Marketing of Biogen Idec/Elan's Tysabri would not be restricted by the companies' proposed risk management plan, CDER Office of Medical Policy Director Robert Temple said during a press briefing following an advisory committee meeting on the product's reintroduction
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.
A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.
Learn how advances in vaccine adjuvants are shaping the future of global health and driving more effective immunization strategies
