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Summit Therapeutics Initiates P-II/III (HARMONi-GU1) Trial of Ivonescimab + Enfortumab Vedotin in Bladder Cancer
Shots: Summit has initiated P-II/III (HARMONi-GU1) trial of ivonescimab + enfortumab vedotin (EV) against Keytruda + EV as first-line treatment of locally advanced or metastatic urothelial (bladder) cancer The global, multi-regional trial will enroll ~800 pts through P-III, with site activations beginning later this year. P-II will determine the recommended P-III dose of ivonescimab in…
2 days ago
Natera Seeks PMDA Approval for Signatera CDx in MIBC
Shots: Natera has submitted an application to Japan's PMDA seeking approval of Signatera as a companion diagnostic (CDx) for muscle-invasive bladder cancer (MIBC) The submission expands the company's presence in Japan, where Signatera became the country's first PMDA-approved molecular residual disease (MRD) test for colorectal cancer in Jun 2026 Application is supported by data from…
2 days ago
SOPHiA GENETICS and AstraZeneca Partner to Develop Companion Diagnostics for Precision Oncology
Shots: SOPHiA GENETICS has entered a global collaboration with AstraZeneca to develop, validate, & commercialize two companion diagnostics (CDx) supporting precision oncology therapies The multi-year collaboration will leverage SOPHiA’s decentralized clinical trial assays & CDx capabilities to advance development & commercialization of the CDx programs As per the deal, SOPHiA GENETICS will develop its Solid Tumor…
2 days ago
Sight Sciences’ OMNI Ultra Surgical System Secures the US FDA 510(k) Clearance
Shots: The US FDA has granted 510(k) clearance to the OMNI Ultra Surgical System for canaloplasty followed by trabeculotomy for the reduction of intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG) The OMNI platform is backed by extensive clinical evidence showing sustained IOP reduction and reduced medication use, with the OMNI Ultra remaining on…
2 days ago
KKR to Acquire Integer for ~$5.7B
Shots: Integer and KKR have entered into a definitive agreement under which an affiliate of investment funds managed by KKR will acquire Integer, delisting it from NYSE As per the deal, KKR will acquire Integer in an all-cash transaction valued at $127 per share, representing the total enterprise value of ~$5.7B As a KKR portfolio…
2 days ago
Galaxy Therapeutics Secures CE Mark for SEAL Embolization System
Shots: Galaxy has received CE Mark under the EU MDR 2017/745 for its SEAL Embolization System, following assessment by Notified Body DQS Medizinprodukte. Launch expected across selected EU markets, with FDA’s PMA application underway The SEAL Embolization System is an intrasaccular device for endovascular treatment of ruptured & unruptured wide-neck intracranial aneurysms, supporting aneurysm sizes…
3 days ago
Nurix Therapeutics Enrolled First Patient in P-III (DAYBreak CLL-306) Trial of Bexobrutideg in R/R CLL/SLL
Shots: Nurix has enrolled the first patient in the global P-III (DAYBreak CLL-306) study assessing bexobrutideg in pts with r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received a covalent BTK inhibitor The trial, conducted under the collaboration between Nurix and Roche, is expected to enroll ~620 pts, where they will be randomized…
3 days ago
Sanofi
Sanofi Reports the EC Approval of MenQuadfi for Use in Infants from Age 6 Weeks Against Invasive Meningococcal Disease
Shots: The EC has approved an extension of the indication of MenQuadfi to incl. infants (≥6wks.) for protection against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, & Y Approval was supported by extensive data from the MET58 clinical study, which evaluated the immunogenicity, safety, & tolerability of MenQuadfi in infants from 6wks. of…
3 days ago
Biocon Launches Yesafili (Biosimilar, Eylea) in the US
Shots: Biocon has reported the commercial launch of Yesafili, a biosimilar version of Eylea 2mg (aflibercept), in the US, which was previously approved & granted interchangeable designation In the P-III (INSIGHT) study in Diabetic Macular Edema (DME), Yesafili showed no clinically meaningful differences from Eylea in PK, safety, efficacy, or immunogenicity Yesafili is a VEGF inhibitor…
3 days ago
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