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With 12 nations signing off on the Trans-Pacific Partnership on Wednesday, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Read More
An FDA advisory committee gave Celltrion’s biosimilar candidate for Remicade a strong show of support Tuesday, backing its approval for six different indications in a 21-3 vote. Read More
Republicans on the Hill already are blasting the White House’s fiscal year 2017 budget, which would give the FDA about $5.1 billion, roughly $358 million more than what the agency received last year. Read More
The Senate HELP Committee on Tuesday unanimously approved seven bills as part of its biomedical innovation agenda, the upper chamber’s piecemeal version of the House’s 21st Century Cures Bill passed in July 2015. Read More
The European Medicines Agency and the European Commission today published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
Novartis is joining the emerging pay-for-performance trend, inking a deal with health insurers Aetna and Cigna for its new heart failure drug Enestro. Read More