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Jazz Pharmaceuticals Enters a ~$1.03B Licensing Deal with Saniona for SAN2355
Shots: Jazz Pharmaceuticals has entered into a global license agreement with Saniona to develop SAN2355 for epilepsy & other potential indications As per the deal, Jazz will lead & fund development, regulatory filings, & global commercialization in exchange for $42.5M upfront, ~$192.5M in development & regulatory milestones (incl. $7.5M at P-I initiation), ~$800M in commercial milestones, &…
Novo-Nordisk
Novo Nordisk Reports the Health Canada’s Approval of Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in T2D & CKD Adults
Shots: Health Canada has approved Ozempic to reduce the risk of kidney disease worsening & CV death in adults with type 2 diabetes (T2D) & chronic kidney disease (CKD) Approval was based on P-IIIb (FLOW) trial assessing Ozempic (1mg, Q1W, n=1767) vs PBO (n=1766) in type 2 diabetes & CKD pts (N=3533) Study met its 1EP of 24% relative…
Akesobio
Akeso Reports First Patient Dosing in P-III (COMPASSION-33) Trial of Cadonilimab for G/GEJ Adenocarcinoma
Shots: Akeso has enrolled & dosed its first patient with cadonilimab (PD-1/CTLA-4 BsAb) + CT in P-III (AK104-310/COMPASSION-33) trial for the perioperative treatment of resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma The P-III (COMPASSION-33) trial in resectable G/GEJ adenocarcinoma pts is designed to improve radical resection rates, lower recurrence & metastasis risk, & improve patient outcomes Additionally,…
VantAI Collaborates with Halda Therapeutics to Discover RIPTAC Medicines
Shots: VantAI has entered into a strategic research collaboration with Halda Therapeutics to advance the discovery & development of selective proximity-based therapies for cancer & immunology indications As per the deal, VantAI will receive over ~$1B incl. upfront, research support, development & commercial milestones as well as net sales-based tiered royalties VantAI will use its…
Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) Receives the EC’s Conditional Approval for MASH with Liver Fibrosis
Shots: The EC has granted conditional approval to Rezdiffra to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with mod. to adv. liver fibrosis in 30 EEA states; launch is planned throughout EU starting with Germany in Q4’25 Approval was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which…
RemeGen Enters a Licensing Agreement with Santen Pharmaceutical for RC28-E to Treat Eye Diseases
Shots: RemeGen has granted Santen exclusive rights to develop, manufacture, & commercialize RC28-E in Greater China (incl. Mainland China, Hong Kong, Macau, & Taiwan), South Korea, Thailand, Vietnam, Singapore, Philippines, Indonesia, & Malaysia, while RemeGen will retain its rights in other territories As per the deal, RemeGen will receive $38.9M (¥250M) upfront, ~$72.3M (¥520M) in…