Third Time Lucky for Roche’s Polivy in Europe?

It’s decision time again at the European Medicines Agency and Roche’s Polivy is one of the new drug applications that is up for a potential marketing recommendation.

Archery_Target
Will Roche hit the target this time round? • Source: Shutterstock

 Editor's note: This article was updated on 15 November 2019 to reflect that the MAA for Polivy did not in fact reach the stage at the July meeting of the CHMP of being up for an opinion on whether it should be recommended for marketing in the EU. 

The European Medicines Agency’s drug evaluation committee, the CHMP, will this week consider again whether polatuzumab vedotin, Roche/Genentech’s new orphan...

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

More from Product Reviews

More from Pink Sheet

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy

 
• By 

Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."

World’s First Hemato-Oncology Microbiota Therapeutic Among Latest New EU Filings

 

The European Medicines Agency has started reviewing for potential EU marketing approval six new products, including MaaT Pharma’s microbiota therapeutic for acute-graft-versus-host disease, and AstraZeneca's camizestrant for locally advanced or metastatic breast cancer.