Bextra Contraindicated In CABG Surgery Patients
Labeling change to add "black box" for serious skin reactions incorporates post-surgery safety data, including results from two coronary artery bypass graft trials that show increased cardiovascular risk with Pfizer's COX-2 inhibitor.
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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.’
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The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.
Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.