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Indian drugmaker Lupin Pharmaceuticals is voluntarily recalling three lots of its flagship cephalosporin oral antibiotic Suprax after the drug failed to meet specification in total impurities at the nine-month stability mark. 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
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
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
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