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Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease
NEWS

Eisai and Biogen Seek Japanese PMDA Approval for Leqembi SC (Lecanemab) to Treat Early Alzheimer’s Disease

Shots: The Japanese PMDA has received NDA for Leqembi SC autoinjector to treat adults with early Alzheimer’s disease (AD) NDA is supported by sub-studies from the P-III (Clarity AD) OLE study in pts with mild cognitive impairment due to AD or mild AD dementia, showing that Leqembi (500mg, SC: two 250mg injections) administered QW, provided exposure equivalent to Q2W IV…
November 28, 2025

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Celltrion
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Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives Health Canada Approval to Treat Multiple Retinal Diseases

Shots: Health Canada has approved Eydenzelt, a biosimilar version of Eylea (aflibercept 2mg), in both vial & PFS presentation for all the indications of the reference product Approval was based on extensive analytical, nonclinical, & clinical data, incl. a global 52wk. P-III trial of Eydenzelt vs Eylea in 348 pts with diabetic macular edema, which met…
November 28, 2025

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Celltrion
NEWS

Celltrion Reports Post-Hoc Analysis of P-III (LIBERTY-CD) Trial of Zymfentra (Infliximab-dyyb) in Crohn’s Disease Across Disease Locations

Shots: Celltrion has reported post-hoc analysis of the P-III (LIBERTY-CD) study of Zymfentra (infliximab-dyyb; SC) vs PBO in pts with mod. to sev. Crohn's disease, which has been published in the Clinical Gastroenterology and Hepatology Among 329 pts, 52.6% had colon-dominant (n=173) & 47.4% ileum-dominant CD (n=105); at Wk. 54, infliximab SC showed superior efficacy…
November 27, 2025

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NEWS

Neuraxpharm and mjn-neuro to launch Episeras for Early Detection of Epileptic Seizures

Shots: Neuraxpharm & mjn-neuro will launch Episeras for real-time early seizure detection in ambulatory & homecare settings, with EU rollout planned for the H2’26 EPISERAS is being evaluated in the ongoing multicentre SERAS-Home_RWD study across Spain, the UK, & Germany, with interim data currently in preparation for publication Episeras is a non-invasive device that monitors…
November 27, 2025

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NEWS

Cothera Bioscience’s Zotiraciclib Receives the US FDA Fast Track Designation for Recurrent IDH-Mutated High-Grade Glioma

Shots: The US FDA has granted FTD to zotiraciclib (ZTR/TG02) for the treatment of pts with recurrent high-grade gliomas (rHGG) harboring IDH1 or IDH2 mutations (IDHmut rHGG) Designation was backed by the completion of the P-I trial of zotiraciclib, showing preliminary efficacy & favorable safety as a monotx. in IDHmut rHGG pts, which was presented at…
November 27, 2025

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Novo-Nordisk
NEWS

Novo Nordisk Reports the US FDA’s sNDA Submission for Higher Wegovy Dose for Weight Management

Shots: The US FDA has received an sNDA for a higher dose of Wegovy (7.2mg semaglutide) along with lifestyle intervention for chronic weight management in adults with obesity, with sNDA to be reviewed under CNPV program sNDA was supported by 72wk. STEP UP trial assessing Wegovy (7.2mg, QW) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 obese…
November 27, 2025

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NEWS

GE HealthCare Reports the FDA Premarket Authorization of Pristina Recon DL for Mammography

Shots:  The US FDA has granted PMA to Pristina Recon DL, enabling the integration of deep learning with iterative reconstruction to deliver high-quality digital breast tomosynthesis (DBT) images without increasing patient radiation dose Pristina Recon DL utilizes 2 sequential deep learning models to separate signal from noise, with the first model reconstructing high-fidelity 3D volumes…
November 27, 2025

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Zoetis
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Zoetis’ Lenivia (Izenivetmab) Receives the EC Approval for Osteoarthritis Pain Relief in Dogs

Shots: The EC has approved Lenivia (Q3W) for the reduction of pain associated with osteoarthritis in dogs Lenivia showed increased mobility & decreased pain after a single administration in a 9mos. field study, along with favorable safety in dogs Lenivia, a monoclonal antibody targeting NGF, is designed to provide longer-lasting pain relief in osteoarthritis by…
November 27, 2025

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