVID surge, after Omicron. As we hover around the fourth year of living with COVID, it is clear COVID could be endemic. With surges such as we are seeing now, personal safety measures are still very much needed—including (and especially) staying up to date on COVID vaccines.

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ARPAH

590th Edition, January 10, 2024

By BHI Weekly News Archives

 

Research and development (R&D) that will contribute toward Advanced Research Projects Agency for Health (ARPA-H) mission needs and Small Business Innovation Research (SBIR) program objectives.

 

The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals from small business concerns that possess the research and development (R&D) expertise to conduct innovative research that will contribute toward ARPA-H mission needs and Small Business Innovation Research (SBIR) program objectives.

SOLICITATION 75N91024R00006 is anticipated to be made available on or about January 23, 2024 through SAM.gov.  This solicitation is anticipated to have a closing date of February 22, 2024 for receipt of proposals.

The purposes of the SBIR program are to: (a) stimulate technological innovation; (b) strengthen the role of small business in meeting Federal research/research & development (R/R&D) needs; (c) foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns; and (d) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth. 

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QIAGEN receives FDA clearance of NeuMoDx CT/NG Assay for use on both NeuMoDx 96 and 288 Molecular Systems
  • NeuMoDx CT/NG Assay designed to improve accessibility, affordability and timeliness in sexually transmitted infection (STI) testing in the U.S.
  • U.S. regulatory clearance of new assay for use on both NeuMoDx 96 and 288 versions of integrated PCR-based clinical molecular testing system
  • Global presence anchored by 16 EU-certified in-vitro diagnostics (CE-IVD) tests, positioning NeuMoDx as having one of the broadest test menus available to customers

Germantown, Maryland, and Venlo, the Netherlands, Jan. 08, 2024 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) clearance for the NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States.

This assay is designed for direct detection of asymptomatic and symptomatic bacterial infections involving Chlamydia trachomatis (CT) and / or Neisseria gonorrhoeae (NG) – the most common type of bacterial infection among sexually transmitted infections (STIs), according to the U.S. National Institutes of Health. The majority of these infections are asymptomatic and generally curable with existing single-dose regimens of antibiotics. However, the time it takes for results to be received is often long, impeding follow-up care.

 

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Maxim Biomedical, Inc. Secures $49.5 Million Manufacturing Award from U.S. HHS to Strengthen Pandemic Testing Efforts

ROCKVILLE, Md., Jan. 4, 2024 /PRNewswire/ — MaximBio, a leading Maryland-based manufacturer specializing in lateral flow and diagnostic devices, is announcing the receipt of a $49.5 million award from the U.S. Department of Health and Human Services (HHS) through the Administration for Strategic Preparedness and Response (ASPR). This funding is designated to fortify the domestic manufacturing capabilities for diagnostic tests and enhance preparedness for potential future pandemics. The award is part of a broader initiative awarding $600 million to 12 domestic COVID-19 test manufacturers.

 

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ATCC Announces New Award from BARDA to Provide Centralized Storage and Bioprocessing Services for Project NextGen

Project NextGen is a $5 billion initiative to develop next-generation medical countermeasures, including vaccines and therapeutics, to enhance preparedness for future COVID-19 strains and variants.

MANASSAS, Va.–()–ATCC, the world’s premier biological materials management and standards organization, today announced a five-year, $87 million award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to support the development of next-generation medical countermeasures (MCMs) to protect Americans from public health security threats such as coronaviruses.

Through Project NextGen, BARDA is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID), as well as the private sector, to enable decreased cost, accelerated production, increased efficacy and improved access, strengthen a diverse pipeline of next-generation, innovative vaccines through clinical trials, and support the development of next-generation therapeutics. ATCC will provide cold-chain and lifecycle management of biological specimens from Project NextGen clinical studies.

 

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MaxCyte and Lion TCR form Partnership to Support Global Expansion of Lion TCR’s TCR-T Cell Pipeline

Lion TCR to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to develop and scale TCR-T cell therapies for solid tumors and viral-related diseases.

ROCKVILLE, Md. and SINGAPORE, Jan. 03, 2024 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics and innovative bioprocessing applications, and Lion TCR, an Asia-based, clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-T cell therapies for solid tumors and life-threatening viral infections today announced the signing of a strategic platform license (SPL). This partnership will enhance MaxCyte’s presence in Asia, with anticipated expansion into the US and European markets.

