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.
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.
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.
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.
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.
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.
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.
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.
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, 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.