FDA’s statutory neutrality on comparative effectiveness in drug approval decisions both helped and held back Viibryd (vilazodone), now owned by Forest Laboratories. Because approval requires only that a candidate proves superiority to placebo, not to any existing treatments, the antidepressant entered a highly competitive, crowded market with statistically significant but commercially unremarkable efficacy.
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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.’
New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.
BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
