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FDA has approved Padcev (enfortumab vedotin-ejfv) + Keytruda or Keytruda Qlex for neoadj. & adj. treatment for cisplatin-ineligible pts with MIBC, before the PDUFA action date (Apr 07, 2026)
Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B…
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In 2025, the global Prescription Drugs market is projected to generate an impressive $1.13T, with steady annual growth of 3.94% expected through 2030, ultimately reaching $1.37T. Leading the pack is Keytruda, securing the first position with $29.48B, closely followed by Ozempic at $28.18B, and Eliquis, which recorded $20.69B in global sales. Fourth position is…
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Merck has reported topline P-II (CADENCE) trial data assessing Winrevair (sotatercept-csrk; 0.3 or 0.7mg/kg) vs PBO in 164 pts with CpcPH due to heart failure with preserved ejection fraction (HFpEF)
Trial met its 1EP, showing a reduction in pulmonary vascular resistance at 24wks. along with a favorable safety profile. Data will be presented at a…
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Merck has signed a definitive agreement to acquire Cidara Therapeutics through a subsidiary, adding the company’s lead late-stage antiviral candidate CD388 to its pipeline
Merck will acquire Cidara at $221.50 per share in cash, valuing the deal at approximately $9.2B. The transaction is expected to close in Q1’26
Cidara’s CD388 (currently in P-III) is…
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Merck has highlighted P-III (CORALreef HeFH) trial data assessing enlicitide decanoate (20mg, PO, QD) vs PBO in 303 adults with HeFH at AHA’25
Trial showed significant LDL-C reductions (1EP), along with decreases in non-HDL-C (53%), ApoB (49.1%), & Lp(a) (27.5%) at Wk. 24 in HeFH pts on stable background lipid-lowering therapy. High adherence (97%) &…
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Daiichi Sankyo and Merck reported efficacy results for raludotatug deruxtecan (R-DXd) in patients with recurrent Pt.-resistant ovarian, primary peritoneal, or fallopian tube cancer from the P-II (dose-optimization) part of the REJOICE-Ovarian01 P-II/III study
Across all doses (4.8 mg/kg, 5.6 mg/kg, and 6.4 mg/kg), ORR was 50.5% (n=107) as assessed by BICR, with 3 complete…
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Merck has reported P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in Pt-resistant recurrent ovarian cancer pts (n=643)
Trial met its 2EP of improved OS in pts with PD-L1+ tumors, building on previously reported data, which will be presented at ESMO’25;…
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The P-III (HYPERION) trial assessed Winrevair vs PBO, both with background therapy in recently diagnosed adults (n=320) with PAH (WHO Group 1) FC II or III at intermediate or high risk of disease progression
Trial showed 76% reduction in clinical worsening, where 10.6% vs 36.9% pts experienced ≥1 event, with treatment benefit seen in…
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Evaxion has granted Merck the rights to EVX-B3, a preclinical vaccine candidate under their Sep 2024 option & license agreement
As per the deal, Merck will assume full responsibility & costs of further development of EVX-B3 in exchange for $7.5M upfront & ~$592M in development, regulatory & sales milestones, with net sales-based royalties
EVX-B3…
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Variational AI has entered into a collaboration with Merck to design and optimize novel small molecule candidates against two undisclosed targets using Variational AI’s Enki platform
As per the deal, Variational AI will leverage its fine-tuned Enki platform trained on Merck’s proprietary data to generate & optimize small-molecule candidates for Merck’s targets, with Merck…