 

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TEDCO Invests in PediaMetrix

Maryland biotechnology company promotes improved patient outcomes for infants with body deformities

COLUMBIA, Md. (January 3, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 investment from its Life Science Investment Fund (LSIF) into PediaMetrix, a biotechnology company working to detect body deformities in infants and improve patient outcomes. TEDCO’s LSIF lives under the Seed Funds umbrella and invests in companies that have a Federal Drug Administration (FDA) pathway. Participating in this round were also Blu Ventures, as well as a pediatrician.

 

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Rockville’s GlycoMimetics Announces Positive Initial Safety and Pharmacokinetic Results from Phase 1a Healthy Volunteer Study of GMI-1687

ROCKVILLE, Md.–()–GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today announced positive initial safety, tolerability, and pharmacokinetic results from a Phase 1a study of GMI-1687 in healthy volunteers.

“These positive results represent an important milestone in the development of GMI-1687 as a potential point-of-care treatment option intended to help people living with sickle cell disease when they need it most, at the onset of pain crises,” said Harout Semerjian, Chief Executive Officer of GlycoMimetics. “Our Phase 1a data confirm this highly potent, second-generation E-selectin antagonist has an excellent profile for further development, with no dose-limiting toxicities or safety signals observed along with linear pharmacokinetics. We look forward to completing analysis of the study and advancing partner and financing discussions that support further development of this potentially important new therapeutic option for SCD.”

 

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FIERCE Biotech: JPM24 opens with ADCs the hottest ticket in San Francisco

The overall deal flow in biopharma tapered off in 2023 but the big companies sure know what they want (what they really, really want), according to a new report from J.P. Morgan.

And that’s antibody-drug conjugates, which drove a fourth-quarter spike in licensing deal proceeds and provided a glimmer of hope to an industry battered by outside forces and grim financing prospects.

J.P. Morgan’s annual 2023 Biopharma Licensing and Venture Report arrived on the eve of the firm’s famous conference, which is set to welcome thousands of attendees in San Francisco today—East Coast weather permitting.

2023 was tough, but clinical biotechs still had a lot of opportunities to wheel and deal, according to J.P. Morgan. While licensing deals, venture investments, M&A and IPOs were down overall in the fourth quarter, deal values stayed fairly high thanks to a flurry of late-stage tie ups.

 

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Montgomery College Announces the Appointment of Thomas Luginbill to Serve as Executive Director of the Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC)

Thomas (Tommy) Luginbill has accepted the position of executive director of the Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC). PIC MC is part of Montgomery College’s efforts to grow a hub of education, business, and entrepreneurship, where industry partners co-locate and actively interact with faculty and students to achieve both educational and economic success. In this capacity, Luginbill will continue to advance the development of this innovative science and technology hub in collaboration with academic, corporate and government partners. 

“I am honored to follow in the footsteps of those who have paved the way before me at PIC MC. Their dedication and hard work have laid the foundation for our mission,” Luginbill said. “We are committed to building upon this legacy, creating a vibrant hub for education, business, and innovation that will continue to thrive and benefit the Montgomery County community. Together with our partners, we are ready to embrace this challenge and honor the past while shaping the future.”

 

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TEDCO Announces New Board Member for the Maryland Innovation Initiative

Board appointees represent expertise of Maryland’s academic research institutions

COLUMBIA, Md., Jan. 4, 2024 /PRNewswire/ — TEDCO, Maryland’s economic engine for technology companies, announced the recent appointment of Christina DeMur, director of technology development at Johns Hopkins Technology Ventures, to the Maryland Innovation Initiative Board of Directors.

The Maryland Innovation Initiative (MII) was created as a collaboration between the State of Maryland and five Maryland academic research institutions: Johns Hopkins University (JHU); Morgan State University (MSU); University of Maryland, College Park (UMCP); University of Maryland, Baltimore (UMB); University of Maryland, Baltimore County (UMBC).

Recently this collaboration has expanded to include two more comprehensive universities – Frostburg State University and Bowie State University. This expansion will allow MII to further its reach and help bring more innovative research to the market.

