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Valeant Pharmaceuticals is defending its business relationship with specialty pharmacy Philidor RX Services against allegations Valeant used it to inflate financial results. Read More
In a conflicted decision with most members suggesting postmarketing studies, an FDA advisory panel voted 10 to four Friday to recommend approval of AstraZeneca’s gout drug lesinurad. Read More
The FDA and European Medicines Agency took differing views on multiple melanoma injections up for approval, with the U.S. agency rejecting Spectrum Pharmaceuticals’ Evomela and the EMA’s scientific experts recommending approval of Amgen’s Imlygic. Read More
The FDA Friday approved Alexion Pharmaceuticals’ Strensiq for the first-ever treatment of hypophosphatasia, a rare genetic metabolic disorder that weakens bones. Read More
FDA’s Office of Manufacturing Quality will now be involved in evaluating all BLAs and supplements to ensure product quality throughout a product’s lifecycle. Read More
The FDA could issue guidance on demonstrating interchangeability between a biosimilar and its reference product by the end of the first quarter of next year. Read More
A drug compounder not approved by the FDA says it is mixing pyrimethamine — the active ingredient in Daraprim — with another drug, folic acid-derivative leucovorin, at a cost of $99 per 100-count bottle to counter Turing Pharmaceuticals’ $750 per pill price on the blockbuster AIDS drug. Read More
Drugmakers facing a European GMP inspection should be prepared to provide complete documentation of active ingredients throughout the supply chain, going back to the starting materials that were used in the synthesis of the APIs. Read More