There is no question someone is over-reacting to safety issues with Biogen Idec/Elan's Tysabri and Lilly/Amylin's Byetta. But is it FDA-or investors?
By Michael McCaughan
Since the dayBiogen Inc. and Elan Corp. PLC reintroduced the multiple sclerosis agent natalizumab (Tysabri) in 2006, the...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.
Clarity on payer responses to controversial vaccine recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices may be coming.
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
