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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.

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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.

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.

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.

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. 

Are you ready to dive into the world of groundbreaking biotechnology and the fight against chronic diseases? In this episode of BioTalk with Rich Bendis, we bring you an enlightening conversation with Dr. Nehal Mehta, Founder and CEO of Mobius Scientific, Inc. Dr. Mehta is not only a distinguished Professor of Medicine but also a visionary entrepreneur on a mission to revolutionize healthcare.

Join us as we explore the journey of Mobius Scientific, an early-stage biotechnology company with a transformative approach. Mobius is developing cutting-edge biologic therapies targeting the root cause of chronic diseases, starting with lipid accumulation. This innovative platform has the potential to change the lives of millions suffering from debilitating conditions.

ARPA-H made its final hub location decision, selecting the historic Bowen Building in downtown Washington, D.C. as the site for its Stakeholder & Operations hub.

Why is this important? The new space will allow federal staff and contractors to work in one location, enhancing staff’s ability to manage programs and coordinate with federal partners—such as Congress, Health and Human Services, Centers for Medicare and Medicaid Services, U.S. Food and Drug Administration, the National Institutes of Health, and the Administration. Since the agency was authorized in March 2022, much of ARPA-H’s D.C. staff has been working remotely or from temporary offices.

WASHINGTON, Dec. 7, 2023 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has acquired U.S. and Canadian rights to PONVORY^® (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company. PONVORY^® is approved by the U.S. Food and Drug Administration (FDA) and Health Canada to treat adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. PONVORY^® has a proven safety profile with over 10 years of data.

“The acquisition of Ponvory is a significant milestone for Vanda, as it expands our commercial portfolio and gives us access to a versatile immune response modifier that can potentially have broad application in treating a number of autoimmune-based disorders,” said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board.

ROCKVILLE, M.D. and SUZHOU, China, Dec. 6, 2023 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, today announces the licensing deal expansion with Synaffix B.V., a Lonza company (SIX:LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index.

The expanded deal builds on a previous agreement signed in June 2021, under which Innovent is granted to deploy Synaffix’s ADC technologies on a target-specific, non-exclusive basis, including GlycoConnect®, HydraSpace® and one of its toxSYN® linker-payloads, for a therapeutic molecule (Innovent R&D code: IBI343, a CLDN18.2 ADC) which has advanced to Phase 1 clinical development.

WASHINGTON, Dec. 6, 2023 /PRNewswire/ — Danaher Corporation (NYSE:DHR) (“Danaher”) announced today it has completed its acquisition of Abcam plc (NASDAQ:ABCM) (“Abcam”).

The acquisition of Abcam for $24.00 per share in cash was implemented by way of a Court-sanctioned scheme of arrangement under the UK Companies Act 2006 (the “Scheme”) and the Scheme became effective in accordance with its terms on December 6, 2023. As a result, Abcam has become an indirect wholly owned subsidiary of Danaher. Trading of Abcam ADSs on Nasdaq has been suspended.

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–United Therapeutics (Nasdaq: UTHR), a public benefit corporation, today announced that the company has been named on Newsweek’s list of America’s Most Responsible Companies 2024. This award is presented by Newsweek and Statista Inc., the world-leading statistics portal and industry ranking provider. The list of awards was announced on December 6, 2023, is available on Newsweek’s website, and recognizes the top 600 most responsible companies in the United States, spanning 14 industries.

America’s Most Responsible Companies were selected based on publicly available key performance indicators derived from Corporate Social Responsibility Reports and Sustainability Reports, as well as an independent survey asking U.S. residents about their perception of company activities related to corporate social responsibility. The key performance indicators focused on company performance in the environmental, social, and corporate governance areas, while the independent survey asked U.S. citizens about their perception of company activities related to corporate social responsibility.

By Pratik Jain and Khushi Mandowara – Dec 5 (Reuters) – Weight-loss drug developer Altimmune (ALT.O) is open to deals and collaborations with large drugmakers as it actively looks for partners to launch and develop its experimental obesity drug, CEO Vipin Garg told Reuters on Tuesday.

