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.

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.

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.”

WILMINGTON, Del., September 20, 2024 – FLUMIST® has been approved in the US as the only self-administered influenza vaccine. FLUMIST, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age.1

The approval by the US Food and Drug Administration (FDA) was based on a comprehensive submission, which included results from a usability study demonstrating that individuals over 18 years of age could self-administer or administer FLUMIST to eligible individuals 2-49 years of age.1

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.

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.

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.