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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

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
• By Vibha Sharma

The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

More from Product Reviews

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.