Upbeat mid-stage trial data for its obesity drug and recent multi-billion dollar deals by companies such as Roche (ROG.S) and AstraZeneca (AZN.L) to grab a slice of the fast-growing market have fueled hopes of Big Pharma scooping up the company.

Gaithersburg, Maryland-based Altimmune last week reported mid-stage trial data for pemvidutide that showed the drug helped reduce weight by 15.6% on average and continued weight loss at the end of treatment.

For Immediate Release: December 08, 2023

Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy. 

Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S. It is most common in African Americans and, while less prevalent, also affects Hispanic Americans. The primary problem in sickle cell disease is a mutation in hemoglobin, a protein found in red blood cells that delivers oxygen to the body’s tissues. This mutation causes red blood cells to develop a crescent or “sickle” shape. These sickled red blood cells restrict the flow in blood vessels and limit oxygen delivery to the body’s tissues, leading to severe pain and organ damage called vaso-occlusive events (VOEs) or vaso-occlusive crises (VOCs). The recurrence of these events or crises can lead to life-threatening disabilities and/or early death. 

ALBEMARLE COUNTY, Va. (CBS19 NEWS) — State and local officials will be on hand for a groundbreaking ceremony at the University of Virginia on Friday.

UVA will be breaking ground on the Paul and Diane Manning Institute of Biotechnology.

According to a release, this institute will propel UVA to the forefront of cutting-edge medical research, fast-track the development of new treatments and cures, and transform the delivery of health care.

Biotech entrepreneur, company founder, tireless patient advocate, and U.S. Navy combat veteran will guide the life science industry in its mission to feed, fuel and heal the world

December 5, 2023

The Biotechnology Innovation Organization (BIO) is proud to announce that industry leader and military veteran John F. Crowley will be its new President and CEO, effective March 4. He will replace Rachel King, a longtime BIO board member and industry trailblazer who has served as BIO’s CEO on an interim basis for the past year.

Crowley is best known for his role as an entrepreneur in the biotechnology industry following the 1998 diagnosis of his two youngest children with Pompe disease, a rare and often fatal neuromuscular disorder. His children’s diagnosis inspired him to co-found a biotech company to develop a treatment that he credits with ultimately saving his children’s lives. The Crowley family journey was depicted in the major motion picture “Extraordinary Measures” starring Harrison Ford, Brendan Fraser, and Keri Russell. In 2005, Crowley went on to help found Amicus Therapeutics, a now 500+ person global biotechnology company, where he served as Chairman and CEO from 2005-2022 and is presently the company’s Executive Chairman. He will remain in that role until he transitions to BIO.

GAITHERSBURG, Md., Nov. 28, 2023 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced that the Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response at the United States Department of Health and Human Services has awarded a $75 million option to Emergent’s existing contract (HHSO100201600030C) for the acquisition of newly licensed anthrax vaccine CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted). Deliveries are expected to begin this calendar year and be complete by the end of the first quarter of 2024.

Previously known as AV7909, CYFENDUS™ vaccine was approved by the U.S. Food & Drug Administration (FDA) in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 years of age and older. Anthrax is considered a high-priority national security threat and has the potential for major public health impact.

WAKEFIELD, Mass., Nov. 29, 2023 /PRNewswire/ — 424 Capital announced today that it has completed a significant investment in VaLogic, a leading provider of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance software and services based in Frederick, MD. This strategic move by 424 Capital aims to expedite positive clinical outcomes by enabling pharmaceutical and biotechnology organizations to focus on the research, development, and production of cutting-edge therapeutics in a compliant and effective manner.

Founded in 2001 by CEO Bill Robertson, VaLogic provides a comprehensive range of software and compliance services to the life science and biotechnology market. These services help organizations and facilities maintain GMP compliance and enact high standards while focusing on advancing life-saving therapeutics.

