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Merck & Hengrui
NEWS

Merck Partners with Jiangsu Hengrui Pharmaceuticals for HRS-5346, Expanding its Cardio-Metabolic Portfolio

Shots: Merck has entered into an exclusive license agreement with Jiangsu Hengrui Pharmaceuticals for HRS-5346 As per the deal, Merck has obtained exclusive rights to develop, manufacture & commercialize HRS-5346 globally excl. Greater China region in exchange for $200M upfront & ~$1.77B in development, regulatory & commercial milestones, along with net sales-based royalties; closing expected…
March 25, 2025

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Alumis & Kaken
NEWS

Alumis and Kaken Pharmaceutical Enter Collaboration & Licencing Deal for ESK-001’s Development & Commercialization in Japan

Shots: Alumis & Kaken have partnered to develop, manufacture, & market ESK-001 for dermatology in Japan, with an option to expand into rheumatology & GI diseases As per the deal, Kaken will handle development, approval & marketing of ESK-001 in Japan in exchange for $40M upfront & near-term co-development costs, with ~$140M in milestones & field…
March 25, 2025

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Sanofi
NEWS

Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis

Shots: The US FDA has accepted NDA & granted priority review to tolebrutinib for nrSPMS & slowing disability progression independent of relapse (PDUFA: Sep 28, 2025); MAA is under EMA review Submission was backed by P-III trials, incl. HERCULES for nrSPMS & GEMINI 1 & 2 for relapsing MS, along with clinical & preclinical data…
March 25, 2025

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Avatar Medical & FX Shoulder Solutions
NEWS

Avatar Medical & FX Shoulder Solutions Reports the US FDA’s 510(k) Clearance of brAIn Shoulder Positioning System (SPS) for Arthroscopic Surgeries

Shots: The US FDA has granted 510(k) clearance to brAIn SPS for preoperative planning & implant placement in shoulder surgery brAIn SPS, developed via FX & Avatar, combines AI-driven imaging, with 3D avatar visualization for precise soft tissue assessment to optimize implant positioning & joint function while enhancing accuracy & recovery in comparison to conventional…
March 25, 2025

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New Drug Designations - February 2025
INSIGHTS+

New Drug Designations – February 2025

Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA   The February 2025 report covers designations granted to 53 drugs and 4 medical devices, spanning 16 small molecules, 14 biologics, 18 cell and gene therapies & 4 medical devices among…
March 25, 2025

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Endo & Mallinckrodt
NEWS

Endo & Mallinckrodt Pharmaceuticals to Form a Combine Entity with $6.7B Cash-and-Stock

Shots: Mallinckrodt & Endo to combine their generic pharmaceuticals & Endo’s sterile injectables businesses, later separating the unit, with combined company headquartered in Dublin, Ireland & Endo operating as Mallinckrodt’s subsidiary As per the deal, Endo shareholders will receive $80M in cash & own 49.9% of the combined company, while Mallinckrodt shareholders will hold 50.1%,…
March 18, 2025

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Incyte
NEWS

Incyte Reports Topline Data from P-III (STOP-HS1 & STOP-HS2) Trials of Povorcitinib (INCB054707) for Hidradenitis Suppurativa (HS)

Shots: The 2 P-III (STOP-HS1 & STOP-HS2) trials assessed povorcitinib (45 or 75mg, QD, PO) vs PBO in mod. to sev. HS pts (≥18yrs.; n=600 each) for 12wks., followed by 42wk. extension & 30-day follow-up STOP-HS1 met its 1EP, with povorcitinib (45 mg/75 mg) showing higher HiSCR50 rates at Wk. 12 (40.2%/40.6% vs 29.7%), while…
March 18, 2025

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