Zila v. Colgate: Firms resolve out-of-court suit concerning Colgate's alleged infringement of Zila's patent for Zilactin medicated gel for mouthsores. Terms of the settlement were not disclosed. Zila noted that it has spent over $1 mil. in legal fees and related costs; "We are pleased to see the end of this financial drain on the company's resources," the firm said. Zila filed the complaint in 1994. The Zilactin line also includes Zilactin-L liquid for external sores, Zilactin-B with benzocaine, Zilactin-Lip medicated lip balm with SPF 24 and new Zilactin-Baby for teething...
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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.’
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 Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.
Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.
