1. Pink Sheet
  2. >>Geography
  3. >>Europe

EMA’s Cancer ‘Pathfinder’ Project Targets Conditional Approvals, Endpoints & RWE

 
• By Ian Schofield

This second of a two-part article on the EU’s “Cancer Medicines Pathfinder” initiative looks at the trade-off between the benefits and risks of conditional drug approvals and differing perceptions of progression-free survival as a validated endpoint in cancer drug trials.

Cancer Diagnosis and disease detection or screening as a treatment for malignant cells with a biopsy or testing with a cancerous cell as an immunotherapy symbol
The EMA is targeting the development of drugs for cancer • Source: Shutterstock

Among the aims of the European Medicines Agency’s “Cancer Medicines Pathfinder” initiative are to gauge how far regulators are willing to accept the uncertainties associated with the EU’s conditional marketing authorization system, and to contribute to the ongoing debate over the use of endpoints in cancer treatment.

Also in the pipeline is a study to garner views on the use of real-world evidence in approval applications for...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 
• By Eliza Slawther

The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

Ireland Could Follow France And Italy With Mandated Pharma Payment Disclosure

 
• By Francesca Bruce

Ireland’s current voluntary system for disclosing pharmaceutical company payments to health care professionals and organizations is flawed and does not adequately deal with conflicts of interests, according to an Irish law maker.

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 
• By Eliza Slawther

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”

More from Geography

COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes

 
• By Sue Sutter

New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.

Medicare’s Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

 
• By Cathy Kelly

The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 
• By Eliza Slawther

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”