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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its blockbuster anti-PD-1 drug Keytruda (pembrolizumab) has entered a Phase Ia/b trial in combination with South Korea-based PharmAbcine’s (KOSDAQ: 208340) VISTA-inhibiting biologic PMC-309 for the treatment of advanced or metastatic solid tumors. The study aims to determine the recommended dose,…
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Gilead Sciences (NASDAQ: GILD) has announced that a late-stage trial for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in metastatic or advanced non-small cell lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS) in patients who had previously received treatment for metastatic NSCLC. Despite this setback,…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has received regulatory approval from the US Food and Drug Administration (FDA) for the use of its anti-PD-1 drug Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 stage III-IVA cervical cancer. This marks…
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C4 Therapeutics (NASDAQ: CCCC), a leader in protein degradation, announced this week its strategic focus for 2024, which includes a significant reduction of 30% in its workforce. The U.S.-based company will prioritize ongoing Phase I/II trials for CFT7455 and CFT1946, targeting relapsed/refractory multiple myeloma (r/rMM) and BRAF V600X-mutant solid tumors,…
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a prominent pharmaceutical company in the U.S., has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its recombinant human papillomavirus (HPV) 9-valent vaccine, Gardasil 9. The vaccine is now approved for a two-dose vaccination schedule (0,…
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading U.S. pharmaceutical company, has announced its intention to acquire Harpoon Therapeutics (NASDAQ: HARP) for approximately USD 680 million. The acquisition is expected to be completed in the first half of 2024, subject to approval by Harpoon’s stockholders and the fulfillment of…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced significant progress in its oncology pipeline with the advancement of four candidates to late-stage trials that are currently enrolling participants. The first molecule is the LSD1 inhibitor bomedemstat, which is being developed for the treatment of essential thrombocythemia (ET). Nemtabrutinib, a…
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The US Food and Drug Administration (FDA) has accepted under priority review a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) and Daiichi Sankyo (TYO: 4568) for their jointly developed antibody-drug conjugate (ADC) patritumab deruxtecan. The treatment is intended for patients with locally advanced or metastatic EGFR-mutated non-small cell…
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The US Food and Drug Administration (FDA) has declined to approve a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) for its P2X3 receptor antagonist, gefapixant, which was being considered as a treatment for refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. The rejection was due…
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US pharmaceutical company Merck, Sharp & Dohme (MSD; NYSE: MRK) has entered into a partnership with French firm Owkin to develop and commercialize a pre-screening procedure for identifying the microsatellite instability- (MSI) H biomarker in various cancers. The initiative aims to test for MSI-H in endometrial, gastric, small intestinal, and…
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The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) additional indications for its leading anti-PD-1 therapy, Keytruda (pembrolizumab), approving its use as a first-line treatment in combination with chemotherapy for locally advanced unresectable or metastatic biliary tract carcinoma (BTC) and HER2-negative gastric or gastroesophageal junction (GEJ)…
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US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its immunotherapy drug Keytruda (pembrolizumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication. The drug is now approved as a first-line treatment for locally advanced unresectable or metastatic HER2-negative…
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Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp & Dohme (MSD; NYSE: MRK) have secured U.S. Food and Drug Administration (FDA) approval for their combination therapy consisting of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer (la/mUC). The FDA’s decision is…
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The US Food and Drug Administration (FDA) has granted an indication extension approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan), expanding its use as a therapy for advanced renal cell carcinoma (RCC) in adults who have previously received a PD-1/L1 inhibitor and a VEGF tyrosine…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of a Phase III trial for its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with AstraZeneca’s (AZ; NASDAQ: AZN) co-developed PARP inhibitor Lynparza (olaparib) for metastatic squamous non-small cell lung cancer (NSCLC). The decision follows the trial’s failure to meet…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced plans to transition a significant portion of its IT infrastructure to Amazon Web Services (AWS), a move aimed at enhancing efficiency in drug discovery and clinical trial development. This multiyear initiative, revealed by parent company Amazon (NASDAQ: AMZN) this week, will…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has unveiled new data from a late-stage trial of its 21-valent pneumococcal conjugate vaccine, V116, confirming earlier topline results. The data, released this week, highlights the vaccine’s immunogenicity, tolerability, and safety in comparison to Pfizer’s (NYSE: PFE) 20-valent Prevnar 20/Apexxnar in unvaccinated adults.…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an agreement to purchase Caraway Therapeutics, a US-based pre-clinical company, for a potential total of USD 610 million, which includes upfront and milestone payments. This acquisition will enhance MSD’s portfolio with a range of small-molecule candidates targeting neurodegenerative and rare diseases.…
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India-based Aurobindo Pharma reportedly received EU GMP approval for its China-based manufacturing plant last week, as reported by The Hindu Times. The site is anticipated to start generating revenues from the end of Q4 of the company’s fiscal year (FY) 2024 or early in Q1 FY 2025. Manufacturing and Market…
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The 6th China International Import Expo (CIIE) held in Shanghai this week has been a platform for multiple companies to announce their strategic partnerships in China. Among the notable participants are Danaher (NYSE: DHR), Boehringer-Ingelheim (BI), Merck Sharp & Dohme (MSD, NYSE: MRK), Johnson & Johnson (J&J, NYSE: JNJ), BeiGene…