Lonza Group Ltd.
Latest From Lonza Group Ltd.
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Industry asks the US FDA to refine the focus of draft guidance on the chemistry, manufacturing and controls information that should go into investigational new drug applications for gene therapies.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.
More M&A may be in store in the contract development and manufacturing space, with the founder of India’s Strides group apparently open to divesting his holding in the UK-based Sterling Pharma Solutions, at least going by what some deal street insiders say.
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