Merck Rotateq pricing: CDC estimates the cost-effective ceiling for a three-dose vaccination series of Merck's pending rotavirus vaccine is $67, the agency reported to its Advisory Committee on Immunization Practices Oct. 27. Merck has not set a price for the vaccine, but said it is committed to a level that will assure widespread use and availability. CDC predicts cost-effectiveness of a routine vaccination schedule for Rotateq would be in the same range as Sanofi-Aventis' meningococcal vaccine Menactra. ACIP's rotavirus vaccine working group is recommending universal administration of three doses of the vaccine at two, four and six months of age. Merck expects approval of Rotateq in early 2006. GlaxoSmithKline said it is in discussions with FDA about licensing its rotavirus vaccine Rotarix in the U.S...
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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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While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.