The Food and Drug Administration’s outside experts voiced concerns about an experimental gene therapy for Duchenne muscular dystrophy from Sarepta Therapeutics. The stakes for this all-day meeting were high and deliberations were contentious. (STAT News)
U.S. lawmakers will ask regulators to investigate whether the make-up of a panel overseeing animal testing at Elon Musk’s brain-chip startup Neuralink contributed to botched and rushed experiments. Representatives Earl Francis Blumenauer and Adam Schiff, both Democrats, have signed a draft letter to the U.S. Department of Agriculture requesting a probe into how Neuralink oversaw its experiments. (Reuters)
The Department of Health and Human Services has plans to build out “Project NextGen,” an initiative similar to Operation Warp Speed that will seek to develop future COVID-19 vaccines. Of the $5 billion in funds, $4.7 billion will go towards BARDA and the other $300 million to the National Institute of Allergy and Infectious Diseases. (Axios)
The first epinephrine nasal spray cleared a key hurdle with the FDA, promising a needle-free alternative. The majority votes backing the spray for both adults and kids followed a daylong meeting of the agency’s Pulmonary-Allergy Drugs Advisory Committee. (CBS News)
Clearmind Medicine secured approval to launch a clinical trial for alcohol addiction treatment. The Israeli biotech discovers and develops novel psychedelic-derived therapeutics for major undertreated health problems. (Benzinga)