VaLogic offers advisory and facility design, full commissioning and qualification, cleanroom environmental monitoring, HEPA/cleanroom certifications, calibration, preventative maintenance, and a proprietary SaaS software called LogiPoint™ for continuous monitoring of critical facilities and equipment.

The Biological and Emerging Infections Research Resources Program (BEI-RRP) contract, which merges the two programs, represents the fourth recompete award with NIAID since 2003.

MANASSAS, Va.–(BUSINESS WIRE)–ATCC, the world’s premier biological materials management and standards organization, today announced a seven-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to continue the management of the BEI Resources Program. NIAID has made an initial award of over $21.5 million, with further funding expected if all project milestones are met. This contract will merge the NIH HIV Reagent Program with the BEI Resources Program under the Biological and Emerging Infections Research Resources Program (BEI-RRP) umbrella. ATCC has managed the BEI Resources Program since 2003 and the NIH HIV Reagent Program since 2020. This important merger will allow researchers to have streamlined access to all priority pathogens for human health under one program.

“Through our successful collaboration with NIAID, we have helped consolidate ten other repositories that provide critical materials to the infectious disease research community,” said ATCC chairman and CEO Raymond H. Cypess, DVM, Ph.D. “At ATCC, we understand why curated, high-quality biomaterials, reagents, and products are critical to achieving credible research results. We also recognize why streamlining access to these items is essential so researchers can develop the diagnostic tests, vaccines, and therapies needed to improve human health.”

AI Simulation on MIRA1a Showcases Significant Potential Advantages Over Plant-Based Medical Marijuana Related to Anxiety, Appetite and Cognition

BALTIMORE, Dec. 4, 2023 /PRNewswire/ — MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”), an innovative pre-clinical-stage pharmaceutical company focused on neurologic and neuropsychiatric disorders, has released new data from artificial intelligence (AI) simulations that show that, compared to plant-based medical marijuana, there may be significant potential advantages to the therapeutic potential of MIRA1a, such as its potential to offer a superior anti-anxiety treatment, increased cognition and without the increased appetite associated with THC.

The simulations on MIRA1a were conducted in conjunction with the Company’s strategic collaboration with InSilicoTrials, a company specializing in leveraging AI and simulations to enhance drug and medical device development.

MENLO PARK, Calif., Dec. 4, 2023 /PRNewswire/ — Enavate Sciences, a portfolio company of Patient Square Capital, is pleased to announce that Sara M. Nayeem, M.D. has joined the firm as Executive Vice President, Investments. Dr. Nayeem reports to James Boylan, Chief Executive Officer of Enavate Sciences, and will serve an integral role in the origination, evaluation, and selection of Enavate investments, as well as support Enavate partner companies on governance, partnerships, fundraising, and other strategic initiatives.

Dr. Nayeem has 20 years of banking and institutional investing experience. She most recently served as Partner at Avoro Ventures, a biopharma venture fund she helped launch in 2021. Previously she was a Partner at New Enterprise Associates, Inc. (NEA), where she spent 12 years as part of the biopharma investing group. Prior to joining NEA, Dr. Nayeem was an Associate with Merrill Lynch’s Global Healthcare Group, where she advised biotechnology and medical device companies. She began her career as an Investment Banking Analyst at Morgan Stanley.

The National Heart Lung and Blood Institute (NHLBI) in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) will be providing training and resources for a new Innovator to Entrepreneur Program (ITEP). ITEP is designed to assist aspiring entrepreneurs by providing them with cohort-based training covering key elements of company launch, business strategy development, IP protection, market research, customer discovery, startup financing and SBIR/STTR grantsmanship.   

This new program encourages participation in the SBIR/STTR program by underrepresented groups, Women-Owned Small Businesses, socially/economically disadvantaged small businesses, and small businesses located in HUBZones programs.  

Attend the Informational Webinar on December 6th at 2PM ET to learn more about the new ITEP program. Information about ITEP is available on the ITEP website.  ITEP will begin accepting applications of interest on December 8th.  

