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Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)
Shots: The CHMP has recommended Astellas' Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC; If approved, authorization would be valid in all 30 EEA states Opinion was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or…
May 22, 2026
Tempus AI Launches ArteraAI Prostate Test for Metastatic Prostate Cancer
Shots: Tempus AI has reported clinical launch of the ArteraAI Prostate Test (mHSPC), a CLIA-certified & CAP-accredited prognostic assay designed for pts with metastatic hormone-sensitive prostate cancer (mHSPC) ArteraAI Prostate Test (mHSPC) is an externally developed digital pathology algorithm clinically available through the Tempus AI ecosystem, with full platform integration to support personalized treatment decisions…
May 22, 2026
Polpharma Partners with Tuteur to Commercialize a Biosimilar Candidate Across LATAM for Autoimmune Diseases
Shots: Polpharma Biologics has entered into a licensing agreement with Tuteur to commercialize a biosimilar candidate for autoimmune diseases across Latin America, excl. Brazil As per the deal, Tuteur will handle commercialization, marketing, & distribution in the licensed territories, while Polpharma will be responsible for the development & manufacturing of the biosimilar candidate The biosimilar…
May 22, 2026
Merck
Merck Reports the P-III (TroFuse-005) Trial Data on Sacituzumab Tirumotecan for Advanced or Recurrent Endometrial Cancer
Shots: Merck has reported global P-III (TroFuse-005) trial data assessing sac-TMT (4 mg/kg, Q2W) vs doxorubicin/paclitaxel in 776 pts with endometrial carcinoma & carcinosarcoma who have received prior Pt-based CT & anti-PD-1/anti-PD-L1 immunotherapy either together or separately Trial met its 1EP of improved OS & PFS in the above pts, plus it also reached its key…
May 22, 2026
Medtronic Plans to Acquire SPR Therapeutics, Strengthening its Pain Portfolio
Shots: Medtronic has announced its intent to acquire SPR Therapeutics for an upfront payment of ~$650M, aiming to expand its neuromodulation portfolio with temporary peripheral nerve stimulation (PNS) tech for chronic pain management Acquisition will add SPR’s FDA-cleared SPRINT PNS System to Medtronic’s pain management portfolio, which showed over 71% pts experienced significant pain relief…
May 21, 2026
Reflow Medical
Reflow Medical Reports DEEPER CORONARY Study Results on Spur Elute Stent System for Coronary In-Stent Restenosis (ISR)
Shots: Reflow Medical has reported the DEEPER CORONARY study results evaluating the short-term safety of the coronary Spur Elute Sirolimus-Eluting Retrievable Stent System for coronary ISR at EuroPCR 2026 6mos. results showed 100% freedom from MACE & all-cause mortality in nine treated pts, while all patients demonstrated improved CCS angina class with a median improvement of…
May 21, 2026
Eli Lilly Acquires Engage Biologics for ~$202M
Shots: Eli Lilly has acquired Engage Biologics, combining Engage’s Tethosome platform with Lilly’s genetic medicines capabilities & portfolio As per the deal, Eli Lilly acquired Engage for ~$202M in cash, incl. an upfront payment and subsequent development milestones payments The Tethosome platform is a non-viral DNA delivery system that combines engineered DNA payloads, lipid nanoparticles,…
May 21, 2026
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