Lonza Group Ltd.
Latest From Lonza Group Ltd.
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.
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).
Industry asks the US FDA to refine the focus of draft guidance on the chemistry, manufacturing and controls information that should go into investigational new drug applications for gene therapies.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.
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.
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- Lonza Group Ltd.
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Richard Ridinger, CEO
Toralf Haag, CFO
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Lonza Group Ltd.
Phone: (41) 61 316 81 11
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