What is the dynamic synergy between pioneering science and transformative industry developments? Join us in this episode of BioTalk with Rich Bendis for a thought-provoking conversation about the work of Blackbird Laboratories. Our guest, Matt Tremblay, Ph.D., Chief Executive Officer of Blackbird Laboratories, sheds light on their role in fostering innovation within the vibrant BioHealth community of Baltimore and the wider BioHealth Capital Region.

Blackbird Laboratories recently launched with a significant $100 million founding grant from The Stephen and Renee Bisciotti Foundation. This significant investment aims to bridge the gap between academic research and industry innovation, catalyzing the development of innovative companies, groundbreaking technologies, and a thriving entrepreneurial ecosystem in Baltimore, Maryland. They provide crucial support, including capital, program management, and strategic scientific and business insights, to drive the growth of the BioHealth industry. Their team of seasoned life sciences professionals operates on a value-driven model, committed to reducing the risk of groundbreaking technology for commercialization, attracting crucial investments, nurturing start-ups, and cultivating meaningful public-private partnerships. Their vision is grounded in promoting a thriving ecosystem in Baltimore that will contribute significantly to the growth of the BioHealth sector in the region.

Are you navigating the complex terrain of healthcare innovation? The National Institutes of Health (NIH) offers a powerful tool to guide your journey: the TABA Needs Assessment Report. This complimentary, unbiased report is a game-changer for companies in the critical Phase I of their projects.

What Does the Report Offer?

The TABA Needs Assessment Report is a comprehensive evaluation tool that scrutinizes four pivotal areas:

1. Intellectual Property and Market Entry: It assesses your project’s intellectual property and potential barriers to entering the market.
2. Market Positioning: The report evaluates your project’s standing in the competitive healthcare landscape.
3. Regulatory and Clinical Strategies: It reviews your plans in regulatory compliance, manufacturing, and clinical trials.
4. Business Model Analysis: The report delves into the profitability and sustainability of your business model.

As the year 2023 comes to a close, CarrTech Corp has demonstrated remarkable progress and innovation in the biotechnology and medical device sectors. The company has achieved several milestones, engaged in significant collaborations, and is poised for further advancements in the coming year. Here are some of the key highlights from CarrTech Corp’s journey over the past year:

COLUMBIA, Md. (November 27, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 Social Impact Funds investment into NasaClip.

“Nosebleeds are common, and often don’t require medical intervention. In fact, with emergency treatment many patients end up walking out of the hospital later than anticipated and in more pain than when they entered,” said Dr. Elizabeth Clayborne, CEO and founder of NasaClip. “Thanks to TEDCO’s investment we can continue our efforts to provide a more timely, efficient and cost-effective solution for patients, allowing them to get treated from the comfort of their own homes.”

BioHealth Innovation is thrilled to announce that our esteemed Entrepreneur-in-Residence, Kwame Ulmer, has been recognized by Quroba for his outstanding contributions to the MedTech industry. This recognition is a testament to Kwame’s exceptional journey and his relentless pursuit of innovation in healthcare technology.

From Quroba’s Post:

“This month, we’re honored to shine the spotlight on a true industry luminary, our very own Kwame Ulmer.

With two decades of experience in evaluating medical technologies across both government and private sectors, Kwame’s expertise is nothing short of exceptional.

Are you ready to explore the transformative world of MedTech and its profound impact on healthcare? Join us in this episode of BioTalk with Rich Bendis as we dive deep into medical technology with an exceptional guest, Neal Piper, Founder & CEO of Luminoah, winner of the 8th Annual BioHealth Capital Region Crab Trap. Neal Piper is the visionary behind Luminoah, a cutting-edge MedTech company dedicated to enhancing the lives of enteral nutrition patients through innovative hardware and software systems. With a background steeped in healthcare, Neal’s journey from Pfizer’s Neuroscience Division to his role as President of the Global Health Fellows Alumni Business Network has uniquely positioned him to drive change in the industry. But what inspired Neal to create Luminoah? In 2019, his family received a cancer diagnosis for their 3-year-old son, leading to a new reality and a pressing need for a better nutritional feeding program. Neal recognized the challenges faced by patients and caregivers, from bulky equipment to limited data sharing with physicians. That’s when Luminoah was born.

