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Latest From Lonza Group Ltd.

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Industry asks the US FDA to refine the focus of draft guidance on the chemistry, manufacturing and controls information that should go into investigational new drug applications for gene therapies.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

Strides’ Founder Considering Stake Sale In UK CDMO?

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.

M & A India

Drug Delivery Outsourcing In A World Of Pharma’s Shifting Sands

The contract drug delivery industry is facing disruptive influences from an evolving client base, the increase in biologics manufacturing and specialty pharma needs. In Vivo speaks to Catalent’s vice president of strategy, Cornell Stamoran, about the evolution of the industry and the continuous search for efficiency.

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