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Watching The Review Clock: Are US FDA Goal Date Extensions Reason For Optimism?

 
• By Bridget Silverman

Novel agents that received three-month user fee goal date extensions have a slightly higher approval rate than novel applications overall.

Stopwatch (shutterstock_157284068)
• Source: Shutterstock

Biogen, Inc. and Eisai Co., Ltd.’s announcement of a three-month extension to the PDUFA goal date for the potential Alzheimer’s disease therapy aducanumab cast a spotlight on what is usually a fairly mundane regulatory event: a three-month extension to the goal date.

Analysts greeted the 29 January 2021 announcement of the new 7 June target with a degree of optimism, noting that the agency could have simply issued a complete response letter...

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• By Sue Sutter

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EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

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• 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.

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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 
• By Neena Brizmohun

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

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.