GERMANTOWN, Md., October 15, 2024 (Newswire.com) - Seraxis Inc., a clinical-stage regenerative medicine company, has received the FDA’s allowance of an Investigational New Drug (IND) application for a Phase I/II clinical study of its novel islet replacement therapy SR-02. SR-02 is the first reprogrammed stem cell-derived pancreatic product candidate allowed by the FDA for testing in humans as a potential functional cure for insulin-requiring diabetes.

ROCKVILLE, Md., Oct. 21, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced positive data from the Phase II fellow eye sub-study evaluating the subretinal delivery of ABBV-RGX-314 in patients with bilateral wet age-related macular degeneration (wet AMD). The new data were presented at the American Academy of Ophthalmology (AAO) meeting by Arshad Khanani, M.D., M.A., FASRS, Director of Clinical Research at Sierra Eye Associates, Reno, NV.

ROCKVILLE, Md., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced data from its exploratory open-label Phase 2a clinical study of SPN-820 in adults with major depressive disorder. The study examined the safety and tolerability of SPN-820 2400 mg given once every 3 days as an adjunctive treatment to the current baseline antidepressant therapy, as well as assessed the rapid onset of improvement in depressive symptoms. The analysis is based on 40 enrolled subjects, of which 38 completed the 10-day treatment period.

WASHINGTON, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Six medical technology innovators focused on pediatric cardiology were selected to receive grants of $50,000 each in the “Make Your Medical Device Pitch for Kids!TM” competition in Toronto. The funds will help awardees bring their devices to the market and improve care for children with heart conditions.  

WASHINGTON, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Six medical technology innovators focused on pediatric cardiology were selected to receive grants of $50,000 each in the “Make Your Medical Device Pitch for Kids!TM” competition in Toronto. The funds will help awardees bring their devices to the market and improve care for children with heart conditions.  

By Rebecca Barnabi: Published date:October 14, 2024 -  Thought leaders from academia and medical practice explored how artificial intelligence can advance children’s health care at the second annual Children’s National Hospital-Virginia Tech Symposium on AI for Pediatric Health at the Children’s National Research & Innovation Campus in Washington, D.C.

Rowland Illing, chief medical officer and director of international public sector health at Amazon Web Services (AWS), discussed the transformative impact of AI, machine learning and cloud technology.

This article originally appeared in the Association for the Advancement of Medical Instrumentation’s (AAMI) new Insights into Innovation series is authored by Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National and principal investigator of SPARK Innovations in Pediatrics, the BARDA Accelerator Network Hub for Special Populations.

October 21, 2024- In the realm of public health and emergency preparedness, one of the most pressing challenges is ensuring that children and special populations are adequately protected. The ongoing global threats—whether pandemics, natural disasters, or acts of terrorism—have highlighted the vulnerability of these groups. Children in particular face unique physiological and developmental risks that necessitate specialized medical countermeasures (MCMs). Yet, the development of pediatric-specific MCMs has long been hindered by significant regulatory, ethical, and financial challenges.

Addressing these concerns, the SPARK Accelerator, led by Children’s National Hospital in partnership with the Biomedical Advanced Research and Development Authority (BARDA), is poised to accelerate the development of medical countermeasures tailored to the pediatric population. With a consortium of partners, including BioHealth Innovation (BHI), CIMIT, University Hospitals Rainbow Babies and Children’s Hospital, and strategic industry players such as Johnson & Johnson Innovation JLABS, SPARK is creating a global hub that primarily focuses on innovations for children.

The tide has been rising in biotech investment in 2024—though it has not lifted all boats equally.

While the volume of investment improved in the first half of 2024, much of it went to a few “mega deals,” leaving many promising small biotechs still seeking funding, according to data presented during the Oct. 15 opening panel of the 2024 BIO Investor Forum in San Francisco, hosted by the Biotechnology Innovation Organization (BIO).

Still, the situation is improving, according to panelists in the session, “Understanding the Fundraising Environment for Biotech Companies,” which was moderated by Jesse Essaff, Director, Life Science & Healthcare, Commercial Banking – HSBC Bank USA.