Topic:

Regulatory

Latest Headlines

Latest Headlines

Taiwan's PharmaEngine submits NDA at home for MM-398 pancreatic cancer candidate

Taiwan's PharmaEngine submitted a New Drug Application to the Taiwan Food and Drug Administration for MM-398 to treat patients with metastatic adenocarcinoma of the pancreas.

Wockhardt aims to convince investors FDA woes on path to getting fixed

It's not exactly a charm offensive, but India's Wockhardt is going out of its way to tell investors and, hopefully, the U.S. FDA that manufacturing quality woes are on the way to being fixed.

Getting better all the time for drug, medical device safety in China?

Over the weekend, China's leadership took the time to focus again on ensuring the quality of consumer goods with an underlying message for the medical device and drug industries highlighted by recent probes of top officials.

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.