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RegeneRx Biopharmaceuticals’ dry eye candidate RGN-259 missed its primary endpoints in a Phase 2/3 trial, failing to show statistically significant improvements in either total ocular discomfort or total corneal fluorescein staining. Read More
Clovis Oncology is stopping development of the lung cancer candidate rociletinib after the FDA warned the company of a potential complete response letter. Read More
The UK’s National Institute for Health and Care Excellence is backing cholesterol-lowering drugs from Sanofi and Amgen, provided the companies deliver discounted prices as promised. Read More
Valeant Pharmaceuticals International has established a drug pricing committee, a move that comes a week after company representatives pledged to review its pricing model in the face of withering congressional criticism. Read More
Four Senate GOP HELP committee members have penned a letter to FDA Commissioner Robert Califf complaining about the agency’s handling of draft guidances. Read More
There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause production headaches for U.S. drugmakers partnering with these facilities. Read More