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Industry groups are pressing for dialogue with Indian regulators after the Delhi High Court declined to stay a government order establishing price controls on formulations used in 108 nonscheduled drugs for diabetes and cardiovascular disorders. Read More
The FDA approved a new indication for Millennium Pharmaceutical’s profitable oncology drug Velcade, the latest attempt by the drugmaker to expand the chemotherapy product’s uses. Read More
McKesson agreed to pay the federal government $18 million to settle allegations the distributor improperly shipped vaccines to providers in an unusual whistleblower settlement. Read More
Janssen Pharmaceuticals will launch Invokamet in the U.S. on Aug. 18, following Friday’s FDA approval of the type 2 diabetes therapy. The product is the first fixed-dose combination of an SGLT2 inhibitor plus metformin cleared for marketing in the U.S. Read More
New Jersey-based Eisai is suing the FDA over the exclusivity clock assigned to two of its products, claiming the government arbitrarily shortened its five-year exclusivity period from generics competition. Read More
The EU’s drugs authority is advising manufacturers that routine inspections will now include a focus on compliance with pharmacovigilance reporting requirements. Serious violators will face the Pharmacovigilance Risk Assessment Committee. Read More
The FDA cited a trio of compounders for a wide swath of quality violations, igniting renewed criticism that the agency is “unjustified” in using a new law to enforce old violations. Read More
An FDA inspection of Impax Laboratories’ Taiwan plant has uncovered apparent manufacturing violations, raising new questions about the company’s plans to launch its proposed Parkinson’s disease drug Rytary. Read More
The FDA has downgraded its clinical hold on Tekmira Pharmaceuticals’ TKM-Ebola experimental RNA interference therapeutic, a move that could clear the way for the drug’s potential use in individuals infected with Ebola virus. Read More