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Fresenius Kabi
Fresenius Kabi Launches Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) in the US 
Shots:  Fresenius Kabi launched Conexxence and Bomyntra, biosimilar of Prolia & Xgeva (denosumab) for all indications of the reference products across the US  Conexxence (denosumab-bnht) 60 mg/mL, available in PFS, is approved for adults at high risk of fractures, including those with osteoporosis, pts. on cancer treatments affecting bone density, or long-term glucocorticoids   Bomyntra (denosumab-bnht)…
July 1, 2025
Amgen
Amgen Reports Data from the P-III (FORTITUDE-101) Study Evaluating Bemarituzumab in FGFR2b+ 1L Gastric Cancer
Amgen’s P-III (FORTITUDE-101) study (n=547) met its 1EP at interim analysis, showing statistically significant OS improvement with bemarituzumab + CT (mFOLFOX6) vs PBO + CT in FGFR2b+ unresectable locally advanced/metastatic G/GEJ cancer (FGFR2b ≥10% IHC 2+/3+) P-III (FORTITUDE-101) study 2EPs include PFS and ORR; the safety profile of bemarituzumab + CT was consistent with prior…
July 1, 2025
Neurocrine Biosciences Initiates P-I Study of NBIP-01435 to Treat CAH
Neurocrine initiated a P-I first-in-human study of NBIP-01435 to assess safety, PK/PD, tolerability, and immunogenicity in healthy adults via SC injection for the potential treatment of congenital adrenal hyperplasia (CAH) NBIP-01435 (CRF1 antagonist) aims to improve androgen control and reduce glucocorticoid dosing. In Dec’24, the FDA approved Neurocrine's crinecerfont, an oral CRF1 antagonist, to treat…
July 1, 2025
Omeros Submits MAA to the EMA for Narsoplimab (OMS721) to Treat TA-TMA
S Shots: Omeros submitted an MAA to the EMA for narsoplimab to treat TA-TMA, with data demonstrating a 61% response rate and a 3x improvement in OS vs matched external controls; over 130 pts treated under expanded access data were also included EMA granted Narsoplimab ODD status, and CHMP review will start mid-July under centralized…
June 30, 2025
Sobi Reports the US FDA Approval of Gamifant for Macrophage Activation Syndrome in Still’s Disease
Shots: The US FDA has approved Gamifant (emapalumab-lzsg) for treating hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still's disease, including systemic Juvenile Idiopathic Arthritis (sJIA), in pts of all ages who are unresponsive, intolerant to glucocorticoids, or have recurrent MAS Approval was based on pooled data from two pivotal trials, P-III (EMERALD) and P-II (NI-0501-06),…
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
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
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