The company hopes to announce a partner for nebivolol this fall, roughly the same timeframe targeted for discussions with FDA on data needed for a congestive heart failure claim. The beta blocker is “approvable” at FDA for hypertension; Mylan expects to respond to the agency by year-end.
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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.’
Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
