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.’
The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.
Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
