Northeastern University

FDA Approval of Humacyte's Artificial Blood Vessel Faces Petition for Revocation Amid Safety Concerns

2 months ago

• Northeastern University researchers have formally petitioned the FDA to revoke approval of Humacyte's artificial blood vessel Symvess, citing deficient clinical trial data and safety concerns. • The FDA approved Symvess in December despite internal objections from agency scientists, including a vascular surgeon who retired in protest, raising questions about regulatory oversight. • Clinical trial data showed concerning outcomes among 54 study participants, including four deaths and four amputations, while Humacyte reported an 84% success rate compared to the FDA's finding of 67%.

NIH Funding Cuts Under Trump Administration Threaten Early-Stage Biopharma Innovation

3 months ago

• The Trump administration has implemented a $4 billion reduction in NIH overhead funding, cutting indirect cost rates to 15% and disrupting grant review processes for biomedical research. • NIH SBIR and STTR grants for innovative drug development totaled $1.4 billion between 2020-2025, with over 80% supporting crucial preclinical and discovery stage research. • Recent policy changes, including funding freezes and increased scrutiny of grant applications, could significantly impact biotech startups and delay global drug development efforts.

Flashing Lights and Gamma Waves: A Novel Approach to Stalling Alzheimer's

8 months ago

• Researchers are exploring the use of flashing lights and rhythmic sounds to stimulate gamma waves in the brain, potentially combating Alzheimer's disease. • Early clinical trial data shows encouraging evidence of neuroprotection and cognitive benefits with 40-hertz sensory stimulation, without serious side effects. • A large, randomized trial involving over 600 participants is underway to further validate the efficacy of this unconventional therapy. • Concerns exist regarding unregulated 'wellness' devices that market similar technology, potentially outpacing scientific validation and harming consumers.

Loyal's Anti-Aging Drug for Senior Dogs Enters Clinical Trials, Aims to Extend Healthy Lifespan

a year ago

• Loyal's LOY-002, a novel anti-aging drug targeting metabolic health in senior dogs, has entered clinical trials, potentially extending their healthy lifespan. • The STAY study, involving over 1,000 dogs across 50+ vet clinics, will assess LOY-002's impact on lifespan and quality of life compared to a placebo over four years. • LOY-002 aims to delay the onset and reduce the impact of age-associated diseases by improving metabolic fitness in older dogs. • Loyal anticipates conditional FDA approval for LOY-002 by early 2025, with plans to launch LOY-001, a longevity drug for large breeds, in 2026.