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Latest From University of Colorado
Deal Watch: AbbVie Offloads Three Cystic Fibrosis Candidates To Sionna
Plus deals involving Abeona/Beacon, TuHura/Kintara, Crosswalk/Codexis, Lantheus/Life Molecular Imaging as well as tech transfer agreements and small deals involving Pfizer, Sanofi and Ipsen.
Cancer, Gene Therapy Top US FDA’s Second Half 2024 User Fee Calendar
Novel agents in immuno-oncology headline the drug center’s upcoming goal dates, while gene therapies make up most of the biologic center’s workload.
Getting To Global Is A Hurdle For Cell And Gene Therapies
Only three of the 10 new therapies approved by the US FDA also have been approved in the European Union, while both of the EU gene therapy approvals followed FDA clearance, a Pink Sheet analysis shows.
Accelerated Approval: Withdrawing Gene Therapies Could Be Easier Than Small Molecules
The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.
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