We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Swiss drugmaker Novartis said it would give New York City-based Ophthotech Corp. up to $1 billion to license its experimental eye drug Fovista outside of the U.S. Read More
A Citizen Petition from law firm Hyman, Phelps & McNamara contends the FDA should revoke Ranbaxy’s first-to-file market exclusivity status on several lucrative generic drugs due to a clear history of manufacturing problems and intentional false statements made by the Indian generics company. Read More
Generic manufacturers are unlikely to be pleased with final draft guidance from the FDA on ANDA stability testing that continues to insist on six months of long-term stability data. Read More
Specialty pharmaceutical firm Actavis has reached a deal to market generic versions of Valeant Pharmaceuticals’ acne-treating Acanya Gel, as well as its hypertension drug Tiazac, under a patent settlement agreement announced May 12. Read More
A federal appellate court has ruled in favor of Sanofi-Aventis’s defense of its combination hypertension drug Tarka, finding that there was nothing “obvious” about its patent on the product. Read More
Abbott Labs is poised to double its presence in generic pharmaceuticals in Latin America with a planned purchase of Chile-based generics manufacturer CFR Pharmaceuticals, the companies announced May 16. Read More
The FDA blasted generic drugmaker Alvogen for its promotion of the alcoholism treatment disulfiram that omitted potentially life-threatening risks. Read More
Novartis has gained an extra seven months of marketing exclusivity on its blockbuster leukemia drug Gleevec in a settlement with Sun Pharma that permits the Indian manufacturer to launch a generic version of the drug in the U.S. as early as Feb. 1, 2016, the firms said May 15. Read More
The FDA’s proposal to give generic manufacturers the same labelling authority as brand manufacturers is nothing short of “illegal,” argue two prominent FDA observers. Read More