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Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city, as well as other India manufacturers. Read More
The FDA was not happy that Elite Laboratories’ quality unit failed to validate and review various product batches before distribution, landing the generic drug maker a Form 483. Read More
The FDA is turning up the heat on drugmakers who don’t pay their generic drug user fees, warning its tenth manufacturer since the summer for delinquent fees. Read More
The FDA issued a warning letter to injectables giant Hospira after an investigation of its Victoria, Australia, plant uncovered significant good manufacturing practice violations, including a failure to adequately investigate failed batches and determine levels of impurities in distributed products. Read More
Drugmakers Sagent and Baxter Healthcare recently recalled products due to labeling mix-ups, a common quality problem that one expert says can be easily solved through an additional examination by personnel. Read More
Drugmaker Chimerix said it may soon start testing its broad-spectrum antiviral drug brincidofovir against the Ebola virus, after the FDA this week approved the company’s emergency investigational new drug application. Read More
PhRMA is asking a D.C. federal court to once again strike down a price discount mandated by HHS for orphan drugs, when used to treat non-rare conditions at certain covered hospitals. Read More
Endo International will acquire Auxilium Pharmaceuticals in a move that is expected to bolster Endo’s pipeline of testosterone products, which FDA advisors have recently scrutinized. Read More
Canadian generics firm Apotex has asked the full U.S. Court of Appeals for the Federal Circuit to rehear a case alleging brandmaker UCB’s hypertension drug Univasc infringed on one of Apotex’s patents. Read More
Indian authorities are reminding clinical investigators that trial applications must include information on the unmet medical need and risk-benefit assessments of the proposed drug, as well as comparisons of the innovator product and existing options. Read More