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Janssen’s BCMA-Targeting CAR-T, AstraZeneca’s Evusheld Among EU Verdict Hopefuls

 
• By Vibha Sharma

The EMA is poised to say whether or not six new drugs are on track for pan-EU approval, including Janssen’s first cell therapy and an antibody combination to prevent COVID-19 in people with poor immune response.

Multiple myeloma (cancer type) diagnosis medical concept on tablet screen with stethoscope.
Cilta-Cel is a one-time autologous treatment for multiple myeloma • Source: Alamy

Sponsors of six new drugs are set to learn this week whether their products are on track for possible EU-wide approval, including Janssen for its CAR-T therapy for multiple myeloma ciltacabtagene autoleucel (cilta-cel) and AstraZeneca for its COVID-19 preventive treatment Evusheld (tixagevimab/cilgavimab).

Cilta-cel was authorized as Carvykti in the US three weeks ago, while Evusheld was approved for emergency use in the...

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More from Approvals

EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

 
• By Eliza Slawther

There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.

New EU Filings

 
• By Neena Brizmohun

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

 
• By Neena Brizmohun

Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.

More from Product Reviews

Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

 
• By Neena Brizmohun

Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
• By Bridget Silverman

US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.