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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
The Justice Department’s crackdown on drugmakers that violate the False Claims Act continues, with Astellas’ U.S. division paying $7.3 million to settle claims it improperly marketed Mycamine. Read More
The European Medicines Agency is urging healthcare providers to inspect vials of the cancer drug Herceptin for signs of tampering following reports that some vials of the drug were stolen in Italy, tampered with and reintroduced into the supply chain. Read More
Baxter said Wednesday that its Bax 111 treatment for Von Willebrand disease met its primary endpoint in a pivotal clinical trial, setting it up for NDA filing later this year. Read More
Glenmark Generics, U.S. subsidiary of India-based Glenmark Pharmaceuticals, has recalled a lot of generic ranitidine 150 mg tablets after a pharmacist complained that a bottle of the drug contained 50 mg metoprolol tartrate tablets instead. Read More
Impax Laboratories said it has begun shipping generic Renvela tablets in the U.S. after securing a license from Genzyme to sell a specified number of bottles. Read More
The European Medicines Agency said Monday it has concluded its investigation into deficient postmarket reporting by Roche and forwarded a report to the European Commission, where penalties will be debated. Read More
A group of generic drugmakers is urging the U.S. Supreme Court to let them introduce generic versions of Teva Pharmaceutical’s Copaxone multiple-sclerosis drug next month. Read More
The UK’s National Institute for Health and Care Excellence has recommended Ferring Pharmaceuticals’ Firmagon as a cost-effective treatment for advanced hormone dependent prostate cancer in people with spinal metastases and signs or symptoms of spinal cord compression. Read More
Drugmakers should include information for all uses of a product — including off-label uses — when preparing periodic benefit-risk evaluation reports, the International Council on Harmonisation says in new Q&A guidance. Read More
The FDA has approved another under-the-tongue hay fever treatment, putting a second product on the market that will replace the routine injections currently prescribed to control symptoms. Read More