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Merck
Merck Reveals P-III (CORALreef HeFH) Trial Data on Enlicitide Decanoate for Heterozygous Familial Hypercholesterolemia (HeFH)
Shots: Merck has highlighted P-III (CORALreef HeFH) trial data assessing enlicitide decanoate (20mg, PO, QD) vs PBO in 303 adults with HeFH at AHA’25 Trial showed significant LDL-C reductions (1EP), along with decreases in non-HDL-C (53%), ApoB (49.1%), & Lp(a) (27.5%) at Wk. 24 in HeFH pts on stable background lipid-lowering therapy. High adherence (97%) &…
SanegeneBio Collaborates with Eli Lilly to Advance RNAi Therapeutics for Metabolic Diseases
Shots: SanegeneBio has entered into a global research & licensing deal with Eli Lilly to advance RNAi candidates for metabolic diseases, leveraging SanegeneBio’s LEAD (Ligand & Enhancer Assisted Delivery) tech Under the deal, SanegeneBio will discover & identify LEAD-based RNAi molecules for each program, while Lilly will oversee IND-enabling studies, clinical development, & commercialization; the…
Metsera Announces an Amended Merger Agreement with Pfizer for ~$10B
Shots: Metsera announced entering into an amended merger agreement with Pfizer to acquire Metsera for up to $86.25 per share, including $65.60 in cash and a contingent value right of up to $20.65 Metsera’s Board of Directors noted that the U.S. Federal Trade Commission had raised potential antitrust concerns regarding Novo Nordisk’s proposed structure  After…
Nitinotes Reports the European CE Mark Approval of EndoZip for Endoscopic Sleeve Gastroplasty
Shots: Nitinotes has received CE Mark approval for its EndoZip System for endoscopic sleeve gastroplasty (ESG) EndoZip automates suturing, transforming ESG into a single-physician, scalable, fast outpatient procedure with improved efficiency & reproducibility compared to manual systems requiring dual operators & longer procedure times The company has planned to launch EndoZip in select EU centers &…
Alvotech & Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the MHRA’s Approval to Treat Several Chronic Inflammatory Diseases
Shots: The UK’s MHRA has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, axial spondylarthritis & ulcerative colitis in adult pts & juvenile idiopathic arthritis, following CHMP’s positive opinion Additionally, Alvotech is responsible for the development & commercial supply of Gobivaz, while…