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WATERTOWN, Mass. and GAITHERSBURG, Md., Nov. 13, 2023 (GLOBE NEWSWIRE) — Selecta Biosciences, Inc. (NASDAQ: SELB) (the Company) today announced that it has merged with Cartesian Therapeutics, Inc., a clinical-stage biotechnology company pioneering RNA cell therapies for autoimmune diseases. In connection with the merger, Selecta announced a $60.25 million private financing led by Timothy A. Springer, Ph.D., member of the Selecta Board of Directors.

With the cash from both companies at closing and the proceeds of the concurrent private financing, the combined company is expected to have over $110 million on hand to support the development of the Cartesian pipeline through the Phase 3 study of lead product candidate, Descartes-08, a potential first-in-class RNA-engineered chimeric antigen receptor T-cell therapy (rCAR-T) for the treatment of MG, as well as the advancement of additional RNA cell therapy programs.

Concurrent with the merger, the combined company has been renamed Cartesian Therapeutics, Inc. The Company’s Nasdaq ticker symbol will change to “RNAC” effective prior to the opening of trading tomorrow, November 14, 2023.

Today, President Joe Biden announced his intent to appoint Dr. W. Kimryn Rathmell as the 17^th Director of the National Cancer Institute (NCI), the federal government’s principal agency for cancer research and training and the largest funder of cancer research in the world. Dr. W. Kimryn Rathmell is an accomplished physician-scientist and internationally recognized cancer expert who is well suited to lead the NCI during this critical time to achieve the goals the President set for the Biden Cancer Moonshot as part of his Unity Agenda. 
 
Statement from President Biden: “Dr. Rathmell is the talented and visionary leader the National Cancer Institute needs to drive us toward ending cancer as we know it.  Throughout her career, she has been committed to advancing discovery through scientific research, maintaining a steadfast commitment to caring for her patients, and demonstrating leadership in preparing the next generation of researchers. She embodies the promise of the Biden Cancer Moonshot and has spent her career driving toward the goals Jill and I set for the initiative, to improve outcomes and boost support for those facing a cancer diagnosis. The National Cancer Institute is central to the success of the Cancer Moonshot and Dr. Rathmell will lead the agency towards new ways to prevent, detect, and treat cancer and to ensure we reach more Americans with the tools we have to save and extend lives.”

What are the latest advancements in cancer research and innovation? Join us in this episode of BioTalk with Rich Bendis as we explore the dynamic world of cancer research and technology development with our distinguished guest, Michael Weingarten, Director of the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI).

Mr. Weingarten plays a pivotal role in leading a team of Program Directors managing the NCI's SBIR & STTR Programs, overseeing a substantial portfolio of $182 million in grants and contracts annually. These programs are at the forefront of NCI's efforts to drive innovation, fostering the development and commercialization of groundbreaking technologies and products for cancer prevention, diagnosis, and treatment.

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Explore the intersection of the BioHealth Capital Region and the NCI, understanding how collaboration and partnerships are shaping the future of cancer research and innovation. Michael and Rich delve into the goals for the future, highlighting the NCI's vision and commitment to advancing cancer prevention, diagnosis, and treatment through technology and innovation.

GAITHERSBURG, Md., November 7, 2023 – Emergent (NYSE: EBS) has recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for the expansion of the indication for ACAM2000®, Smallpox (Vaccinia) Vaccine, Live to include immunization against mpox virus. The sBLA includes data from a well-controlled animal study in which ACAM2000® vaccine has been shown to be effective in protecting against mpox virus exposure.

“Community transmission of mpox continues to be a public health challenge in the U.S.,” said Paul Williams, SVP and Products Business Head, Emergent BioSolutions. “Our sBLA submission for ACAM2000® reflects Emergent’s commitment to expanding our product capabilities and continuously support the U.S. government as we address emerging infectious diseases and strengthen future preparedness.”

