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Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended. Read More
A federal judge last week denied PhRMA’s request to vacate HHS’s recently modified rule requiring drugmakers to offer steep discounts on some orphan drugs sold to hospitals that serve the poor. In turning down the request, the judge also told the trade group that it must file a new lawsuit to pursue its claims against the department. Read More
Cancer drugmaker OncoMed expects to resume enrollment and dosing of new patients for its experimental oncology drug vantictumab within the next few weeks, after the FDA removed a partial clinical hold on its clinical trials. Read More
The FDA has added flow charts and removed references to the now-defunct CDER Fax-On Demand system in its updated policy on how the agency goes about posting approval letters for new NDAs, ANDAs, BLAs and supplements. Read More
Beleaguered Indian generics maker Wockhardt has initiated a voluntary Class II recall of 11,661 bottles of metoprolol succinate, a generic version of AstraZeneca’s blood pressure drug Toprol-XL. Read More
Generics manufacturers Mylan, Momenta and Sandoz have joined Dr. Reddy’s Laboratories as some of the first to announce patent challenges against Teva’s blockbuster multiple sclerosis drug Copaxone in the newer 40 mg version. Read More
Eli Lilly and Takeda Pharmaceuticals have lost their appeal to reverse a combined jury award of $9 billion in punitive damages for hiding bladder cancer risks associated with their diabetes drug Actos, but experts say that verdict will likely be reduced. Read More
The Therapeutic Goods Administration is looking to Europe for guidance on drug development, including clinical development of biosimilar drugs, investigations of lipid disorder therapies and evaluations of bacterial infections. Read More
The FDA has stepped up its enforcement of compounding pharmacy quality violations that occurred before a new law took effect that boosted agency powers, a move that some industry players contend is unjust. Read More
A former FDA employee plans to press forward with efforts to remove Lasik eye surgery devices from the market following the agency’s denial of his citizen petition seeking the ban. Read More