NEWS

UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients

Shots: UCB reported the P-III study (n=87; ages 1-35yrs.) of adjunctive fenfluramine vs. PBO in CDKL5 Deficiency Disorder (CDD) diagnosis and uncontrolled seizure pts. The P-III study met its 1EP (median % reduction in countable motor seizure frequency) and most key 2EPs. Fenfluramine was well tolerated with a consistent safety profile in prior DS/LGS studies UCB…

June 30, 2025

XtalPi and Pfizer Expand Partnership to Advance AI-Driven Drug Discovery and Materials Simulation

XtalPi has expanded its collaboration with Pfizer to develop an advanced AI-powered molecular modeling platform, aiming to improve the speed and accuracy of small-molecule drug discovery by combining physics-based methods with scalable AI tools Under the expansion, XtalPi and Pfizer will develop predictive models tailored to Pfizer’s chemical space, enhancing small-molecule drug discovery. XtalPi will…

June 30, 2025

Neurocrine Reports Data From KINECT-HD Study Evaluating INGREZZA in Huntington’s Disease (HD)

Neurocrine reported new post-hoc patient data from the P-III KINECT-HD study (n=128; 18-75yrs.) showing significant reductions in cognitive and motor-related burden with INGREZZA (valbenazine) vs. PBO in HD chorea At maintenance (10-12wks.), INGREZZA showed greater mean score reductions across 18 cognition items and 32 of 33 motor items vs PBO. The study used the UHDRS…

June 30, 2025

Mabwell Signs Licensing Agreement with Qilu Pharmaceutical for Albipagrastim Alfa Injection Technology

Mabwell's subsidiary T-mab has signed a licensing deal with Qilu Pharmaceutical for Albipagrastim alfa (R&D code: 8MW0511) across Greater China As per the deal, Mabwell will grant Qilu exclusive rights to develop, manufacture, improve, utilize, and commercialize Albipagrastim alfa in Greater China(including the Chinese Mainland, Hong Kong, Macau, and Taiwan). T-mab will receive up to…

June 30, 2025

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

NEWS

UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients

XtalPi and Pfizer Expand Partnership to Advance AI-Driven Drug Discovery and Materials Simulation

Neurocrine Reports Data From KINECT-HD Study Evaluating INGREZZA in Huntington’s Disease (HD)

Mabwell Signs Licensing Agreement with Qilu Pharmaceutical for Albipagrastim Alfa Injection Technology

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

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