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MSD Halts Development of Vibostolimab and Favezelimab Due to Trial Setbacks
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US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has revealed its decision to terminate the clinical development of vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody, following recent disappointing data from Phase III trials. Discontinuation of Vibostolimab TrialsThe Phase III KeyVibe-003 and KeyVibe-007 studies, which were assessing…
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European CHMP Supports Conditional Approval of MSD’s Welireg for VHL Disease and RCC
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for its Welireg (belzutifan), a hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. The CHMP recommends conditional approval for adult patients with von Hippel-Lindau (VHL) disease…
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AstraZeneca’s Lynparza Shows Sustained Improvements in OlympiA Phase III Study
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UK pharmaceutical major AstraZeneca (AZ; NASDAQ: AZN) has updated data from the Phase III OlympiA study for its PARP inhibitor Lynparza (olaparib) at the San Antonio Breast Cancer Symposium 2024 (SABCS). The study provides significant insights into the efficacy and safety of Lynparza in patients with germline BRCA-mutated (gBRCAm) HER2-negative…
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Merck’s PD-1 Inhibitor Keytruda Approved by NMPA for Cervical Cancer Treatment in China
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US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its PD-1 inhibitor Keytruda (pembrolizumab). The approval allows the use of Keytruda in combination with chemotherapy for International Federation of Obstetrics and Gynecology (FIGO) 2014 stage III-IVA cervical…
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MSD’s Noxafil Receives NMPA Approval for Pediatric Use in Antifungal Treatment
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US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that China’s National Medical Products Administration (NMPA) has approved an extended indication for its antifungal agent Noxafil (posaconazole) to include pediatric patients in the prevention and treatment of fungal infections. This approval covers two dosage forms: enteric-coated tablets and…
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Sacituzumab Tirumotecan Earns FDA Breakthrough Therapy Designation for EGFR Mutated NSCLC
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Sacituzumab tirumotecan (SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC) co-developed by Merck, Sharp & Dohme (MSD, NYSE: MRK) and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has been granted a breakthrough therapy designation (BTD) by the US FDA. This designation is for the treatment of non-small cell lung cancer (NSCLC)…
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Merck’s Recarbrio Approved by NMPA for Hospital-Acquired Infections and Complicated UTIs
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US pharmaceutical major Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its combination antibacterial drug, Recarbrio (imipenem, cilastatin, and relebactam). This new treatment is indicated for patients aged 18 years and older with hospital-acquired…
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MSD Partners with Cancer Foundation of China for HPV Vaccine Donation Program
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has entered into a donation agreement with the Cancer Foundation of China (CFC) to support a cervical cancer prevention and control program. Under this agreement, MSD will donate a total of 81,000 doses of the human papillomavirus (HPV) vaccine to the CFC. The…
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MSD China to Streamline Diabetes Business Amid Volume-Based Procurement Inclusion
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The China unit of US pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) is reportedly streamlining its diabetes business through redundancies, according to local media outlet Yicai. This move is a response to the anticipated impact of the inclusion of its sitagliptin and other drugs in China’s volume-based…
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China Grants Marketing Approval for MSD’s Welireg for von Hippel-Lindau Disease Tumors
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China’s National Medical Products Administration has issued marketing approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan) as a therapy for von Hippel-Lindau (VHL) disease-related renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma, and pancreatic neuroendocrine tumor (pNET) that do not require immediate surgical intervention.…
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MSD Announces Positive Topline Results from Phase III Subcutaneous Keytruda Trial
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US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has released positive topline results from the pivotal Phase III MK-3475A-D77 trial. The study aimed to assess the noninferiority of subcutaneous administration of PD-1 inhibitor Keytruda (pembrolizumab) combined with berahyaluronidase alfa, a hyaluronidase variant developed by Alteogen Inc., in comparison to…
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LaNova Medicines Inks Licensing Deal with Sino Biopharmaceutical for Cancer Therapies in China
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Shanghai-based LaNova Medicines Ltd, a developer of cancer therapies, has announced another licensing deal, signing an agreement with compatriot firm Sino Biopharmaceutical Ltd (HKG: 1177) for the development and commercialization of LM-108 and other potential bispecific antibodies (BsAbs) and antibody drug conjugates (ADCs) in mainland China. The specifics of the…
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EMA’s CHMP Recommends Approval for MSD’s Keytruda Combo in Mesothelioma Treatment
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Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of its PD-1 inhibitor, Keytruda (pembrolizumab), in combination with pemetrexed plus…
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Merck Secures Exclusive Rights to LaNova’s PD-1/VEGF Bispecific Antibody LM-299
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US pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced a significant licensing agreement with Shanghai-based LaNova Medicines Ltd, a developer of innovative cancer therapies. This deal grants Merck exclusive global rights to develop, manufacture, and commercialize LaNova’s LM-299, a novel PD-1/VEGF bispecific antibody (BsAb), marking a…
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MSD Reports 4% YOY Revenue Increase in Q3 2024, Led by Pharmaceutical Sector
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US pharmaceutical giant Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK) has released its financial report for the third quarter of 2024, highlighting a 4% year-on-year (YOY) increase in revenues to USD 1.67 billion. The Pharmaceutical sector experienced a 5% YOY growth, reaching USD 14.943 billion, while the Animal Health…
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Merck and Moderna Launch Phase III Study for Individualized Neoantigen Therapy in Lung Cancer
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US pharmaceutical companies Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) and Moderna Inc. (NASDAQ: MRNA) have initiated the Phase III INTerpath-009 study to evaluate V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab). The study will focus on patients with resectable Stage…
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Merck’s Keytruda Gains Two Additional EU Indications for Gynecologic Cancer Treatment
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Merck, Sharp & Dohme Inc., known as MSD (NYSE: MRK), has received two additional indication approvals from the European Union for its immunotherapy drug Keytruda (pembrolizumab), increasing the total number of approved uses in the region to 30. The PD-1 inhibitor is now approved for use in combination with carboplatin…
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Merck Acquires Modifi Biosciences to Target DNA Repair Defects in Cancer Therapies
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK), a leading U.S. pharmaceutical company, has bolstered its oncology pipeline through the acquisition of Modifi Biosciences, Inc., a biotechnology company specializing in direct DNA modification-enabled cancer therapeutics. This strategic move provides MSD with preclinical compounds aimed at exploiting DNA repair defects in…
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Westgene Biopharma’s Pioneering mRNA Vaccine for EBV-Related Tumors Clears IND Hurdle in China
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Westgene Biopharma has received approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China for its new drug research application (IND) for “WGc-043 Injection.” The approval, dated August 6, 2024, grants Westgene Biopharma the green light to initiate Phase I clinical trials. “WGc-043…
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FDA Panel Weighs in on Narrowing Use of PD-1 Inhibitors in Stomach and Esophageal Cancers
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The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) convened on September 26 to scrutinize the application of PD-1 inhibitors in oncology, particularly focusing on Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) and Merck, Sharp & Dohme’s (NYSE: MRK) Keytruda (pembrolizumab). The committee evaluated the risk-benefit profile of these drugs for…
