Pfizer/W-L's OTC allergy remedy produced a 54%-60% greater reduction in primary nasal allergic rhinitis symptoms than Schering's Rx antihistamine among 870 patients, Pfizer says, citing two studies comparing the remedies' effects on symptoms caused by cedar pollen and ragweed. Benadryl users experienced a higher incidence of somnolence (31.1% cedar pollen, 27.6% weed pollen) compared to Claritin users (4.4%, 4.7%). In response, Schering points to Claritin's non-sedating formula, safety and efficacy record and once-daily dosing. Claritin and other Rx antihistamines continue to be the subject of Rx-to-OTC switch talk (1"The Tan Sheet" July 3, p. 3)
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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.’
In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.
The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.
The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.
