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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…
NEWS
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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;…
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…
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The US FDA has approved Tauklarify (florquinitau F 18 injection/ MK-6240) for PET of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify pts with tau neurofibrillary tangle (NFT) pathology
Approval was supported by Study 1 & 2 assessing Tauklarify (IV, 185 MBq) PET images from >500…
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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…
Shots:
The US FDA has approved ziresovir (AK0529) for a P-II trial in the severely ill RSV infected infant patients, including those in the pediatric intensive care unit (PICU)
The trial will compare ziresovir with PBO to evaluate clinical efficacy, particularly oxygen-treatment duration & sustained recovery time, generating data to support future registrational trials
In…
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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,…
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The EMA has validated the MAA for PF-07307405, a 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate and will begin its assessment of the application developed in collaboration between Pfizer & Valneva
The application is supported by >70% efficacy in the P-III (VALOR) trial, which evaluated PF-07307405 in individuals aged ≥5 years.…
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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,…
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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;…

