Perrigo files an abbreviated new drug application for a generic equivalent of the heart burn reliever Zegerid OTC, drawing a patent infringement suit from Schering-Plough HealthCare Products filed Sept. 20 in the U.S. District Court of New Jersey. Perrigo notes a federal court in Delaware ruled earlier this year in a similar suit that the same patents were invalid due to obviousness (1"The Tan Sheet" April 19, 2010). An appeal is pending in the Delaware case, which is related to Zegerid prescription products. Perrigo said in a Sept. 24 release that it notified Schering-Plough prior to filing the ANDA for the omeprazole 20 mg /sodium bicarbonate 1,100 mg drug. The private labeler cites data from Chicago-based IRI Symphony that places sales of Zegerid OTC at about $60 million annualized in the most recent month
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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 Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
