Response rates of 30%-43% and a 7.6-month median duration of response were sufficiently clinically meaningful to allow FDA approval of Genentech’s basal cell carcinoma treatment on the basis of a non-randomized study.
FDA has been encouraging oncology drug sponsors to move away from pursuing initial approval based on single-arm studies, but in the case of Genentech Inc.’s Erivedge (vismodegib) the agency harbored little concern about approving the basal cell carcinoma drug on the basis of such a limited data package once it saw the pivotal trial results.
The adequacy of the clinical efficacy data – comprising a single-arm trial, a limited number of patients and a primary...
While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.
Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
