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)…
The US FDA has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] for treating primary immunodeficiency (PI) pts (age≥2); commercialization will be anticipated in 2026 and in the EU in 2027, where it’s approved as DEQSIGA by the EMA
GAMMAGARD LIQUID ERC is a 10% ready-to-use IG therapy with ≤2 µg/mL IgA, for IV or…
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),…
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…
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…
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…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, and Animal Health. Check out our full report below:
Teva Reports the Data from the P-IV (PEARL) Study of Ajovy (fremanezumab) for Chronic and Episodic Migraine Prevention
Read More: Teva
Merck Reports the Data from P-III (HYPERION)…
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…

