Skip to content Skip to footer
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)…

Read more

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),…

Read more

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…

Read more

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…

Read more

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…

Read more

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…

Read more