Aug. 28 P&P Quick Takes: Liver failure warning for HCV drugs; plus FDA guidances and more

Liver failure linked to HCV drugs
FDA said it has identified 63 incidences of worsening liver function, including cases of liver failure and death, in patients with liver impairment taking HCV drugs Mavyret glecaprevir/pibrentasvir from AbbVie Inc. (NYSE:ABBV), Zepatier grazoprevir/elbasvir from Merck & Co. Inc. (NYSE:MRK) and Vosevi sofosbuvir/velpatasvir/voxilaprevir from Gilead Sciences Inc. (NASDAQ:GILD). The agency said that the drugs are not indicated for patients with moderate to severe liver impairment, and advised physicians to assess the severity of a patient's liver disease and monitor for signs of worsening. The cases were reported to the FDA Adverse Event Reporting system (FAERS).

Breast cancer trials should not bar men
Sponsors should allow for the inclusion of men in clinical trials for breast cancer therapies, according to draft guidance released by FDA. When men have not been included, the agency recommends generating additional data using small-single arm trials or real-world data to support the efficacy and safety of a breast cancer candidate for use in men...