NEWS

Imugene Collaborates with JW Therapeutics to Advance onCARlytics and Carteyva Combination in Solid Tumours

Shots: Imugene has entered into a co-development collaboration with JW Therapeutics to evaluate Imugene's oncolytic virus CF33-CD19 (onCARlytics) & JW's Carteyva for pts with advanced solid tumors The company will jointly perform preclinical in vitro & in vivo studies & will advance the combination to a P-I investigator-initiated trial conducted exclusively at CAR-T clinical centers…

November 28, 2025

Gan & Lee Pharmaceuticals Initiates P-III (GRADUAL-3) Trial of Bofanglutide for Weight Management

Shots: Gan & Lee Pharmaceuticals has initiated a P-III (GRADUAL-3) study of bofanglutide (GZR18) in adults with obesity or overweight The trial will assess the safety & efficacy of bofanglutide (SC, Q4W) in obese or overweight pts for 24wks., while evaluating the change and the percentage change from baseline in body weight at 24wk. as…

November 28, 2025

Innovent Biologics Reports the Chinese NMPA Approval of Pecondle (Picankibart) to Treat Plaque Psoriasis

Shots: The Chinese NMPA has approved Pecondle (picankibart) for the treatment of mod. to sev. plaque psoriasis (PsO) in adults who are candidates for systematic therapy Approval was supported by the P-III (CLEAR-1) trial in Chinese pts with mod. to sev. PsO, where picankibart demonstrated significantly higher PASI 90 (1EP; 80.3% vs 2%) & sPGA 0/1…

November 28, 2025

Innocare Doses First Patient in P-II Trial of Soficitinib for Prurigo Nodularis in China

Shots: Innocare has dosed the first patient in the global P-II trial of Soficitinib (ICP-332) for the treatment of pts with prurigo nodularis in China Soficitinib was also evaluated in the P-II trial for mod. to sev. atopic dermatitis, which showed superior efficacy & favorable safety, with data presented at the AAD’25 Soficitinib, a selective…

November 28, 2025

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

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

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

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

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

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

NEWS

Imugene Collaborates with JW Therapeutics to Advance onCARlytics and Carteyva Combination in Solid Tumours

Gan & Lee Pharmaceuticals Initiates P-III (GRADUAL-3) Trial of Bofanglutide for Weight Management

Innovent Biologics Reports the Chinese NMPA Approval of Pecondle (Picankibart) to Treat Plaque Psoriasis

Innocare Doses First Patient in P-II Trial of Soficitinib for Prurigo Nodularis in China

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

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

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

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

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

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

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