Graceway licenses derm compounds from Pfizer: In Pfizer's first out-licensing transaction since announcing its merger with Wyeth in January, the pharma is selling worldwide commercial rights and related intellectual property to three investigational dermatology candidates to Graceway Pharmaceuticals. Financial terms were not disclosed. Pfizer said the deal is part of its "plan to out-license R&D programs that are no longer core to its strategy." Privately held Graceway gains two Phase II programs for treatment of oily skin and acne - an SCD1 inhibitor and an ACAT inhibitor - along with a preclinical ALK-5 inhibitor for reduction of surgical and traumatic scars. In addition to dermatology, Graceway also markets drugs in the respiratory and women's health areas
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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 Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.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.
