After well-publicized problems in Johnson & Johnson’s devices and consumer health divisions, in the words of a recent Deutsche Bank research note, “It’s pharmaceuticals’ time to shine.” Indeed, the diversified health care company expects to file 11 new drugs and over 31 line extensions by 2015. Though growth is now expected from J&J’s pharma business, less well understood is the role of biologics, both marketed and near to market, in driving that expansion and J&J’s increased focus on specialty products.
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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.’
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
