The Food and Drug Administration’s neuroscience chief Billy Dunn, who led the approval of Aduhelm, will leave the agency. “Billy has decided to retire from the FDA and explore other opportunities while continuing his focus on improving the lives of patients with neurological diseases,” Peter Stein, head of the Office of New Drugs, said in an email. (Endpoints News)
Irenic Capital urged Theravance to conduct a review and add a shareholder to its board of directors. Irenic owns a 4.2% stake in the biotechnology company and has criticized its lagging valuation and stock-based compensation to its chief executive and board chair, Rick Winningham. (Reuters)
SpringWorks Therapeutics’ New Drug Application for Nirogacestat was accepted by the FDA for desmoid tumors in adults. The clinical-stage biopharmaceutical company focused on severe rare diseases and cancer noted that the NDA was granted Priority Review and has been given a Prescription Drug User Fee Act action date of August 27. (MarketWatch)
The death of an 11-year-old Cambodian girl due to the H5N1 influenza virus prompted concern about how a human bird flu pandemic could unfold. In the 26 years since the H5N1 flu virus first emerged, there have only been 868 cases of human infection. However, the concerning part is that of these 868 cases, 457 have died, giving an estimated case fatality rate of 53 per cent, which makes the H5N1 virus one of the most lethal that we know. (BBC)
The Centers for Disease Control and Prevention issued a warning about the rise in highly drug-resistant stomach bugs. Shigella infections, known as shigellosis, usually cause diarrhea that can be prolonged and bloody, as well as fever and abdominal cramps. (The Washington Post)
