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Latest From AbbVie Inc.
Asia Deal Watch: Ono Calls On PRISM BioLab’s Capabilities
Plus transactions involving Nissan Chemical/Sanwa Kagaku, Memel/Therabest, Chugai/Alnylam, Takeda/Kumquat, Nxera/Handok, 3SBio/CStone and deals in brief.
Beyond CAR-Ts: Cell-Based Gene Therapy Sponsors Are ‘Branching Out,’ CBER’s Marks Says
As sponsors explore development in autoimmune and infectious diseases, plus a range of hematologic and solid tumors, manufacturing processes can be centralized or decentralized, but Marks says the FDA is ‘neutral’ on that decision.
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.
Teva Starts The Year With Phase III Data And Growth
Teva reported positive Phase III data for a long-acting version of olanzapine for schizophrenia, coinciding with its first quarter sales and earnings release.
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