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Bunkerhill Health Receives the US FDA’s 510(k) Clearance for Bunkerhill MAC to Detect and Quantify Mitral Annular Calcification
Shots: The US FDA has granted 510(k) clearance to Bunkerhill MAC algorithm for the detection & quantification of mitral annular calcification (MAC) Bunkerhill MAC, developed & tested using data from 25+ academic centers incl. Emory, Thomas Jefferson, & UCSF, automatically identify & quantify MAC on routine non-gated chest CTs using AI to standardize MAC detection &…
October 9, 2025
Zenas BioPharma Enters ~$2B Deal with InnoCare Pharma for Three Autoimmune Product Candidates
Shots: InnoCare granted Zenas exclusive global rights to develop, manufacture, & commercialize orelabrutinib for MS & non-oncology indications (excl. Greater China & Southeast Asia), plus rights to an IL-17AA/AF inhibitor outside those regions & a brain-penetrant TYK2 inhibitor globally As per the deal, InnoCare will receive $100M in upfront & near-term milestones, incl. 2026 milestones,…
October 8, 2025
Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care
Shots: Vektor Medical has received the European CE Mark approval for vMap System for non-invasive arrhythmia mapping vMap System converts 12-lead ECG data into 3D arrhythmia source maps within a minute to help identify arrhythmia drivers & guide treatment for atrial fibrillation & ventricular tachycardia The system also integrates with lab workflows to deliver rapid, non-invasive,…
October 8, 2025
Hikma and Celltrion Partner to Commercialize Biosimilars Across the MENA Region
Shots: Hikma Pharmaceuticals & Celltrion have entered into exclusive licensing agreements for various biosimilar candidates across the Middle East & North Africa (MENA) region, expanding their previous partnerships The agreement will include the commercialization of 6 biosimilars to expand access across multiple therapeutic areas, incl. allergic diseases, ophthalmology, skeletal-related disorders, immune diseases & oncology As…
October 8, 2025
Sanofi
Sanofi Reports P-II (ALPHAMEDIX-02) Trial Data of AlphaMedix for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)
Shots: Sanofi has reported data from the ongoing P-II (ALPHAMEDIX-02) trial assessing AlphaMedix (67.6μCi/kg, Q8W, ~4 cycles) in pts, incl. PRRT-naïve (n=35) & exposed (n=26) pts with histologically confirmed unresectable or metastatic SSTR+ GEP-NETs & ≥1 site of measurable disease Trial met all 1EPs with improved ORR & prolonged benefit, plus showed improvement across 2EPs…
October 8, 2025
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