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The FDA’s proposal to give generic manufacturers the same labelling authority as brand manufacturers is nothing short of “illegal,” argue two prominent FDA observers. Read More
Teva’s zero-hour attempt to prevent generic competition to its blockbuster multiple sclerosis drug Copaxone was halted May 14 when a federal judge threw out its lawsuit calling for ANDA applicants to meet additional requirements. Read More
GlaxoSmithKline’s efforts to expand the indication for its cancer drug Arzerra were dashed when the drug failed to meet its primary endpoint in a Phase III trial. Read More
Proposed copyright requirements in a recent draft of the European Medicines Agency’s clinical trial data transparency policy run counter to EMA’s moves toward greater openness, researchers argue. Read More
The AstraZeneca board of directors on Monday rejected a sweetened, final merger offer from U.S. rival Pfizer, but at least one industry analyst expects wrangling will continue, especially if AZ shareholders step up and demand that the board returns to the negotiating table. Read More
House lawmakers want to give the FDA a $23 million increase in discretionary funds next fiscal year, but would restrict access to certain funds in a bid to prod the agency to finalize guidance on abuse-deterrent properties for opioids. Read More
Beleaguered Indian generics maker Wockhardt is recalling 109,744 bottles of the hypertension drug metoprolol due to problems with how the product dissolves in the body. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
Canadian drug regulators have temporarily banned Biolyse Pharma from making and selling its cancer-fighting agent paclitaxel after a series of inspections at the firm’s St. Catharines, Ontario, facility uncovered serious manufacturing problems. Read More
The FDA slapped Blue Ridge Pharmacy and Compounding Center with a warning letter for compounding products without a prescription and poor conditions for aseptic processing, another sign that the agency doesn’t plan to let up on large compounders. Read More