Pfizer's migraine therapy Relpax (eletriptan) clears FDA Dec. 26, becoming the seventh approved triptan. Approval was delayed while Pfizer conducted FDA-requested cardiovascular safety trials addressing safety of higher doses. FDA approved 20 mg and 40 mg single doses, but not 80 mg. The larger dose had higher response rates in five of six efficacy studies, but with more adverse events. Labeling allows for a maximum of two daily doses not to exceed 80 mg. Pfizer will launch Relpax during the first quarte
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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.’
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
