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A federal judge has tossed out UK-based Reckitt Benckiser Pharmaceuticals’ patent infringement lawsuit against BioDelivery Sciences International over its competing product to Reckitt’s Suboxone, ruling that the court didn’t have jurisdiction because BioDelivery’s drug has yet to be approved. Read More
Manufacturers that are slow to report overpayments for drugs reimbursed through federal healthcare programs, such as Medicare or Medicaid, could face fines of $10,000 a day, under a proposed regulation — a rule that could cause major headaches for drugmakers trying to sort out complex government billing systems. Read More
Pfizer suffered a setback Tuesday in its efforts to defend itself against charges that a division of the company illegally slowed generic competition for one of its products. Read More
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Generic manufacturers are unlikely to be pleased with final draft guidance from the FDA on ANDA stability testing that continues to insist on six months of long-term stability data.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