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 remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
The US Medicare Payment Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.
