Barrows Research Group and Rotta Research Laboratorium announced NDA filing for the fourth generation anti-ulcer/ulcer disease modifying drug. Barrows reported that multicenter clinical studies in West Germany found "proglumide resulted in a significantly larger proportion of endoscopically healed patients" than both pirenzepin (94% v. 65%) in duodenal ulcer patients and cimetidine (83% v. 52%) in gastric ulcer patients. Proglumide, developed by Rotta Research, has been marketed over 10 years in 72 countries.
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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 the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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