Mithra’s combined oral contraceptive Estelle includes estetrol, the first compound in the contraceptive area to be designated a new active substance in Europe in over 80 years.
The European Medicines Agency is set to decide this week whether to recommend pan-EU marketing authorization for Estelle (estetrol/drospirenone), the potential blockbuster oral contraceptive from Mithra.
Estelle, which was approved for the first time worldwide this month when Canada gave it the thumbs up, marks a...
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.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
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.
