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Eli Lilly’s antiamyloid antibody solanezumab struck out in a highly anticipated phase 3 preclinical treatment study, failing to alter disease progression in people who had amyloid brain plaques but normal cognition.
Covis Pharma is willing to withdraw from the market its premature birth drug Makena (hydroxyprogesterone caproate injection), the company wrote in a letter to the FDA that requests the agency allow it an “orderly wind-down” period rather than an abrupt end to the drug’s availability.
Responding to FDA Commissioner Robert Califf’s recent remarks regarding the value of advisory committee (AdComm) votes, two major industry advocates offered slightly different takes on the question.
A federal appeals court has ruled in favor of Gilead Sciences, rejecting the Regents of the University of Minnesota’s claim the drugmaker violated the university’s patent protections for sofosbuvir, a Hepatitis C antiviral branded as Sovaldi, among others.
The FDA rapped German pharmaceutical company B. Braun Medical for failing to thoroughly review unexplained batch discrepancies, a quality control unit that lacks the authority over drug products, failure to follow production and process control procedures, and other lapses observed during an inspection of the company’s Daytona, Fla., plant. Read More