Moment Of Truth For Daiichi/AstraZeneca’s Enhertu In EU

The EU marketing application for the HER2-targeted antibody drug conjugate has been fast-tracked and is now up for an opinion from the European Medicines Agency.

Concept of national healthcare system - EU - European Union
EU regulators are deciding whether trastuzumab deruxtecan should be approved • Source: Shutterstock

Daiichi Sankyo and AstraZeneca could find out this week whether the European Medicines Agency will recommend that their drug, trastuzumab deruxtecan, should be granted pan-EU marketing approval for treating unresectable or metastatic HER2-positive breast cancer.

More from Product Reviews

More from Pink Sheet

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.