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Deal Watch: BMS To Tap Early-Stage Breakthroughs In Partnership With BioMotiv

Bristol-Myers Squibb will partner with the biotech accelerator to fund and launch biotechs, with the pharma getting an option to buy. Novartis signs another agreement with IFM months after buying its IFM Tre affiliate.

Deals Business Strategies

Fresh Or Frozen? Orchard Aims For Cryopreserved Gene Therapy Approvals Using Pivotal Trials With Fresh Cell Formulations

Orchard aims to submit three ex vivo autologous gene therapies for approval by the end of 2021, helped by a new regenerative medicine advanced therapy designation (for a rare primary immunodeficiency syndrome) and a breakthrough therapy designation (for another rare primary immunodeficiency).

Drug Approval Standards Gene Therapy

Gene Therapy: Industry Seeks Greater Clarity In Final FDA CMC Guidance On INDs

Industry asks the US FDA to refine the focus of draft guidance on the chemistry, manufacturing and controls information that should go into investigational new drug applications for gene therapies. Questions center on a scope that ranges from CTD to GMP, from in vivo to ex vivo, and from IND to BLA.

Manufacturing Quality

Deal Watch: Denali Partners With Sirion To Take On The Blood-Brain Barrier

Denali will collaborate with Sirion in Parkinson’s and Alzheimer’s diseases. Meanwhile, Lundbeck and Elevian unveil drug development partnerships with technology firms at the J.P. Morgan meeting.

Deals Business Strategies
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