 

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NIH: Artificial Intelligence and Your Health – How Computers are Helping Medicine

There’s a lot of talk about artificial intelligence, or AI, these days. AI is everywhere—from virtual assistants to facial recognition software. The technology is even assisting doctors and scientists. So what exactly is AI? And how is it helping advance scientific research?

“AI is basically trying to teach computers to ‘think’ in the same way as the human brain,” says Dr. Despina Kontos, an AI researcher at Columbia University.

One approach to AI uses a process called machine learning. In machine learning, a computer model is built to predict what may happen in the real world. The model is taught to analyze and recognize patterns in a data set. This training enables the model to then make predictions about new data. Some AI programs can also teach themselves to ask new questions and make novel connections between pieces of information.

 

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Solaxa and Rich 250 x 500 px

589th Edition, January 3, 2024

By BHI Weekly News Archives

 

Advancing Hope: Solaxa’s Quest to Treat Cerebellar Ataxias on the BioTalk Podcast

 

In this episode of BioTalk with Rich Bendis, we’re joined by three guests from Solaxa: CEO & Founder Christian Walker, Chief Operating Officer Luis T. Gutierrez, Jr., and Chief Commercial Officer Jennifer Butler. Solaxa is a pioneering biotech company with a mission to revolutionize the treatment of cerebellar ataxias and acute nerve injuries caused by trauma and chemotherapy.

Discover the compelling story behind Solaxa’s choice to establish its roots in Montgomery County and how the BioHealth Capital Region has played a crucial role in its growth. Learn how Solaxa’s team was assembled, including the inspiring success stories of Luis and Jennifer, both part of the BioHealth Innovation and Montgomery County Maryland’s Executive in Residence program.

Listen now via your favorite podcast platforms:

Apple: https://apple.co/3S3mDVJ
Google: https://bit.ly/3RJFZ0n
Spotify: https://spoti.fi/3RY4rwt
Amazon Music: https://amzn.to/3NMllvM
TuneIn: https://bit.ly/3NOtq2W

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BHI/NIH EIR Anna Zornosa: “Was 2023 Actually a GOOD Year in Women’s Health?”
  • The year “gaslighting” of women with hard-to-diagnose maladies was finally given the kabosh?
  • The year we found the hormone causing acute morning sickness?
  • Impressive and large funding rounds despite a bleak funding environment?
  • “Birth control for men” makes it to the clinical trial stage?

By Anna Zornosa – In the shadow of one very bad, no-good horrible development setting women’s health back decades (the overturning of Roe V. Wade), I spent the year taking note of some amazing advances happening in the pursuit of health solutions for women. Curious if others were also seeing bright spots, I asked some of the smartest women I know if they’d also seen events signaling notable progress.

My timing was bad: with the holidays upon us I knew some could not answer. But to my delight I got observations Barbara Levy, MD, FACOG, FACS : from CEO/Founders Somer Baburek, MBA (Hera Biotech), Melody Roberts (Liv Labs), and Melissa Bowley (Flourish Care); from author Susan Salenger; medtech designer and diversity driver Nada (Osman) Hanafi ; investors Jessica Karr and Susan Solinsky; and Ayse McCracken, Founder of the Ignite Accelerator for women leading life science companies.

What did we miss? A lot, certainly. Please add your own “brightspots of note” to comments. This will create something we can all turn to if (when) bad developments happen in 2024.

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Sonavex Announces Successful Clinical Study of EchoMark & EchoSure and Initiation of the MAFASA Randomized Controlled Trial

FDA IDE approval of Sonavex’s randomized trial comes months after meeting the endpoint of its first clinical study

BALTIMORE, Jan. 2, 2024 /PRNewswire-PRWeb/ — Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced that it completed its initial clinical study evaluating the ability to use EchoMark & EchoSure to improve the assessment of arteriovenous (AV) fistula maturation for dialysis patients. Following the positive findings from this study, Sonavex was granted approval from the U.S. Food and Drug Administration under an Investigational Device Exemption (IDE) for its randomized controlled trial, MAFASA (Maturation of Arteriovenous Fistula with Automated Sonography Assessments).

