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Ranbaxy’s regulatory woes deepened Thursday as the FDA prohibited the drugmaker’s Toansa, India, plant from manufacturing and distributing active pharmaceutical ingredients (APIs) for U.S. products after a poor inspection. Read More
Proposed international guidelines on metal impurities in finished drugs may be impossible to meet because they lack specificity and are impractical for suppliers, drugmakers say. Read More
Brand drugmakers are denying accusations they’re behind a covert campaign to block proposed patent law changes that would improve access to generics in South Africa. Read More
The Department of Justice wants to rid the pharmaceutical industry of pay-for-performance sales compensation packages, believing they fuel fraud, off-label marketing and other deceptive behaviors, a former top prosecutor says. Read More
The FDA has approved a new formulation of Nuvo Research and Mallinckrodt’s osteoarthritis drug Pennsaid for the treatment of osteoarthritis knee pain, but not the broader indication of signs and symptoms of the disease — adding a new wrinkle to the fight between the two partner companies co-developing the drug. Read More
Drugmakers angling for longer patent-term adjustments scored a big win Wednesday as a federal appeals court ruled that the U.S. Patent and Trademark Office (PTO) incorrectly calculated adjustments for three Novartis patents, a ruling that will affect patents across the board. Read More
French authorities in December fined Merck US $21.5 million for attempting to stall market entry of generic versions of its opioid-dependence drug Subutex. Read More
Foreign pharma can continue to invest directly in existing Indian drug companies, provided there is no “noncompete” clause in the transaction, the government says. Read More
Transparency and bribery — ying and yang — all but dominated global pharmaceutical headlines in 2013. “Sunshine” was cast on regulatory authorities and drugmakers in the U.S. and European Union. A number of industry associations and some individual companies also took steps to operate more transparently. The moves came as a major bribery scandal made waves in China, bringing pressure for more punishing antibribery rules. Meanwhile, the EU and India pushed forward with new clinical trial controls, and U.S. track-and-trace efforts advanced. With 2014’s script still a work in progress, take a look back at 2013 and use its lessons to plan your business strategy for the coming year.Read More
Drugmakers that market products in Brazil have two years to present Anvisa with a full report of traceability of at least three batches, according to a resolution published in the Dec. 11 Official Journal. Read More