Orchard Therapeutics Limited
http://orchard-tx.com/
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Latest From Orchard Therapeutics Limited
Marching On: Eight Novel Agents Among March Goal Dates For US FDA
Crowded calendar could bring to an end the slow start for novel approvals in 2024, as decisions come due for Lilly’s donanemab, Merck’s sotatercept, Regeneron’s odronextamab and more.
As 2024 Begins, US FDA’s Novel Agent Prospects Look A Lot Like 2023
Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.
The ‘Haves And Have-Nots’ Are Becoming Clearer In Cell And Gene Therapy
2023 saw a number of gene therapy companies go to the wall, but those that can combine clinical significance and commercial success can build sustainable businesses.
Breakthrough Bounceback Looks Unlikely At US FDA’s CDER, But CBER Is Riding Wave Of RMATs
Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.
Company Information
- Industry
- Pharmaceuticals
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Pharmaceuticals
- Drug Delivery
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Biotechnology
- Gene Therapy, Cell Therapy
- Other Names / Subsidiaries
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- Orchard Therapeutics (Europe) Limited, Orchard Therapeutics North America
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