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Rhythm Pharmaceuticals
NEWS
Rhythm Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Setmelanotide to Treat Acquired Hypothalamic Obesity
Shots: The US FDA has accepted sNDA of setmelanotide for the treatment of conditions associated with acquired hypothalamic obesity (PDUFA: Dec 20, 2025); Type II variation MAA is under the CHMP’s review sNDA & MAA were supported by global P-III (TRANSCEND) trial (N=120) assessing setmelanotide (n=81) vs PBO (n= 39) in 49 adults & 71 pediatric…
August 21, 20250Comments
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, 20250Comments
Roadblocks to Specialty Medicines Access: Colin Banas from DrFirst in Conversation with PharmaShots
VIEWPOINTS
Roadblocks to Specialty Medicines Access: Colin Banas from DrFirst in Conversation with PharmaShots 
Shots:  Fragmented workflows continue to be a major roadblock in the healthcare ecosystem, causing unnecessary delays in care delivery  Automated solutions help bridge the gaps resulting from disjointed workflows and expedite prior authorization, pharmacy routing, and patient onboarding  Colin Banas, CMO at DrFirst, joins PharmaShots in a discussion highlighting the company’s recent acquisition of Myndshft…
August 20, 20250Comments
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, 20250Comments
Akesobio
NEWS
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, 20250Comments
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, 20250Comments
Hutchmed
NEWS
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, 20250Comments
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, 20250Comments