NEWS

Vor Bio Enters a ~$4.12B Exclusive Global License Agreement with RemeGen to Develop and Commercialize Telitacicept

Shots: Vor Bio and RemeGen have entered an exclusive licensing agreement, giving Vor Bio rights outside China, Hong Kong, Macau, and Taiwan to develop & commercialize telitacicept As per the Deal, RemeGen will receive $125M ($45M upfront and $80M in stock warrants). RemeGen is eligible for more than $4B in regulatory & commercial milestones + tiered…

June 27, 2025

BeOne Receives CHMP Positive Opinion for New Brukinsa Tablet Formulation Across All Approved Indications

Shots: Following the US FDA approval, EMA's CHMP issued a positive opinion of Brukinsa (zanubrutinib) film‑coated tablets for all approved indications. EC will now review the opinion for MAA in the EU, Norway, and Iceland BRUKINSA tablets (160mg) are bioequivalent to the capsule form, supported by a P-I study. With a recommended daily dose of 320mg,…

June 27, 2025

Biocon Biologics Reports the Health Canada’s NOC for Yesafili (Biosimilar, Eylea)

Shots: Health Canada has granted NOC for Yesafili (vial & PFS presentations, 2 mg/0.05 mL), a biosimilar to Eylea (aflibercept), anticipated launch on Jul 04, 2025 Approval was supported by the P-III (INSIGHT) study in Diabetic Macular Edema(DME), which showed no clinically meaningful differences from EYLEA in PK, safety, efficacy, or immunogenicity. YESAFILI is a…

June 27, 2025

Vetigenics Doses First Patient in CHECKMATE K9 Study Evaluating VGS 001 + VGS 002 in Dogs with Solid Tumors

Shots: Vetigenics initiated dosing in a multisite CHECKMATE K9 pilot study evaluating the safety and preliminary efficacy of VGS 001 (anti‑cCTLA‑4 mAb) + VGS 002 (anti‑cPD‑1 mAb) in dogs with various solid tumors Early data from single-agent use demonstrated strong safety and encouraging therapeutic responses in Dogs VGS 001 is an anti‑cCTLA‑4 mAb and VGS…

June 27, 2025

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Shots: Kashiv BioSciences has reported topline results of ADL-018, its proposed biosimilar to Xolair (omalizumab) for Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) unresponsive to H1 antihistamines. The BLA and MAA filings for the product are expected with the FDA and EMA, respectively, in Q4’25 The study met its 1EPs & 2EPs, demonstrating therapeutic equivalence and…

June 27, 2025

Pfizer Reports the P-III (BASIS) Study Data Evaluating HYMPAVZI to Treat Hemophilia A or B with Inhibitors

Shots: Pfizer reported positive topline results from the P‑III (BASIS) study evaluating HYMPAVZI (marstacimab) in hemophilia A or B pts (N=48) with inhibitors, meeting the 1EP and demonstrating a 93% reduction in annualized bleeding rate (ABR) vs. on‑demand treatment (1.39 vs. 19.78; p < 0.0001) over 12mos. HYMPAVZI, a once‑weekly SC therapy that targets TFPI,…

June 27, 2025

Galderma Initiates P-II Studies of Nemolizumab for Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO)

Shots: Galderma announced the initiation of two P‑II clinical studies evaluating the efficacy and safety of nemolizumab in pts with SSc and CPUO Patient enrollment for both studies is planned to start in H2’25, with expected completion in 2028 for SSc and in 2026 (US) for CPUO Nemolizumab is a mAb targeting the IL‑31 receptor…

June 26, 2025

Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

Shots: The US FDA has approved Datroway (datopotamab deruxtecan-dlnk; 6 mg/kg) for adults with locally advanced or metastatic EGFR-mutated NSCLC previously treated with EGFR therapy & Pt CT Approval was based on the global P-II (TROPION-Lung05) trial results (n=137) and supported by data from the P-III (TROPION-Lung01) trial (n=590), which showed a 45% confirmed ORR…

June 26, 2025

Bio-Thera Solutions and SteinCares Broaden Collaboration to Commercialize (Biosimilar, Dupilumab) in Latin America

Shots: Bio-Thera Solutions & SteinCares signed an agreement to commercialize a proposed dupilumab biosimilar for inflammatory diseases in Latin America As per the deal, Bio-Thera will handle product development and supply, while SteinCares manages registration and commercialization in Latin America Dupilumab (SC) is a fully human mAb that blocks IL-4 and IL-13 signalling pathways and…

June 26, 2025

Bio-Thera Solutions Reports First Patient Dosing in P-III Study Evaluating BAT8006 for Pt Resistant Ovarian Cancer

Shots: Bio‑Thera reported the dosing of the first patient in a P‑III study assessing the efficacy of BAT8006 vs. the investigator’s choice of single-agent CT in individuals with Pt resistant high‑grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer Early clinical Data (N=133; irrespective of FRα expression or treatment history) presented at ASCO’25, from…

June 26, 2025

NEWS

Vor Bio Enters a ~$4.12B Exclusive Global License Agreement with RemeGen to Develop and Commercialize Telitacicept

BeOne Receives CHMP Positive Opinion for New Brukinsa Tablet Formulation Across All Approved Indications

Biocon Biologics Reports the Health Canada’s NOC for Yesafili (Biosimilar, Eylea)

Vetigenics Doses First Patient in CHECKMATE K9 Study Evaluating VGS 001 + VGS 002 in Dogs with Solid Tumors

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Pfizer Reports the P-III (BASIS) Study Data Evaluating HYMPAVZI to Treat Hemophilia A or B with Inhibitors

Galderma Initiates P-II Studies of Nemolizumab for Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO)

Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

Bio-Thera Solutions and SteinCares Broaden Collaboration to Commercialize (Biosimilar, Dupilumab) in Latin America

Bio-Thera Solutions Reports First Patient Dosing in P-III Study Evaluating BAT8006 for Pt Resistant Ovarian Cancer

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