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Merck and Moderna Report the INTerpath-001 Trial Data on Intismeran Autogene + Keytruda for Completely Resected Stage IIB-IV Melanoma

Shots: Merck & Moderna have reported the P-III (INTerpath-001) trial data assessing adj. intismeran autogene (1mg, Q3W for 9 doses) + Keytruda (400mg, Q6W up to 9 cycles) vs Keytruda alone in 1,137 pts with high-risk (stage IIB-IV) resected cutaneous melanoma Intismeran plus Keytruda as adj. therapy showed improvements in RFS (1EP) and DMFS (2EP)…

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Merck, Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Cisplatin-Eligible MIBC Patients

Shots: The US FDA has approved Padcev (enfortumab vedotin) + Keytruda/Keytruda Qlex for neoadj. & adj. treatment for pts with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility Approval was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC…

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Merck KGaA to Acquire Bio-Techne for ~$11.3B

Shots: Merck KGaA has entered into a definitive agreement to acquire Bio-Techne, bringing together two companies with complementary portfolios spanning research tools, diagnostics, bioprocessing, and advanced therapeutics As per the deal, Merck KGaA will acquire Bio-Techne for $73/share in cash, representing a total enterprise value of ~$11.3B; closing is expected by late 2026 or early…

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Merck Receives EC Approval for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: The EC has approved Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC across all 30 EEA states Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or Arm C (neoadj. & adj. Keytruda + Padcev)…

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The US FDA Expands Merck’s Capvaxive Use to Children and Adolescents Aged 2-17 at Increased Risk for Pneumococcal Disease

Shots: The US FDA has expanded the indication for Capvaxive to incl. pts aged 2–17yrs. with certain chronic medical conditions who have completed a primary pediatric pneumococcal vaccination series & remain at increased risk of pneumococcal disease Approval was supported by P-III (STRIDE-13) trial data, which compared Capvaxive with PPSV23 in the above-mentioned pts Capvaxive…

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Protillion Biosciences and Merck Enter ~$510M Drug Discovery Collaboration

Shots: Protillion has entered into a multi-target discovery collaboration & license agreement with Merck, integrating Protillion’s Prot-MaP technology with Merck’s global expertise in the discovery of novel therapeutic candidates As per the deal, Protillion will receive an undisclosed upfront payment & ~$510M in research, development, & commercial milestone payments for the successful development of multiple…

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