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NEWS

argenx Receives Health Canada’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Shots: Health Canada has approved Vyvgart (efgartigimod alfa; QW, SC, PFS) as a monotx. for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) Approval was based on the ADHERE trial, showing 69% (221/322) of Vyvgart SC-treated pts had clinical improvement, regardless of prior treatment. The study met its 1EP with a 61% reduction in relapse risk vs…
November 6, 2025

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Aqua Medical Receives the US FDA IDE Approval to Initiate Trial for Ablation Procedure to Treat Uncontrolled Type 2 Diabetes

Shots: Aqua Medical has received the US FDA IDE approval to initiate the RESTORE-1 study evaluating the Proximal Intestinal Mucosal Ablation (PIMA) procedure using its radiofrequency vapor ablation (RFVA) system in adults with uncontrolled type 2 diabetes The IDE approval was backed by international data showing safety & metabolic benefits of PIMA, allowing Aqua Medical…
November 6, 2025

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AmacaThera Inks a ~$230M Exclusive Global Licensing Deal with Pacira BioSciences to Advance AMT-143

Shots: AmacaThera has entered into an exclusive global license agreement with Pacira to develop & commercialize AMT-143, a long-acting non-opioid anesthetic, leveraging AmacaThera’s tunable hydrogel platform to treat post-operative pain As per the deal, AmacaThera & Pacira will jointly advance AMT-143, with AmacaThera leading select clinical studies & Pacira funding development through commercialization. In exchange, AmacaThera…
November 6, 2025

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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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