NyQuil D behind the counter
NyQuil Dis launching with the same pseudoephedrine-containing formula as the original Nyquil, but sold behind retail counters, Procter & Gamble announces Oct. 1. Part of the Vicks cough, cold and flu line, the 10 oz. formula carries an SRP of $6.32. P&G removed PSE from Vicks products due to illicit use of the ingredient and because the Combat Meth Act prohibits OTC sales of PSE products (1"The Tan Sheet" March 6, 2006, p. 5)...
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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.’
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PharmaMar, which wants to use the Jazz Pharmaceuticals-partnered drug, lurbinectedin, in combination with Roche’s Tecentriq for treating extensive-stage small cell lung cancer, is one of two companies that this month sought an accelerated assessment of their planned EU marketing applications.
The European Medicines Agency’s chief, Emer Cooke, explained how the agency could help companies with their drug development plans, and said the EU Health Technology Assessment Regulation would help companies design clinical trials that are fit for regulators and HTA bodies.
Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdown in review work due to layoffs and other recent changes.