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How CAR-Ts Are Changing The Lifecycle Paradigm For ATMPs

 
• By Vibha Sharma

CAR T-cell therapies have resulted in the industry and regulators exploring unconventional approaches to collecting real-world safety and efficacy data from existing registries. Can this approach also work for other types of cell and gene therapy products in the future? Delegates at a conference in London explored the topic.

3d illustration of T cells or cancer cells
Existing Registries Can Be Used For Postmarket Studies On CAR-Ts • Source: Shutterstock

The advent of chimeric antigen receptor (CAR) T-cell therapies – regulated as advanced therapy medicinal products (ATMPs) in the EU – is breaking many classical paradigms of drug development and approval and could change the way that companies, regulators and health technology assessment bodies make decisions in the future.

Although the lifecycle management of medicinal products is a long-standing regulatory requirement, it has taken on a new level of...

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More from Europe

HTA Expert Warns of Escalating Measures if Pharma Fails to Tame Prices

 
• By Francesca Bruce

Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.

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.

EU Tests Unified Pathway For Combined Drug/IVD Studies

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.

More from Geography

BIO Notebook: PRVs Need To Be A Priority, IPO Window Shut And Focusing On Gene Therapy Safety

 
• By Mandy Jackson and Sarah Karlin-Smith

Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.

Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
• By Dean Rudge

Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.