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Features / Comment / Insight / Analysis / Facts 

October 2024  Vol 26 Issue 8


Third application for Orion's prostate cancer drug submitted by Bayer
Finnish pharamceutical company Orion has announced that its partner Bayer is applying for a third application of its prostate, page 4

CluePoints launches Medical & Safety Review software for clinical data review
Risk-based quality management and data quality oversight software company, page 6

Biologic medicine dupixent approved by FDA for COPD patients in the US
The US Food and Drug Administration has approved Sanofi's Dupixent as an add-on for adults with inadequately controlled, page 8


FDA approves first drug in 50 years for treatment of schizophrenia in adults

Earlier this September, the US Food and Drug Administration (FDA) granted approval for Puretech Health’s KarXT for the treatment of schizophrenia in adults, triggering royalty payments of $29m to PureTech. It will be the first approved mechanism by the FDA for schizophrenia in over 50 years.

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Eric Elenko PhD, co-founder and president of PureTech said: “The FDA approva l of (KarXT) Cobenfy is a significant milestone in our mission to transform the lives of patients with devastating diseases. We are immensely proud that our dedication to this programme has led to the first major innovation in decades for those living with schizophrenia, and I am equally pleased that our unique approach to R&D has delivered yet another novel therapeutic to patients. Congratulations to the teams at Karuna and Bristol Myers Squibb on this historic accomplishment.”

PureTech Health invented KarXT – a combination of two biologically active molecules, trospium chloride and xanomeline. Its development was then furthered under PureTech’s founded entity Karuna Therapeutics. PureTech Health’s strategic royalty agreement with Royalty Pharma in March 2023, and Karuna Therapeutics’ acquisition by BMS in March 2024, generated £1.1bn for PureTech, of which $18.5m was directed towards Karuna’s founding and KarTX’s development. KarTX is now under the stewardship of BMS and will be marketed under the new name Cobenfy.