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.’
Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.
After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
