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
The FDA and the Federal Trade Commission (FTC) have launched a campaign against false or misleading information about biosimilars that “may constitute unfair or deceptive practices” leading to decreased confidence in biosimilars. Read More