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U.S. Pharmacopeia (USP) is currently seeking Expert Volunteers from diverse professional backgrounds to contribute to its vital mission of safeguarding the quality of medicines, dietary supplements, and food ingredients. For over 200 years, USP has maintained trust in healthcare products through rigorous standards, and now they are calling on scientists, healthcare professionals, regulatory experts, and academicians to join them for the 2025–2030 cycle.

Volunteering with USP offers a unique opportunity to work alongside global experts from academia, industry, and regulatory bodies to help review and revise USP standards. These standards are essential for public health, legally recognized in the U.S., and used in over 150 countries. Volunteers will lend their expertise to address emerging health concerns, build awareness, and reduce the risk of substandard healthcare products. As a part of an Expert Committee, you’ll help shape global healthcare and contribute to ensuring that consumers worldwide have access to safe and reliable products.

ROCKVILLE, Md. and SOUTH SAN FRANCISCO, Calif., Sept. 15, 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 Kamau Therapeutics, a clinical-stage stem cell therapy gene correction company, today announced they are entering into a strategic platform license (SPL) agreement.

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

RICHMOND, Va., Sept. 17, 2024 /PRNewswire/ — Activation Capital proudly announces the launch of Start-the-Journey, a new BioHealth Pre-Accelerator designed to equip early-stage biotech and life science entrepreneurs with the knowledge and tools to build successful startups. Powered by Fat Robin Consulting, this innovative program supports founders in the initial phases of their entrepreneurial journey, preparing them for more advanced initiatives like Activation Capital’s Frontier BioHealth, launched earlier this year to support scaling advanced-stage startups.

What’s happening? ARPA-H is launching the Emerging Health Innovators (EHI) Initiative to increase access to government research funding for early career researchers and community health innovators to address health care gaps in the U.S.

Why it matters? Early career researchers and community health innovators, including those from minority-serving institutions and community-based organizations, will now have more opportunities to pursue bold and technically risky R&D projects, but who have been unable to take these leaps using traditional funding opportunities.

TOKYO, September 18, 2024 — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that DIGITIVA™, a non-invasive digital health solution for heart failure management, has been listed with the U.S. Food and Drug Administration (FDA). DIGITIVA is classified as a Class I Software as a Medical Device (SaMD) and is exempt from 510(k) premarket submission*. DIGITIVA is the first digital health offering from Astellas in the U.S.

DIGITIVA is designed to place patients impacted by heart failure at the center of their care, allowing them to take a more active role in managing their health while working in partnership with their care team. DIGITIVA is comprised of three components: the CORE 500™ Digital Stethoscope developed by Eko Health Inc., a smartphone app designed for heart failure patients and built on the Welldoc, Inc. platform, bolstered by educational content from the American Heart Association, and a dedicated clinical review team. The DIGITIVA clinical review team triages patient data, including previously elusive biomarkers specific to heart failure, and notifies the patient’s treating physician when certain signals are present that may indicate the patient would benefit from intervention, with the goal of impacting clinical outcomes such as acute decompensation events and re-hospitalizations.

Clinicians caring for children are often left to rely on off-label devices and medications approved for adults, especially during national disasters and other emergencies. Children’s National Hospital is launching a new partnership with the federal Biomedical Advanced Research and Development Authority (BARDA) to develop much-needed solutions for this vulnerable population.

This new pediatric-focused hub will be known as the SPARK Hub—or the Hub for Special Populations Acceleration, Research and Knowledge for Innovations in Pediatrics. It will join a network of four existing BARDA hubs to develop various tools for national health emergencies, including infectious disease outbreaks or chemical, biological, radiological and nuclear attacks. The new opportunity for Children’s National positions the organization as a leader among those working to ensure clinicians and their patients have the resources they need in crises, approved for kids and ready for clinical use.

With COVID-19 still spreading and mpox emerging as a public health emergency of international concern, the National Institutes of Health (NIH) is upping preparations for future pandemics.

The Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness network (ReVAMPP) will research pathogens that currently lack effective treatments and vaccines, with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) committing up to $100 million per year to the effort so long as funds are available, the agency announced Sept. 13.

“In the wake of the COVID-19 pandemic and ongoing outbreaks of emerging infectious diseases, the need for robust pandemic preparedness is evident,” NIAID Director Jeanne M. Marrazzo, M.D., said in the release. “The ReVAMPP network will enable researchers to fill key knowledge gaps and identify strategies to develop safe and effective medical countermeasures for targeted virus families before the need becomes critical.”

WASHINGTON, DC (September 17, 2024) – Today, the Biotechnology Innovation Organization (BIO) awarded Virginia Governor Glenn Youngkin with its 2024 Governor of the Year Award. 

BIO’s annual award honors governors for their leadership and commitment to strengthening biotechnology in their state. For over a decade, the award has recognized governors from across the country and both sides of the aisle.

“Investing in biotechnology is investing in Virginia’s future,” said Governor Glenn Youngkin. “As the Commonwealth’s cutting-edge research triangle and network continues to expand, my administration is determined to remain at the forefront of fostering innovation. I am incredibly humbled to receive this award, and I look forward to further solidifying Virginia’s role as a leader in the life sciences industry.”

COLUMBIA, Md., Sept. 17, 2024 /PRNewswire/ — The Maryland Stem Cell Research Commission (MSCRC) announces the allocation of approximately $4.5 million in new grant awards to advance stem cell research and technology. These grants will drive innovative research with the potential to deliver life-saving treatments and transformative cures for patients with a variety of medical conditions.

This award has been awarded to 11 accomplished scientists from Maryland-based institutions and companies. The awardees include researchers from renowned academic institutions such as Johns Hopkins University and the University System of Maryland, as well as pioneering companies such as Therapative Inc. and Caleo Biotechnologies, Inc. Non-profit organizations, including Regenerative Orthopedics and Sports Medicine, LLC are also among the recipients. The grants will support critical research into treatments for brain diseases such as Alzheimer’s and dementia, blindness, autoimmune diseases, inflammatory bowel disease and orthopedic conditions, among others.

The much-anticipated BioHealth Capital Region Week is finally upon us, promising three days packed with keynotes, competitions, and invaluable networking opportunities. Here’s what attendees can look forward to each day:

Day 1 Highlights: The 10^th Annual BioHealth Capital Forum will open with two special guests—one in the morning and another in the afternoon—setting the tone for a day of high-level discussions and networking opportunities. Keynotes for the day include:

• AMGEN’s Entrance to the BioHealth Capital Region: Robert Stoffel, VP of Rare Disease, Complex Biologics, and Strategic Technology Alliances at Amgen, will discuss the company’s strategic initiatives and their impact on the region.
• State of the Bio Industry: John Crowley, President and CEO of BIO, will provide an insightful look into the current landscape and future directions of the Bio industry.

Day 2 Highlights: Day two features the highly competitive Crab Trap competition with finalists Cerillo, Immobazyme, Linshom Medical, Liquet, Optosurgical, and Plakous Therapeutics. These innovative companies will pitch their groundbreaking advances to a panel of esteemed judges.