Topic:

Regulatory

Latest Headlines

Latest Headlines

South Korea's Samsung Bioepis gets EU nod for Enbrel biosimilar

South Korea's Samsung Bioepis won European Commission approval for commercial sales of a biosimilar of Amgen's Enbrel, marking a first that will make its version of the rheumatoid arthritis treatment available across the European Union as well as Norway, Iceland and Liechtenstein.

Indian Council of Medical Research hopes to spur clinical trial upswing

The Indian Council of Medical Research wants a greater push on clinical trials of existing medicines used to treat tuberculosis, malaria and cancer among other prevalent diseases in the country to stem a noticeable decline in overall clinical work in those areas in the past three years.

Sanofi may get waiver from large-scale dengue vaccine trials in India

A waiver of large-scale clinical trials for Sanofi's dengue vaccine, Dengvaxia, was recommended by a special committee that advises the Drug Controller General of India, the Economic Times reports.

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.
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