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Hutchmed
HUTCHMED and AstraZeneca Report P-III (SAFFRON) Trial Data on Orpathys + Tagrisso for MET-Driven EGFRm Lung Cancer
Shots: The P-III (SAFFRON) trial assessed Orpathys (300mg; BID) + Tagrisso (80mg; QD) vs doublet Pt-based CT in 338 pts with EGFRm, LA/M NSCLC with MET overexpression or amplification whose disease progressed following 1 or 2L treatment with Tagrisso The trial showed a statistically significant & clinically meaningful improvement in both PFS & OS, with a favorable…
Astrazeneca and Daiichi-Sankyo New
Daiichi Sankyo and AstraZeneca Report P-III (DESTINY-Lung04) Trial Data on Enhertu for HER2 Mutant Non-Squamous NSCLC
Shots: Daiichi Sankyo & AZ have reported P-III (DESTINY-Lung04) trial data assessing Enhertu (5.4mg/kg) vs SoC (Pt-pemetrexed doublet CT + Keytruda) in 454 pts with unresectable, locally advanced or metastatic, nsq-NSCLC harboring a HER2 exon 19 or 20 mutation Trial showed that Enhertu improved PFS as 1L treatment, with trial continuing to evaluate 2EPs incl. OS;…
Sandoz & Henlius
Henlius and Sandoz Partner on Up to 10 Biosimilar mAbs and ADC Products
Shots: The deal incl. ~10 biosimilars or related components, incl. 3 initial assets: HLX05-N (cetuximab), HLX16 (evolocumab), & a proposed belimumab biosimilar, plus an option for HLXTE-HAase1001, a recombinant human hyaluronidase Sandoz will receive exclusive rights to register & commercialize the assets globally outside China, with both parties sharing development & lifecycle activities. Territories vary…
Rigel Reports Availability of Veppanu for ER+/HER2-, ESR1-Mutated Breast Cancer
Shots: Rigel has reported the availability of Veppanu (vepdegestrant) by prescription in the US for the treatment of adults with ER+/ HER2-, ESR1-mutated advanced or metastatic breast cancer, with disease progression following ≥1L of endocrine therapy Veppanu (200mg, PO, QD) is an FDA-approved PROTAC, a class of targeted protein degraders that uses the body’s natural machinery to…
Zoetis
Zoetis’ Simparica Trio Receives FDA’s EUA for Treating New World Screwworm Infestations in Dogs and Puppies
Shots: The US FDA has granted Emergency Use Authorization (EUA) to Simparica Trio (sarolaner, moxidectin, and pyrantel chewable tablets)for the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs & puppies Simparica Trio is an all-in-one monthly chewable for dogs, providing protection against heartworm disease, ticks, fleas, roundworms, & hookworms,…
Vesalio Receives FDA 510(k) Clearance for pVasc NET Peripheral Thrombectomy Device
Shots: Vesalio has received the US FDA 510(k) clearance for pVasc NET, a next-generation peripheral mechanical thrombectomy device with an integrated distal filter  pVasc NET builds on the pVasc platform, a self-expanding nitinol device delivered through a low-profile catheter for non-surgical removal of emboli & thrombi from peripheral blood vessels pVasc NET features a fine-pore,…
BMS
BMS Reports the US FDA Accelerated Approval for Zenbexus (Iberdomide) Combination in R/R Multiple Myeloma (MM)
Shots: FDA has granted accelerated approval to Zenbexus (iberdomide) + daratumumab & hyaluronidase-fihj + dexamethasone (ZDd) for the treatment of pts with MM who received ≥1L of prior therapy incl. a proteasome inhibitor & an immunomodulatory agent Approval was supported by the P-III (EXCALIBER-RRMM) trial assessing ZDd (n=207) vs daratumumab + bortezomib + dexamethasone (DVd;…