Topic:

Regulatory

Latest Headlines

Latest Headlines

DOJ slaps Olympus with a subpoena over dirty duodenoscopes

The U.S. Department of Justice subpoenaed Olympus Medical Systems in the latest portion of the long-unfurling saga of how and why duodenoscopes routinely used in colonoscopies and upper gastrointestinal tract examinations have continued to be a problematic source for the spread of deadly bacteria for years.

Court grants Amarin long-awaited Vascepa exclusivity

Amarin has finally grabbed the 5-year marketing exclusivity for fish oil pill Vascepa that it's long been seeking.

Zimmer to divest three U.S. businesses to appease FTC, hit mid-June Biomet acquisition close

Zimmer already has clearances from regulators in Europe and Japan for its proposed $13.4 billion acquisition of Biomet. Now it's close to gaining the go-ahead from the U.S. Federal Trade Commission. Zimmer has disclosed that it has secured buyers for three U.S. businesses to satisfy FTC requests: Zimmer Unicompartmental High-Flex Knee System assets, Biomet Discovery Elbow System assets and Cobalt bone cement assets.

Merck hands its hep C combo to the FDA with sights on Gilead and AbbVie

Merck, working to scratch out a place in the market for next-generation hepatitis C cures, filed its new combination treatment for FDA approval in hopes of taking third place in a fast-crowding field.

FTC says Teva settlement means pay-for-delay ends, maybe

Teva Pharmaceuticals and the U.S. Federal Trade Commission reached a $1.2 billion settlement that could mean the end of pay-for-delay deals, or not. Asia generics makers selling in the United States are likely to be affected.

Untried drug candidates can find a home at Japan's newly minted AMED

The Japan Agency for Medical Research and Development, created less than two months ago in the model of the U.S. NIH, is now ready to receive up to 200,000 substance samples from more than 10 drugmakers. In exchange for providing the substances free of charge, AMED said it would work with universities and other researchers to test a substance's use in treating various diseases and ailments, such as cancer and infection.

Teva a winner as U.S. Federal Court gives thumbs down to Japan's Otsuka on novel Abilify lawsuit

A U.S. federal court ruled against Japan's Otsuka Pharmaceutical in an intricate court case involving an orphan drug, several patents and generics approvals. All of that was involved in a suit against the U.S. FDA.

Answers awaited as India plans large-scale tests of domestic drug quality

Will it get the results it wants? India's drug regulator plans to test 42,000 domestic-made drugs throughout the rest of this year to prove their quality and shake the notion that the nation's drugs are not safe or are of low quality.

WSJ: FBI probes J&J over morcellator safety risks

How much did Johnson & Johnson know about the risks of power morcellators--now suspended on safety concerns--before it pulled them from the market last year? That's the subject of a new investigation, headed up by the FBI's Newark, NJ, office,  The Wall Street Journal 's sources say.

FTC scores hefty $1.2B settlement in Teva pay-for-delay case

After pursuing a pay-for-delay case against Teva's Cephalon unit for years, the Federal Trade Commission has forced the drugmaker to hand over $1.2 billion in past profits.