 

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The Frederick News-Post: CarrTech seeks FDA approval for product to prevent glass contamination in medication

Sue Carr clearly remembers the moment that pushed her to become a full-time entrepreneur.

In 2018, Carr was working at a hospital in Montgomery County and responding to a critical situation in the emergency room. She had to administer life-saving medication that was packaged in a glass ampoule — a small glass vial with a bottle head — to a patient.

To open the ampoule, the bottle head must be broken off, which Carr said results in glass shards getting in medication.

 

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588th Edition, December 19, 2023

By BHI Weekly News Archives

 

 

Navigating the AI Wave: Dr. Juergen Klenk Explores AI’s Reality in the BioHealth Industry on BioTalk

Have you ever wondered about the true impact of Artificial Intelligence (AI) in the BioHealth industry? In this episode of BioTalk with Rich Bendis, we have the privilege of hosting Dr. Juergen Klenk, a Principal at Deloitte and a Board Member at BioHealth Innovation. Dr. Klenk brings a wealth of expertise and experience with a unique background combining formal scientific training and entrepreneurial ventures.

Join us as we embark on an insightful discussion about the current state of AI in the BioHealth industry, diving deep into the realities and challenges of this cutting-edge technology. Dr. Klenk shares his interest in AI and the reasons behind its increasing prominence in the field. We explore the historical origins of the AI hype cycle and how we’ve reached the stage we’re in today.

Listen now via your favorite podcast platform:

 

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WBJ: United Therapeutics eyes big organ production facility in Silver Spring

By Dan Brendel – Staff Reporter, Washington Business Journal 

United Therapeutics Corp. is teeing up major organ production facility at its Silver Spring biotech campus through a proposed land swap with Montgomery County.

The company (NASDAQ: UTHR), a longtime drugmaker of pulmonary hypertension therapies that in recent years has expanded into bioengineered organs, has agreed to trade several parcels it owns for a county-owned site on 3.8 acres adjacent to its headquarters at 1000 Spring St.

The site, now home to a parking garage and other county operations, could yield up to 831,000 square feet under existing zoning.

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How Polaris Genomics, a JLABS @ Washington, DC resident, is leveraging the Health Equity Assessment Tool to enable a more equitable innovation process

December 11, 2023 – What if there was a diagnostic test that could confirm or predict post-traumatic stress disorder? 

And what if people from diverse backgrounds participated in clinical trials for its development?  

That’s a goal of Polaris Genomics, a Black- and veteran-owned resident company at JLABS @ Washington, DC. Its mission is to develop objective, genomics-based molecular diagnostic tools to accurately identify mental health conditions beyond the symptoms-based classifications laid out in the DSM-5. 

Charles Cathlin, CEO of Polaris Genomics and US Air Force veteran, first crossed paths with Tshaka Cunningham, Ph.D., and Chief Science Officer at Polaris Genomics in Washington, DC. Cathlin was Chief of Staff at the Defense and Veterans Brain Injury Center, while Cunningham worked as a Scientific Program Manager at the Veterans Affairs Medical Center. 

Cathlin observed the deteriorating mental health conditions of veterans and first responders during his time in the military and at Ground Zero following 9/11. Additionally, the historic mistrust of the healthcare system by Blacks has pushed them to conceive a way to also better support this historically marginalized patient demographic and to help prevent them from suffering in silence. 

 

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NeoImmuneTech and Imugene enter into strategic research collaboration to improve cancer treatments
  • The collaboration will evaluate the ability of NeoImmuneTech’s immune cell amplifier NT-I7 to increase the number of azer-cel allogeneic CAR T cells per batch during manufacturing.
  • The combination potential of azer-cel and NT-I7 to increase the number and cancer-fighting properties of the patients own T cells during their treatment with azer-cel, will be evaluated in preclinical work.

ROCKVILLE, Md., Dec. 11, 2023 /PRNewswire/ — Imugene Ltd (“Imugene”) (ASX: IMU), a clinical stage immuno-oncology company, and NeoImmuneTech, Inc. (“NIT”), (KOSDAQ: 950220) a clinical-stage T-cell-focused biopharmaceutical company, today announced a strategic collaboration to evaluate Imugene’s allogeneic CAR T, azer-cel, in combination with NIT’s proprietary immune T cell amplifier “Fc-fused recombinant human interleukin-7”, NT-I7, for the treatment of cancer.

