OTC CLEMASTINE DATA CAN BE GENERALIZED TO PEDIATRIC POPULATIONS for treatment of the common cold, FDA's Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees agreed at a Nov. 16 joint meeting in Rockville, MD. The committees voted 12-3 that the common cold is sufficiently similar in the adult and pediatric populations to allow the results of Sandoz' two randomized, double-blind, placebo-controlled trials to be extrapolated to children six to 12.
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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Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022.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.
