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Manifold Bio Partners with Roche to Develop BBB shuttles for Neurological and Neurodegenerative Diseases
Shots: Manifold has entered into a strategic research collaboration & licensing deal with Roche to develop multiple next-gen blood-brain barrier (BBB) shuttles for neurological & neurodegenerative diseases, leveraging Manifold’s shuttle portfolio & mDesign AI-driven in vivo discovery platform As per the deal, Manifold will lead research & discovery of BBB shuttles for Roche’s therapeutic payloads,…
November 4, 2025
TransThera Sciences Inks Up to $881.5M Deal with Neurocrine Biosciences to Advance NLRP3 Inhibitors
Shots:   TransThera Sciences has entered into a royalty-bearing patent assignment & research collaboration deal with Neurocrine Biosciences to develop preclinical NLRP3 inhibitors for multiple diseases As per the deal, Neurocrine will gain exclusive ex-Greater China rights to develop, manufacture & commercialize NLRP3 inhibitors from TransThera’s NLRP3 portfolio, while TransThera will retain Greater China rights (Mainland,…
November 4, 2025
Alvotech Provides Update on BLA of AVT05 (Biosimilar, Simponi)
Shots: The US FDA has issued a CRL related to the BLA for AVT05, a biosimilar version of Simponi (golimumab), in PFS & autoinjector formulations The CRL noted certain deficiencies from the FDA’s Jul 2025 pre-license inspection of Alvotech’s Reykjavik facility that must be resolved before AVT05 BLA approval, though no other issues were found,…
November 3, 2025
Belite Bio Reports the MHRA’s CMA Application Acceptance for Tinlarebant to Treat Stargardt Disease
Shots: The UK’s MHRA has accepted a conditional marketing authorization (CMA) application for Tinlarebant to treat Stargardt disease CMA was based on the interim results from P-III (DRAGON) trial assessing Tinlarebant vs PBO in 104 adolescents with Stargardt disease across 11 jurisdictions, incl. the US, UK, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan,…
November 3, 2025
Daiichi Sankyo
Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC
Shots: Daiichi Sankyo has dosed the first patient with Enhertu in combination with Keytruda in the P-III (DESTINYLung06) trial as a 1L treatment for unresectable, LA/M HER2 overexpressing & PD-L1 (TPS<50%) non-squamous NSCLC Trial will assess Enhertu (5.4mg/kg) + Keytruda vs Keytruda + Pt-based CT + pemetrexed as the 1L treatment in the mentioned pts…
November 3, 2025
4D Molecular Therapeutics Collaborates with Otsuka Pharmaceutical to Develop and Commercialize 4D-150 in the APAC Region
Shots: 4DMT has granted Otsuka exclusive rights to develop & commercialize 4D-150 for retinal vascular diseases, incl. wet age-related macular degeneration (wet AMD) & diabetic macular edema (DME) in Japan, China, Australia & other APAC markets, while retaining rights in other regions As per the deal, Otsuka will lead all regulatory & commercialization efforts in…
October 31, 2025
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