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NEWS

Neurona Therapeutics’ NRTX-1001 Secures the EMA’s Priority Medicines (PRIME) Designation for Drug-Resistant Focal Epilepsy

Shots: The EMA has granted PRIME designation to NRTX-1001 for adults with drug-resistant focal epilepsy, based on preclinical & emerging clinical data NRTX-1001 is also being evaluated in 2 ongoing P-I/II trials for drug-resistant unilateral & bilateral mesial temporal lobe epilepsy (MTLE), with P-III (EPIC) trial planned to begin in H2’25 for drug-resistant MTLE The…
November 6, 2025

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Averoa Receives the MHRA’s Approval for Xoanacyl to Treat Chronic Kidney Disease (CKD)

Shots: The UK’s MHRA has approved Xoanacyl (ferric citrate complex) for the treatment of concomitant elevated serum phosphorus & iron deficiency in CKD adults via International Recognition Procedure (Route B), following EC’s approval in Jun 2025 In Dec 2022, Averoa obtained an exclusive license from Akebia Therapeutics to develop & commercialize Xoanacyl in the EEA,…
November 6, 2025

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Ailux Collaborates with Eli Lilly to Accelerate Bispecific Antibody Development

Shots: Ailux (XtalPi’s subsidiary) has entered into a strategic platform-based collaboration with Eli Lilly to accelerate the discovery & development of bispecific antibodies (bsAbs) for various diseases As per the deal, Lilly will nominate an undisclosed number of target pairs for bsAb design & may license Ailux’s platform for internal use. In exchange, Ailux will…
November 6, 2025

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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

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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

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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

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