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NEWS

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…
October 14, 2025

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Roche
NEWS

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…
October 14, 2025

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NEWS

MannKind Reports the US FDA’s sBLA Acceptance of Afrezza (Inhaled Insulin) for Children and Adolescents with Diabetes

Shots: The US FDA has accepted sBLA of Afrezza (insulin human) Inhalation Powder for the treatment of children & adolescents with type 1 or type 2 diabetes (PDUFA: May 29, 2026) sBLA was supported by P-III (INHALE-1), assessing Afrezza vs multiple daily injections (MDI), both in addition to basal insulin among type1/2 diabetic pts (4-17yrs.)…
October 14, 2025

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NEWS

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…
October 14, 2025

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NEWS

BeOne Medicines’ Sonrotoclax Receives FDA’s Breakthrough Therapy Designation for R/R Mantle Cell Lymphoma (MCL)

Shots: The US FDA has granted BTD to sonrotoclax for adults with r/r MCL & accepted BeOne’s request for participation in Project Orbis for concurrent global review of the therapy Decision was based on P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on…
October 13, 2025

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Hutchmed
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HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib + Sintilimab for Renal Cell Carcinoma (RCC)

Shots: HUTCHMED has reported the P-II/III (FRUSICA-2) trial data assessing fruquintinib + sintilimab vs axitinib/everolimus as 2L treatment in 234 pts with locally advanced or metastatic RCC  As of Feb 17, 2025 (mFU of 16.6mos.), regimen showed a mPFS of 22.2 vs 6.9mos., ORR of 60.5% vs 24.3%, & mDoR 23.7 vs 11.3mos., with benefits observed…
October 13, 2025

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NEWS

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…
October 13, 2025

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Arcus Biosciences Reports the P-II (EDGE-Gastric) Trial Data on Domvanalimab + Yutuo (Zimberelimab) for Gastroesophageal Adenocarcinomas

Shots: Arcus has reported data from Arm A1 (n=41) of the P-II (EDGE-Gastric) trial assessing domvanalimab (1600mg, IV, Q4W) + Yutuo (480mg, IV, Q4W) & CT in pts with locally advanced unresectable or metastatic G/GEJ or esophageal adenocarcinoma As of Mar 3, 2025 (mFU of 26.4mos.), pts showed 24mos. OS rate of 50.2% (mOS: 26.7mos.)…
October 13, 2025

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Zoetis
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Zoetis’ Lenivia (Izenivetmab) Receives the CVMP’s Recommendation for Osteoarthritis Pain Relief in Dogs

Shots: The CVMP has recommended Lenivia for the reduction of pain associated with osteoarthritis in dogs, with EC’s decision expected in Q4’25. Also, a commercial launch in the EU is planned for 2026 Lenivia showed increased mobility & decreased pain after a single administration in a 9mos. field study, along with favorable safety in dogs…
October 13, 2025

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