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Leaders of the House Energy & Commerce Committee are asking FDA Acting Commissioner Stephen Ostroff to explain what steps the agency is taking to address safety concerns around the blood thinner warfarin and its reference product, Coumadin. Read More
Impax Laboratories says the FDA has inspected its Hayward, Calif. manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. Read More
Concordia Healthcare is acquiring UK-based Amdipharm Mercury for $3.5 billion, in a deal that greatly expands the Canadian drugmaker’s generic portfolio and global reach. Read More
Drug and biologics makers are urging the Centers for Medicare & Medicaid Services to reimburse each noninterchangeable biosimilar based on its own average sale price, saying that would avoid prescribing mix-ups and possible harm to patient care. Read More
Yet another Indian drugmaker has been dinged for serious data integrity and GMP issues — this time during a June 4 to 7 inspection by the World Health Organization. Read More
With the last legal hurdle removed, Sandoz wasted no time launching its Zarxio biosimilar of Amgen’s chemotherapy product Neupogen nationwide — offering the first U.S. biosimilar at 15 percent below the price of its reference product. Read More
The FDA has released a final guidance allowing it to destroy certain drug imports valued at $2,500 or less that have been refused admission into the country in an attempt to boost the integrity of the drug supply chain. Read More
The FDA has banned imports of drugs made at Mumbai-India based Polydrug Laboratories, marking the latest development in ongoing issues involving Indian manufacturers. Read More
The FDA has granted Catabasis Pharmaceuticals a rare pediatric disease designation for an investigational drug used to treat Duchenne Muscular Dystrophy, paving the way for priority review, the company said Monday. Read More
The GPhA is challenging the legality of the FDA’s final guidance calling for generics makers to design tablets and capsules to be similar in size and shape to their reference drug to ensure patient acceptance. Read More
Merck KGaA has informed the European Medicines Agency that it will apply for marketing authorization for its multiple sclerosis drug Cladribine, four years after the firm withdrew its application following a negative opinion from the Committee for Medicinal Products for Human Use. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet today to discuss the safety and immunogenicity of CSL’s influenza vaccine Fluad to determine if it should be approved through an accelerated approval pathway. The vaccine is proposed for use in people 65 and older as treatment against influenza types A and B. Read More