BETHESDA, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, announces the initiation of the Multiple Ascending Dose (MAD) part of the Phase 1 clinical trial of GT-02287, Gain’s lead drug candidate for the treatment of GBA1 Parkinson’s disease.

Based on the safety and tolerability profile observed in the Single Ascending Dose (SAD) cohorts of the study, the Bellberry Human Research Ethics Committee (HREC) in Australia approved the start of the MAD part of the study in parallel with the completion of the last SAD cohorts. Following the HREC approval, administration of GT-02287 in the MAD part of the study has been initiated.

MANASSAS, Va. & TEL AVIV, Israel--(BUSINESS WIRE)--ATCC, the world’s premier biological materials management and standards organization, and Tissue Dynamics, a disruptive pharma-tech company integrating advanced artificial intelligence tools with bionic human organoids, today announced a partnership to develop workflow friendly cardiac organoids-based kits for improved cardiac safety testing in drug development. The collaboration will be done under the Israel-U.S. Binational Industrial Research and Development Foundation (BIRD) framework, which awarded both companies a two-year grant. The BIRD Foundation, established in 1977, bolsters transformative partnerships that stimulate, promote, and support industrial research and development in a wide range of technology sectors.

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.

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:
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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.

Click here to read the transcript.

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.

Click here to learn more.

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.

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.

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.

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. 

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.”

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.

By Sara Gilgore – Staff Reporter, Washington Business Journal - Feb 15, 2024 - 

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.

GSK plc (LSE/NYSE: GSK) today announced that it has completed the acquisition of Aiolos Bio (Aiolos), a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with respiratory and inflammatory conditions.

As previously announced,1 the acquisition of Aiolos includes 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. AIO-001 could expand GSK’s respiratory biologics portfolio to potentially reach the 40% of severe asthma patients with low T2 inflammation (a type of overactive immune response associated with asthma).2 AIO-001 has the potential to be administered every six months due to its high potency and long half-life, which could redefine the standard-of-care.

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. 

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.

Through this collaboration, Waisman Biomanufacturing will incorporate RoosterBio's cutting-edge MSC and exosome bioprocessing products, manufacturing protocols, and analytical services into its portfolio of biologics manufacturing services, expanding Waisman Biomanufacturing's capabilities for the production of advanced therapies for clinical trials.

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.

Contention over the Bayh-Dole march-in rights provision is in the news again. The National Institute of Standards and Technology (NIST) proposes using the process as a “back door” for drug price controls. In comments on NIST’s Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, the Biotechnology Innovation Organization (BIO) states that the clause cannot be used for price controls.

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.

WASHINGTON – Today, the National Advisory Council on Innovation and Entrepreneurship (NACIE) released its “Competitiveness Through Entrepreneurship: A Strategy for U.S. Innovation” (PDF) report that includes 10 recommendations for how the U.S. Department of Commerce, the federal government, and the private sector can foster an entrepreneurship ecosystem that ensures the United States leads in critical technology innovation.

U.S. Secretary of Commerce Gina Raimondo charged NACIE – a 32-member council comprised of leading entrepreneurs, innovators, investors, academics, and economic development leaders – with developing the report and recommendations with the aim of ensuring America’s continued global leadership in developing, commercializing, and scaling advanced technologies.

“America is the most competitive it’s ever been because we are home to the greatest innovators. But to maintain that position of power in the world, we need to keep making smart investments that will keep us ahead of the curve. That’s why the Biden-Harris Administration is laser-focused on building, strengthening, and investing in American technological innovation at every level of the economy and in every community,” said U.S. Secretary of Commerce Gina Raimondo. “NACIE’s report and recommendations provide a roadmap to help ensure America remains a global leader by expanding research and development, increasing access to capital, and fueling inclusive business growth across the country.”

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.

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/

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.

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.

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.

GAITHERSBURG, Md., Feb. 06, 2024 (GLOBE NEWSWIRE) -- NexImmune, Inc. a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells in oncology, autoimmune and infectious diseases, today announced the closing of its previously announced registered direct offering of 304,731 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $12.05 per share (or per common stock equivalent in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company also issued unregistered warrants to purchase up to an aggregate of 304,731 shares of its common stock at an exercise price of $12.05 per share. The warrants are exercisable immediately and have a term of two years from the date of issuance.

Biosim AI, founded by a professor at the University of Maryland in College Park, has closed on $12.25 million in its bid to commercialize technology to “enable and accelerate drug discovery at quantum accuracy.” So far, the company has raised $13 million, with investors including Armenia’s SmartGate VC, according to Crunchbase.

Armenian-born Garegin Papoian, Monroe Martin Professor at UMD’s Chemistry & Biochemistry and Institute for Physical Science and Technology, founded Biosim AI in 2020, raising a small pre-seed investment from his home country firm, SmartGate VC.

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.

J.P. Morgan has released its 2024 Innovation Economy Outlook, offering valuable insights for those interested in the future of venture capital, investment trends, and the landscape of startup exits. This report provides an in-depth analysis of the venture fundraising environment and the challenges and opportunities that lie ahead.

The outlook delves into key areas such as the interplay between public markets and venture capital, the direction of venture capital flow, and how valuation trends are shaping the industry. It also addresses the challenges business leaders face in this evolving market and evaluates the state of the exit environment, posing the question of whether it will facilitate a rejuvenated venture capital cycle.

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.

GAITHERSBURG, Md., Feb. 05, 2024 (GLOBE NEWSWIRE) -- BullFrog AI Holdings, Inc. (NASDAQ:BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, announced today the closing of an underwritten public offering of an aggregate of 1,507,139 shares of common stock (or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof) and accompanying warrants to purchase 1,507,139 shares of common stock at a public offering price of $3.782 per share (inclusive of the Pre-Funded Warrant exercise price) for gross proceeds of approximately $5,700,000, prior to deducting underwriting discounts and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase an additional 226,071 shares of common stock (and/or Pre-Funded Warrants in lieu thereof) and/or warrants to purchase 226,071 shares of common stock to cover over-allotments at the public offering price, less the underwriting discount.

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.

Global study will assess the safety and efficacy of the company's lead spinal fusion product, OsteoAdapt SP

FREDERICK, Md., Feb. 1, 2024 /PRNewswire/ -- Theradaptive, the market leader in targeted regenerative therapeutics, has gained approval from the U.S. Food and Drug Administration (FDA) for their Investigational Device Exemption (IDE) submission to begin enrolling patients into OASIS, their global Phase I/II Feasibility study in spine fusion.

With an aging population, more people will suffer from debilitating spinal conditions. Around 40% of adults over the age of 40 and 80% of adults over the age of 80 have at least one degenerated vertebral disc. Currently, more than 1 in 6 Americans are over the age of 65 and this proportion is increasing. However, current spinal fusion treatments can leave patients with sub-optimal outcomes, and often suffering from excruciating pain.

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