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Nabla Bio Collaborates with Takeda to Advance AI-Driven Protein Therapeutics Design
Shots: Nabla Bio has entered into a multi-year research collaboration with Takeda to advance AI-driven design of protein therapeutics, leveraging Nabla Bio’s Joint Atomic Model (JAM) Nabla Bio will deploy its proprietary JAM platform across Takeda’s early-stage programs to enable de novo antibody design for multiple targets, multi-specifics, challenging targets, & custom therapeutics As per the…
SystImmune Doses First Patient in P-II/III (IZABRIGHT-Breast01) Trial of Iza-Bren to Treat Triple Negative Breast Cancer (TNBC)
Shots: SystImmune has dosed the first patient with izalontamab brengitecan (iza-bren) in the global P-II/III (IZABRIGHT-Breast01) study for previously untreated TNBC ineligible for anti-PD-(L)1 drugs First patient dosing triggered $250M milestone payment to SystImmune under its 2023 deal with BMS, where SystImmune is further eligible to receive additional ~$250M in contingent near-term payments & ~$7.1B…
China’s NMPA Approves GSK’s Shingrix to Protect Individuals Against Shingles
Shots: China’s NMPA has approved Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster) in adults (≥18yrs.) at increased risk due to immunodeficiency or immunosuppression caused by known disease or therapy Approval was supported by 6 trials in pts (≥18yrs.) who had undergone recent stem cell transplantation, kidney transplant, or had blood cancer, solid…
Roche
Roche’s Elecsys pTau181 Test Receives the US FDA’s Clearance to Rule Out Alzheimer’s Disease
Shots: The US FDA has cleared the Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.) Elecsys pTau181 was evaluated in a non-interventional study of 312 participants, showing 97.9% negative predictive value (NPV) in an early disease-stage, low-prevalence population Elecsys pTau217 is an in-vitro diagnostic…
NEXTBIOMEDICAL Enrolls First Patient in RESORB Trial of Nexsphere-F to Use it in Genicular Artery Embolization (GAE) for Knee Osteoarthritis
Shots: NEXTBIOMEDICAL has enrolled the first patient in the RESORB trial, evaluating Nexsphere-F vs intra-articular corticosteroid injections for use in GAE in ~126 US pts with painful knee osteoarthritis Nexsphere-F data from 155 pts published in The JVIR showed a 67% average pain reduction at 6mos., while a study published in The OJSM demonstrated safety…
Surgical Theater’s SyncAR Spine Platform Secures the US FDA’s 510(k) Clearance for Spine Surgery
Shots: The US FDA has granted 510(k) clearance to SyncAR Spine platform to enhance precision in spine surgery SyncAR Spine, integrated with Medtronic StealthStation, uses AI-driven vertebra segmentation, advanced decompression planning, & segmental fusion to streamline surgical planning & help align preoperative models with intraoperative CT SyncAR Spine also allows surgeons to monitor bone removal…