The Senate last week voted 64-36 to approve a budget that will protect FDA user fees from sequestration cuts for the next two years. Read More

The FDA’s new breakthrough therapy designation has exploded in popularity, the agency says. As of Nov. 22, 108 requests for breakthrough designation have been submitted. Read More

Former InterMune CEO W. Scott Harkonen’s crusade to challenge his felony conviction in a closely watched free speech case collapsed after the Supreme Court declined to hear his appeal. Read More

French authorities on Thursday fined Merck $21.5 million for its efforts to stall market entry of generic versions of its opioid-dependence drug Subutex. Read More

Amarin has received an FDA untitled letter for omitting risk information in a print promotion for its fish oil drug Vascepa, adding to a pileup of setbacks for the product. Read More

Alimera Sciences’ negotiations with the FDA on Iluvien have put the diabetic macular edema drug on a glide path to potential approval — a startling about-face following three complete response letters (CRL) for the drug’s application. Read More

Gilead Sciences’ drug Sovaldi appears primed to dominate the hepatitis C market with the release of new Phase III trial data showing subjects with genotype 1 of the virus benefit from the drug, without coupling it with interferon. Read More

GlaxoSmithKline unveiled a new compensation system for its global sales force this week in a move hailed as a revolutionary change to improve ethical practices for drug sales professionals. But so far it’s a revolution of one. Read More

The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More

The FDA has extended by 60 days the comment period for its proposed safety labeling rule for generic drugs. Stakeholders now have until March 13 to comment on the proposal, which would allow generic drugmakers to update labels in response to safety issues without agency approval. Read More