Business In Brief
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.’
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Pharmaceutical companies need to “pressure test” their clinical development strategies early for health technology assessment purposes, particularly in light of the new EU HTA Regulation, a life sciences consultant says.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.