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

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

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

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

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

BMS to Strengthen its Cell Therapy Portfolio with $1.5B Orbital Therapeutics Acquisition

Shots: BMS has entered into a definitive agreement to acquire Orbital, strengthening & diversifying its cell therapy portfolio As per the deal, BMS will acquire Orbital, incl. its asset, OTX-201 & RNA platform, in an all-cash transaction of $1.5B OTX-201 is a preclinical circular RNA therapy encoding a CD19 CAR for in vivo expression delivered via…

October 13, 2025

Adcendo’s ADCE-D01 Receives the US FDA’s Fast Track Designation to Treat Soft Tissue Sarcoma

Shots: The US FDA has granted FTD to ADCE-D01 for the treatment of soft tissue sarcoma (STS) ADCE-D01 is being evaluated in P-I/II (ADCElerate1/EUCT) dose escalation & expansion study as a monotx. for metastatic &/or unresectable STS, with enrolment ongoing in the US & EU ADCE-D01 is an ADC targeting uPARAP & conjugated to the…

October 10, 2025

Ono Pharmaceutical Reports the P-II (ONO-4578-08) Trial Findings of ONO-4578 in Gastric or Gastroesophageal Junction (G/GEJ) Cancer

Shots: Ono Pharmaceutical has reported the P-II (ONO-4578-08) trial findings of ONO-4578 (EP4 antagonist) regimen for previously untreated, HER2-negative unresectable advanced or recurrent G/GEJ cancer ONO-4578-08 assessed ONO-4578 (40mg, QD, PO) + Opdivo (360mg, Q3W) & CT (S-1 + Oxa or CapOx) vs PBO + Opdivo & CT in G/GEJ cancer pts across Japan, South Korea…

October 10, 2025

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across Canada

Shots: Bio-Thera Solutions has entered into an exclusive commercialization & license agreement with Intas Pharmaceuticals for BAT2506, a biosimilar version of Simponi (golimumab), for Canada The agreement expands their Feb 2025 deal, under which Intas holds US commercialization rights for BAT2506, while Bio-Thera handles its development & manufacturing BAT2506 is an IgG1 monoclonal antibody that targets…

October 10, 2025

Phibro Animal Health Collaborates with Lighthouse Pharmaceuticals for Novel Canine Periodontal Therapy

Shots: Phibro Animal Health has entered into a licensing agreement with Lighthouse Pharmaceuticals to develop & commercialize a therapeutic asset targeting periodontal health in companion animals As per the agreement, Phibro will obtain exclusive rights to develop, manufacture, and commercialize Lighthouse Pharma’s proprietary compound for canine periodontal care, though financial terms were not disclosed The…

October 10, 2025

NEWS

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

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

Surgical Theater’s SyncAR Spine Platform Secures the US FDA’s 510(k) Clearance for Spine Surgery

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

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

BMS to Strengthen its Cell Therapy Portfolio with $1.5B Orbital Therapeutics Acquisition

Adcendo’s ADCE-D01 Receives the US FDA’s Fast Track Designation to Treat Soft Tissue Sarcoma

Ono Pharmaceutical Reports the P-II (ONO-4578-08) Trial Findings of ONO-4578 in Gastric or Gastroesophageal Junction (G/GEJ) Cancer

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across Canada

Phibro Animal Health Collaborates with Lighthouse Pharmaceuticals for Novel Canine Periodontal Therapy

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