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Merck Reports Topline P-III (CORALreef Lipids) Trial Data of Enlicitide Decanoate to Treat Hypercholesterolemia
Shots: Merck has reported topline P-III (CORALreef Lipids) trial data assessing enlicitide decanoate vs PBO for the treatment of adults with hypercholesterolemia receiving mod. to high-intensity statins or are intolerant to statins Trial met its 1EP with significant LDL-C reduction at Wk. 24 & achieved 2EPs, showing reduced non-HDL-C, apolipoprotein B, & lipoprotein(a) levels; data…
September 3, 2025
Novatim Immune Therapeutics (Keyi Pharmaceutical) Inks a ~$1.16B Licensing Deal with RADIANCE Biopharma for KY-0301 to Treat Cancer
Shots: Novatim has entered into an exclusive global licensing agreement (excl. China) with RADIANCE Biopharma for KY-0301 to treat cancer  As per the deal, RADIANCE Biopharma will receive rights to develop, register, & commercialize KY-0301 globally (excl. China) in exchange for $15M upfront, ~$150M in R&D & registration milestones & ~$1B in commercial milestone, with progressive…
September 3, 2025
Enlaza Therapeutics Collaborates with Vertex to Develop Drug Conjugates and T-Cell Engagers for Improved Conditioning and Autoimmune Diseases
Shots: Enlaza & Vertex’s muti-target collaboration will leverage Enlaza’s War-Lock platform to develop small format drug conjugates & T-cell engagers for autoimmune diseases & improved conditioning in sickle cell disease & β thalassemia Enlaza will receive $45M in upfront & equity investment & is eligible for >$2B in research, development, regulatory, & commercial milestones plus…
September 3, 2025
Arrowhead Enters a ~$2.2B Deal with Novartis for ARO-SNCA and TRiM-Based Therapies to Treat Neurodegenerative Diseases
Shots: Arrowhead has granted Novartis exclusive global rights to develop, manufacture, & commercialize ARO-SNCA, which leverages the TRiM platform for SC dosing & targeted gene delivery to treat synucleinopathies, incl. Parkinson’s disease As per the deal, Arrowhead will receive $200M upfront & ~$2B in development, regulatory, and sales milestones, with tiered royalties on sales up…
September 3, 2025
Henlius & Organon
Henlius and Organon Receive the US FDA’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)
Shots: The US FDA has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable quality, efficacy & safety of Bildyos & Bilprevda to reference denosumab In 2022,…
September 3, 2025
IDEAYA Biosciences Partners with Servier to Develop and Commercialize Darovasertib for Uveal Melanoma (UM)
Shots: IDEAYA has entered an exclusive licensing agreement granting Servier global regulatory and commercial rights to darovasertib, while retaining all the US rights IDEAYA & Servier will co-develop darovasertib & share costs, with Servier leading regulatory & commercial efforts worldwide excl. the US, in exchange for $210M upfront, ~$100M on approval, ~$220M in commercial milestones,…
September 2, 2025
Polpharma Biologics Enters into Licensing Deals with MS Pharma for Multiple Biosimilar Candidates
Shots: Polpharma has entered into licensing deals with MS Pharma to commercialize PB016 (vedolizumab), PB018 (ocrelizumab), & PB019 (guselkumab) biosimilars across the Middle East & North Africa (MENA) region As per the deal, MS Pharma will be responsible for registration, marketing, & distribution of the 3 biosimilars in MENA, while Polpharma will handle development, manufacturing,…
September 2, 2025
OMass Therapeutics Collaborates with Genentech to Develop and Commercialize Small Molecule for Inflammatory Bowel Disease
OMass has entered into an exclusive collaboration & license deal with Genentech to develop & commercialize its preclinical oral small molecule program for inflammatory bowel disease As per the deal, OMass will receive $20M upfront & over $400M in preclinical, development, commercial, & sales milestones, with tiered royalties based on net sales Collaboration leverages OMass’…
September 2, 2025
Novartis
Novartis Reports P-IV (V-DIFFERENCE) Trial Findings on Leqvio (Inclisiran) for Hypercholesterolemia
Shots: Novartis has reported P-IV (V-DIFFERENCE) trial results evaluating Leqvio (n=898) vs PBO (n=872), both added to personalized lipid-lowering therapy (LLT), in 1,770 hypercholesterolemia pts not at guideline-recommended LDL-C goals Trial showed 85% vs 31% achieved their guideline-recommended LDL-C target after 90 days of treatment, with benefits seen as early as day 30 (81% on…
September 2, 2025
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