Azer-cel is an allogeneic CD19 CAR T cell therapy program with extensive clinical data and a potentially fast-to-market development strategy. Azer-cel has demonstrated clinically meaningful activity with an acceptable safety profile in blood cancers such as lymphoma and leukemia.  

 

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citybiz: Irazu Oncology Secures $2.6M Debt to Advance UMB’s Vaccine Technology

Irazu Oncology, which is using a platform built by researchers at University of Maryland, Baltimore to develop cancer vaccines, has secured $2.6 million in debt from an undisclosed source, according to a recent listing on Crunchbase.

Founded by Marco A. Chacón, an industry veteran who founded and ran Paragon Bioservices for over two decades, Irazu Oncology is commercializing UMB’s novel immunotherapeutic vaccine technology. It operates out of the University of Maryland BioPark. The company is a winner of TEDCO’s Maryland Innovation Initiative Company Formation Awards.

Novel Approach

Irazu Oncology has a licensing deal with UMB to commercialize a membrane vesicle vaccine development platform built at the university by a research team led by James Galen, Ph. D. The platform uses the outer membrane of vesicles — a structure within or outside a cell — as cancer vaccines that can stimulate an immune response. Irazu Oncology’s proprietary, attenuated bacteria are engineered to produce OMVs bearing tumor antigens on their surface. These antigens are delivered to various sites in the body, stimulating a natural immune system that can destroy cancerous cells.

 

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Fierce Healthcare: Previous Crab Trap Winner Floreo nabs FDA breakthrough label for its VR software

By Anastassia Gliadkovskaya – Dec 11, 2023 4:00pm – 

Floreo, maker of virtual reality (VR) behavioral therapy content, has received the Food and Drug Administration’s breakthrough device designation. 

The company has also been accepted into the newer Total Product Life Cycle Advisory Program (TAP). While the breakthrough device designation helps streamline the process for medical device premarket approval, the TAP Program offers insights and resources to assist with the path to commercialization. 

“Floreo is seeking full market authorization and a label to further recognize its effectiveness in augmenting therapy and outcomes,” Vijay Ravindran, co-founder and CEO of Floreo, told Fierce Healthcare. The other goal with full market authorization is “opening up any and all reimbursement pathways so that Floreo can reach the million-plus families searching for better outcomes,” he added.

 

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University of Maryland, Baltimore Startup GlycoMantra Awarded $3.7 Million Small Business Innovation Research Phase II Grant

BALTIMORE, Maryland, December 11, 2023 – GlycoMantra, a University of Maryland, Baltimore (UMB) startup company developing therapeutics for unmet medical needs in metastatic castration-resistant prostate cancer (mCRPC), MASH liver fibrosis, and type 2 diabetes (T2D), was recently awarded a two-year, $3.7 million Small Business Innovation Research (SBIR) Phase II grant from the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health, to advance their therapeutic pipeline.

Currently, there are no United States Food and Drug Administration-approved drugs for mCRPC patients who develop a resistance to second-line hormonal therapies, or for the treatment of liver fibrosis or lung fibrosis. GlycoMantra is working to develop a therapeutic that will halt or reverse these diseases. The Phase II SBIR award will support the Company’s development of mammalian cell lines, a master cell bank (MCB), and the cGLP manufacturing for this drug.

 

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Smart Incentives: Our top incentive trends

As Smart Incentives marks its 10th year, we have been revealing the top ten ways that incentives have changed since 2013. We are pleased to share the full list of incentive trends here in our last blog article of 2023. 

1. Big incentive deals are getting bigger. Top projects receive significantly higher offers than in the past. The most prominent incentive packages are for new electric vehicle and semiconductor facilities. However, looking past these high profile projects, the average incentive offer has been surprisingly stable over the past decade.

2. The rise of remote work. Remote and hybrid work continue to reshuffle our living and working patterns. Incentives to attract remote workers have become part of the landscape. Many traditional business incentive programs are adjusting how they count workers to account for remote or hybrid work.

3. Better project compliance and reporting. State and local governments have improved their ability to track incentivized projects, monitor performance, and share results with internal and external stakeholders. 

 

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