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PharmaEssentia Reports the US FDA’s sBLA Acceptance of Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia
Shots: The US FDA has accepted sBLA of ropeginterferon alfa-2b-njft for the treatment of adults with essential thrombocythemia, with a PDUFA target action date of Aug 30, 2026 sBLA is supported by the statistically significant and clinically meaningful data from the P-III (SURPASS-ET) trial as well as North American P-IIb (EXCEED-ET) trial  Ropeginterferon alfa-2b-njft received…
January 14, 2026
Zonsen PepLib Biotech Grants Novartis Global License for Radioligand Therapy Asset with $50M Upfront
Shots: Zonsen PepLib Biotech has entered into a worldwide license agreement with Novartis for an undisclosed peptide-based radioligand therapy asset As per the deal, Novartis will obtain exclusive worldwide rights & lead the development & commercialization activities for the undisclosed asset In return, PepLib will receive $50M upfront, with additional development, regulatory, & sales milestone payments,…
January 14, 2026
Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin) 
 Shots:  The US FDA has accepted the BLA for HLX04, a biosimilar version of Avastin (bevacizumab)  BLA was supported by analytical similarity studies, a P-I PK comparability trial in healthy subjects, and a multicenter P-III trial in pts with metastatic colorectal cancer, evaluating HLX04 vs the reference product for safety, PK, and immunogenicity  Henlius is advancing a P-II/III trial of HLX04 + serplulimab for 1L…
January 13, 2026
BMS
BMS Reports P-III (SCOUT-HCM) Trial Findings on Camzyos for Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Shots: BMS reported topline P-III (SCOUT-HCM) trial data evaluating Camzyos (mavacamten) in 44 adolescents (12 to <18yrs.) with symptomatic oHCM, comprising a 28wk. PBO-controlled phase, an ongoing 28wk. active-treatment phase, & a 144wk. open-label LTE Trial met its 1EP, showing reduced Valsalva LVOT gradient at Wk. 28, & achieved statistical significance across multiple 2EPs, incl.…
January 13, 2026
SciNeuro Forges ~$1.7B Deal with Novartis to Advance Therapeutics for Alzheimer’s Disease
Shots: SciNeuro has entered into a global licensing & collaboration deal with Novartis to advance its amyloid beta-targeted antibody program for Alzheimer’s disease The program has identified de novo antibody candidates using SciNeuro’s blood–brain barrier shuttle tech, with Novartis leading global development & commercialization after collaboration on early development As per the deal, SciNeuro will…
January 13, 2026
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