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Merck-3
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Merck’s Welireg Receives the US FDA’s Approval for Pheochromocytoma and Paraganglioma

Shots:The US FDA has approved Welireg for the treatment of pts (≥12yrs.) with advanced, unresectable, or metastatic pheochromocytoma & paraganglioma (PPGL)Approval was based on Cohort A1 data from P-II (LITESPARK-015) trial assessing Welireg monotx. (120mg; QD) in 72 pts with unresectable or non-curable PPGL & stable blood pressure (BP <150/90 mm Hg, <135/85 mm…
May 15, 2025

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Merck
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Merck Reports P-III (KEYNOTE-689) Trial Data of Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma

Shots:The P-III (KEYNOTE-689) trial assessed neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (× 15 cycles) + SoC radiotherapy (RT) ± cisplatin vs adj. SoC RT without cisplatin in treatment-naïve pts (n=714) with stage III/IVA resected LA-HNSCC; sBLA under the FDA’s review (PDUFA: Jun 23, 2025)At 38.3 mos. mFU,…
April 28, 2025

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Merck
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Merck’s Keytruda Regimen Receives Health Canada’s Approval for Malignant Pleural Mesothelioma (MPM)

Shots:Health Canada has approved Keytruda + pemetrexed + Pt-based CT as 1L treatment of unresectable advanced or metastatic MPM based on P-II/III (IND.227/KEYNOTE-483) trial led by CCTG in collaboration with NCIN & IFCTTrial assessed the regimen in MPM pts (n=440) who received either Keytruda (200mg, IV) + pemetrexed (500mg/m^2) & Pt-based CT on Day…
April 23, 2025

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Merck & Cyprumed
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Merck Signs a ~$493M Deal with Cyprumed to Develop Oral Peptide Therapeutics

Shots:Cyprumed & Merck have entered into a non-exclusive license & option agreement to develop oral formulations of Merck’s peptides, leveraging Cyprumed’s innovative drug delivery tech As per the deal, Merck has secured non-exclusive global rights to Cyprumed’s oral peptide delivery platform for an undisclosed number of targets, with an option to exclusively license it…
April 15, 2025

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Merck
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Merck Secures the EC’s Approval for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for Invasive Pneumococcal Disease (IPD)

Shots:The EC has approved Capvaxive for active immunization against invasive disease & pneumonia caused by S. pneumoniae in adults (≥18yrs.) in 30 EEA statesApproval was backed by P-III (STRIDE-3) data, assessing Capvaxive vs PCV20 in pneumococcal vaccine-naïve adults (≥18yrs.), plus data from various P-III trials (STRIDE-4, STRIDE-5,  STRIDE-6, STRIDE-7, & STRIDE-10) assessing it in both vaccine-naïve & vaccinated adultsSTRIDE…
March 27, 2025

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Merck & Hengrui
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Merck Partners with Jiangsu Hengrui Pharmaceuticals for HRS-5346, Expanding its Cardio-Metabolic Portfolio

Shots:Merck has entered into an exclusive license agreement with Jiangsu Hengrui Pharmaceuticals for HRS-5346As per the deal, Merck has obtained exclusive rights to develop, manufacture & commercialize HRS-5346 globally excl. Greater China region in exchange for $200M upfront & ~$1.77B in development, regulatory & commercial milestones, along with net sales-based royalties; closing expected…
March 25, 2025

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