Docosanol 10% cream NDA (20-941) deemed "approvable" by FDA in May 30 letter. Final approval is expected in the third quarter after minor labeling issues are worked out, Avanir President and CEO Gerald Yakatan, PhD, says during a June 1 conference call. A proposed Rx version of the cream initially was determined "not approvable" by FDA due to missing data from a European trial and labeling concerns. The cold sore product will be marketed by SmithKline Beecham under a licensing agreement with San Diego-based Avanir. The introduction of the docosanol cream, expected to occur roughly six months after labeling is approved, will give SB another avenue into the OTC market. So far, SB has been unsuccessful in its attempts to switch its Rx cold sore drug Denavir (penciclovir) to OTC status
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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Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022.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.
