Topic:

Regulatory

Latest Headlines

Latest Headlines

Redesigned scope by Japan's Olympus cleared by FDA

Japan's Olympus, which has been the target of lawsuits in the United States and investigations in Europe, caught a break from the U.S. Food and Drug Administration last week when the federal regulator approved the company's duodenoscope with design changes and changes to its labeling.

UPDATED: Unit of Singapore's Biosensors refuses U.S. FDA inspection

A unit of Singapore-based Biosensors International refused a U.S. FDA inspection request and was subsequently barred from selling its products in the United States, joining a rare list of companies in the same category.

Pressure grows for 35% margin cap for drugmakers in India

The price of drugs in India could fall soon, officials are saying, as the government continues to study a 35% cap on the trading margins of drugmakers.

EMA launches review of 'last-resort' antibiotic after scientists ID resistance gene

The 50-year-old antibiotic colistin is widely used to treat bacterial infections in both animals and people that have become resistant to other drugs. But last year, scientists in China discovered a gene called mcr-1 that makes bacteria resistant to colistin, prompting some scientists to urge regulatory agencies to issue stricter guidelines for the use of the antibiotic in farm animals.

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.