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BD Secures the US FDA’s 510(k) Clearance and European CE-IVDR Certification for Enteric Bacterial Panels (EBP) on the BD COR System
Shots: BD has received 510(k) clearance & CE Mark for its EBP & EBP plus panels on the BD COR System to detect gastrointestinal bacterial pathogens from a single stool swab using PCR-based testing EBP detects multiple enteric bacterial pathogens, incl. Salmonella, Campylobacter (jejuni, coli), Shigella/Enteroinvasive E. coli, & Shiga toxin-producing E. coli, while EBP plus…
November 4, 2025
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
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