Commercial Operations

FDA OK of Follow-On Osteoarthritis Drug Deepens Nuvo, Mallinckrodt Scrap

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

Pharma 2013: Transparency, Clinical Trials, Bribery Dominate the News

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