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Regulatory

Latest Headlines

Latest Headlines

FDA signs off on new version of Olympus' duodenoscope amid mounting scrutiny

The FDA has signed off on a new version of Olympus' controversial duodenoscope device, days after a cadre of lawmakers came down on the agency and the company for playing down early problems with the products that were linked to superbug outbreaks in the U.S.

Congressional watchdog blasts FDA over shortcomings of postmarketing oversight IT system

The congressional watchdog has taken the FDA to task over the IT system it uses to track the safety of approved drugs. Officials at the Government Accountability Office told the FDA it should identify IT investments that will enable regulatory staffers to "easily and systematically" access postmarket data for oversight purposes.

Amgen hits a snag in its plot to challenge AbbVie's blockbuster Humira

Amgen, at work on a biosimilar of AbbVie's best-selling treatment, got an unfavorable decision from U.S. regulators that could delay the launch of its take on Humira.

Wockhardt spanked again by FDA as agency ticks off violations at new sterile injectables plant

Wockhardt saw a new plant that will make sterile injectable drugs as its best shot at restoring a U.S. business devastated by FDA product bans. But the Indian company said today that facility--a plant it has called "one of a kind in Asia"--will not be shipping to the U.S. any time soon after the FDA found shortcomings during a recent inspection to judge whether it is fit for U.S. exports.

Edwards works to expand TAVR into intermediate risk, elderly patients to hit $5B market

Edwards Lifesciences estimated the transcatheter aortic valve replacement (TAVR) market as worth more than $5 billion by 2021. That's based on its expectation of an expansion into elderly and intermediate-risk populations. Last year, its Sapien 3 valve was approved by the FDA specifically for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis.

FDA delays decision on Heron's twice-rejected nausea drug

Heron Therapeutics, pushing to finally win approval for a long-delayed treatment for chemotherapy-induced nausea, will have to wait another month or so as the FDA has put off its plans to weigh in this week.

Merck reaches $830M settlement in long-running Vioxx litigation

Merck is closing a chapter in its seemingly never-ending saga for its painkiller Vioxx, agreeing to pay more than $800 million to settle a lawsuit over the med years after the company pulled its product from the market and shelled out billions to resolve additional suits.

UPDATED: Sarepta shares crash on a harsh FDA review of Duchenne's drug

Sarepta's quest to gain an accelerated approval for eteplirsen was subjected to some harsh scrutiny by regulators at the FDA. And the insiders concluded that much of the data submitted for an approval was a mess, with weak, inconsistent data raising serious questions about the efficacy of the drug.

Wockhardt-made drug in U.S. FDA recall action

U.S.-based distributor PD-Rx Pharmaceuticals has been asked to recall more than 60,000 bottles of bacterial infection treatment azithromycin tablets made by Mumbai-based Indian drugmaker Wockhardt, the Economic Times reports.

China says varied strains of bird flu on the rise

Officials in China said at least three strains of bird flu, including H5N1, H7N9, and H5N6, have been detected in various provinces. Some patients are in critical condition, and at least two deaths have been caused.
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