Novo Nordisk is seeking EU marketing approval to use its blockbuster obesity drug for reducing the risk of heart attack and stroke and it wants the European Medicines Agency to consider its request for an extra year of market protection.
The European Medicines Agency is discussing whether Novo Nordisk should be granted approval to extend the EU indication of its blockbuster obesity drug Wegovy (semaglutide) to include its use for reducing the risk of major adverse cardiovascular events (MACEs), and also be awarded an extra year of market protection.
The company’s application for approval of the new indication and extended market protection is listed on this week’s draft...
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.
