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The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the 1L treatment of patients with HER2+ positive unresectable or metastatic breast cancer.
MAA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer…
NEWS
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The company has reported dosing of the first patient in the US P-III (BiPASS) trial evaluating its PSMA-PET imaging agents, Illuccix and Gozellix, for use in the initial diagnosis of prostate cancer
BiPASSa P-III study enrolling 250 pts in the US and Australia to support marketing authorization of 68Ga-PSMA-PET in the pre-biopsy setting
Building…
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Data from the OLE 503 study of Caplyta & pooled results from P-III (Studies 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant, in adults with MDD presented at ANCP’26
Pooled data showed higher remission (MADRS ≤10) with treatment at 6wks. (25.5% vs 13.6%), with complete remission (MADRS ≤5) in 10.6%…
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AbbVie has reported topline P-III (EPCORE DLBCL-1) trial results assessing epcoritamab vs chemoimmunotherapy (R-GemOx or BR) in 483 adults with r/r DLBCL, who had received ≥1L of therapy (73% had received ≥2L) & were ineligible for HDT-ASCT
Trial showed improved PFS, with improvements across CRR, DoR, & time to next treatment, plus the study did not…
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FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor
The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…
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AstraZeneca to acquire AbelZeta’s 50% stake in the China development & commercialization rights to C-CAR031, securing full global rights to develop, manufacture, & commercialize C-CAR031 worldwide
Under a prior agreement, AstraZeneca secured global rights to develop, manufacture, & commercialize C-CAR031 outside China, while AbelZeta remains eligible for additional development milestones & royalties tied to…
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The EC approved Aspaveli (pegcetacoplan) for pts (≥12yrs.) with C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), to be used with a RAS inhibitor unless such therapy is contraindicated or not tolerated
Approval was based on P-III (VALIANT) trial assessing Aspaveli(twice weekly) vs PBO in C3G or primary IC-MPGN pts (≥12yrs., n=124) for…
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The US FDA has granted 510(k) clearance for the EnCor EnCompass Breast Biopsy and Tissue Removal System to provide clinicians with flexibility across breast imaging modalities in the diagnosis of breast disease
The EnCor EnCompass Biopsy System streamlines breast biopsy procedures by allowing clinicians to use a single integrated system across multiple imaging platforms,…
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Ocugen has reported preliminary 12mos. data from its P-II (ArMaDa) trial (n=51) of OCU410 (AAV5-RORA) in GA secondary to dry AMD, with ~50% of pts evaluated to date
Trial showed a 46% reduction in GA lesion growth vs control (medium + high dose), with the medium dose achieving a 54% reduction; 50% pts achieved…
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Boston Scientific has entered into a definitive agreement to acquire Penumbra, expanding its cardiovascular portfolio
As per the deal, Boston Scientific will acquire Penumbra for $374/share, with Penumbra stockholders having the option to receive either $374 in cash or 3.8721 shares of Boston Scientific’s common stock, representing the enterprise value of ~$14.5B; closing expected…

