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NEWS

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, &…
August 21, 2025

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Novo-Nordisk
NEWS

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…
August 20, 2025

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Akesobio
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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,…
August 20, 2025

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NEWS

Health Canada Grants Conditional Approval to Iovance’s Amtagvi (Lifileucel) for Advanced Melanoma

Shots: Health Canada has granted conditional approval (NOC/c) to Amtagvi for adults with unresectable or metastatic melanoma progressing after prior systemic therapy, incl. PD-1 inhibitor &, if BRAF V600 positive, then BRAF ± MEK inhibitor, with no suitable alternative options Approval was granted based on global P-II (C-144-01) trial assessing Amtagvi in above pts, which…
August 20, 2025

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Hutchmed
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HUTCHMED Completes Patient Enrolment in P-III (SANOVO) Trial of Orpathys (savolitinib) and Tagrisso (osimertinib) for EGFRm NSCLC

Shots: HUTCHMED has completed enrolment in its P-III (SANOVO) trial to assess Orpathys + Tagrisso as a 1L treatment of pts with locally advanced or metastatic NSCLC harboring EGFR mutation & MET overexpression; last patient was enrolled in Aug 18, 2025 Trial will evaluate Orpathys + Tagrisso vs Tagrisso in NSCLC pts, assessing PFS as 1EP,…
August 20, 2025

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NEWS

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…
August 20, 2025

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NEWS

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…
August 20, 2025

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NEWS

ONWARD Medical Receives FDA IDE Approval for ARC-IM System to Treat Blood pressure Instability in Spinal Cord Injury

Shots: ONWARD Medical has received the US FDA IDE approval to initiate its Empower BP study evaluating ARC-IM System for blood pressure instability in spinal cord injury The IDE trial will assess ARC-IM System in pts with C2–T6 spinal cord injuries, injury severities of AIS A-D & blood pressure instability, incl. chronic OH & autonomic…
August 19, 2025

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NEWS

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…
August 19, 2025

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