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Sandoz’s biosimilar of Amgen’s Enbrel has received a recommendation of approval from an FDA advisory committee, making it the second biosimilar to earn recommendation within a 24-hour period.
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The FDA and the European Medicines Agency have formed a new working group focusing on incorporating patient perspectives into drug development, evaluation and post-marketing activities. Read More
The Association of the British Pharmaceutical Industry has suspended Astellas UK from the trade group, citing “serious breaches” of the group’s Code of Practice for the Pharmaceutical Industry. Read More
When given the opportunity to use real-world data and adaptive trial designs to secure marketing authorization, drug sponsors often struggle to develop innovative approaches. Read More
The introduction of biosimilars to certain European countries has lowered drug prices by 50 percent to 60 percent in certain therapy areas, a report says. Read More
China has released details of a pilot program that extends drug product licensing to domestic research and development institutions and their personnel. Read More
The FDA is accusing two Chinese API manufacturers of doctoring laboratory results, with one cited for falsifying lab reports and the other for running both official and unofficial tests. Read More