Mpox, formerly called monkeypox, is a rare disease caused by infection with the mpox virus. Mpox virus is part of the same family of viruses as variola virus, the virus that causes smallpox. Mpox symptoms are similar to smallpox symptoms, but milder, and mpox is rarely fatal.¹ Since the start of last year, there have been more than 31,000 mpox cases in the U.S. and 55 deaths, according to the CDC, with more than 91,000 cases and 166 confirmed deaths globally.

A life sciences accelerator called Blackbird Laboratories has $100 million to spend to turn Baltimore into a biotech hub.A life sciences accelerator called Blackbird Laboratories has $100 million to spend to turn Baltimore into a biotech hub.

Blackbird was founded at the start of this year with the backing of Baltimore Ravens owner Steve Bisciotti’s family foundation. So far, Blackbird has looked at about 80 to 100 proposals and funded five programs, Blackbird CEO Matt Tremblay told Endpoints News.

Baltimore has had a few notable biotech success stories, such as Thrive Earlier Detection (acquired by Exact Sciences in 2020) and Personal Genome Diagnostics (acquired by Labcrop in 20222), but Tremlay said he hopes to support a "Kendall Square-like phenomena." He's looking to back research ideas that ultimately become biotech startups based in Baltimore. 

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Are you curious about the world of transformative regenerative medicine and stem cell research? Are you eager to understand how Maryland champions researchers and companies in the field of stem cell and regenerative medicine? Do you want to learn more about the Maryland Stem Cell Research Fund (MSCRF)? Listen to the latest episode of BioTalk with Rich Bendis as he welcomes MSCRF Executive Director, Ruchika Nijhara, PhD.

In this enlightening episode, Dr. Nijhara, a forward-thinking leader driven by her passion for advancing scientific innovation, delves into the funding mechanisms that Maryland employs to support research and development at all stages and fosters collaboration and innovation.

October 30, 2023 06:00 AM Eastern Daylight Time – SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. & EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–United Therapeutics Corporation (Nasdaq: UTHR) and Miromatrix Medical Inc. (Nasdaq: MIRO) announced today a definitive agreement for United Therapeutics to acquire Miromatrix.

Miromatrix is a life sciences company focused on the development of bioengineered organs composed of human cells. United Therapeutics is a biotechnology company with six FDA-approved therapies to address rare, life-threatening conditions, and a pipeline that includes four ongoing registration-phase studies. The acquisition of Miromatrix will expand United Therapeutics’ existing complementary platform of organ manufacturing programs, which include ex-vivo lung perfusion, xenotransplantation, 3-D bioprinting, and regenerative medicine approaches with the objective of creating an unlimited supply of tolerable, transplantable organs.

Six new products that can be used to detect residual host cell genomic DNA (gDNA)

MANASSAS, Va. and ROCKVILLE, Md., Oct. 30, 2023 /PRNewswire/ — Today, ATCC and U.S. Pharmacopeia (USP), two premier materials management and standards organizations, announced the launch of their first set of joint products to advance the quality control and reduce the risk in the manufacturing of biological therapies and vaccines. This initial set of six products consists of highly characterized and pure genomic DNA (gDNA) from cell lines used in bioproduction that can be used to measure residual host cell DNA in various biotherapeutic products, as required by regulatory authorities. The presence of gDNA is a predominant concern in the development of biological therapies as it can pose a safety risk if it is not removed from the product.

“Developing cutting-edge medicines in the biologics space requires trusted reference materials and standards to ensure quality, consistency and safety,” said Amanda Cowley, General Counsel and SVP Legal, Strategy and People of USP. “With increased demands around the globe for new biological medicines on accelerated timelines, it’s essential that there are products and solutions that can be used to address and advance quality assessment and bring confidence to the development process. By focusing on the detection of gDNA, this first set of ATCC and USP products is significant for the future of biological development as it addresses a common concern when it comes to quality and mitigating risk.”