Purepac Pharmaceutical: Company is keeping its names and product label although its parent company, Purepac, Inc., will change its name to Faulding, Inc. after completing the acquisition of three companies from its majority stockholder, the Australian firm F.H. Faulding & Co., Ltd. Those acquisitions should provide Purepac label customers with a broader range of pharmaceutical products, Purepac, Inc. says...
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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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European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines 30th anniversary.
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.
Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.