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The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More
Australia’s Therapeutic Goods Administration (TGA) has set a September deadline for companies to adopt a common technical document format for OTC regulatory submissions. 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 one bottle of the drug contained 50 mg metoprolol tartrate tablets instead of the intended drug. Read More
A UK coalition of drugmakers and a cancer research group are launching an analysis of failed Phase III lung cancer drug trials that will search for treatments that, despite failing overall, are effective for certain subpopulations. Read More
Israeli drugmaker Teva announced Thursday it has reached a settlement with Pfizer to hold back marketing generic Celebrex (celecoxib) in the U.S. until December. Read More
U.S. and EU regulators have both determined that Boehringer Ingelheim’s volasertib for acute myeloid leukemia is an orphan drug, the German drugmaker said Thursday. Read More
The European Medicines Agency will publish a guideline next year specifying how drugmakers will have to code and share medication errors with regulators. 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
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