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Merck & Co.’s Winrevair Approved for Pulmonary Arterial Hypertension in Hainan
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US-based giant Merck & Co., Inc. (NYSE: MRK) announced receiving approval from the Hainan Medical Products Administration for its Winrevair (sotatercept-csrk) to be imported by Shanghai Ruijin Hospital’s Hainan subsidiary. This approval is significant as it provides a new treatment option for patients with pulmonary arterial hypertension (PAH) in China.…
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BioCity and MSD Enter Clinical Collaboration for BC3195 and Keytruda Combination Trial
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China-based BioCity Biopharmaceutics Co., Ltd. announced a clinical collaboration agreement with US-based giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK). The partnership will initiate a global Phase I/II study to evaluate the safety and efficacy of BioCity’s BC3195 in combination with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) for patients with…
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Merck Sharp & Dohme Expands Durham Facility with $1B Investment for Vaccine Production
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US-based giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced the opening of a 225,000 sq. ft. extension to its manufacturing facility in Durham, North Carolina. The expansion, which has received a USD1 billion investment, will focus on vaccine manufacturing and is a key part of MSD’s ongoing commitment…
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MSD China Reorganizes to Boost Mature Product Lines
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Anna Van Acker, Senior Vice-President of Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) and President of MSD China, announced this week a significant adjustment to the company’s organizational structure. A new entrepreneur business unit will be established, focusing on the US giant’s mature products in the fields of infection,…
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Adagene Starts Phase II Trial of Muzastotug for Colorectal Cancer
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China-based Adagene Inc. (NASDAQ: ADAG) announced the initiation of an Investigator-Initiated (IIT) Phase II trial for muzastotug (ADG126) as a neoadjuvant therapy for patients with stage II or stage III colorectal cancer. Drug ProfileMuzastotug is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells…
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Merck’s Keytruda sBLA for LA-HNSCC Accepted by FDA for Review
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Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for review. The application seeks approval for Keytruda’s use in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC)…
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Epitopea and Merck Partner to Identify Cryptigen Tumor Antigens
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UK-based RNA immunotherapy developer Epitopea announced a licensing and research cooperation agreement with US pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK). The partnership aims to identify Cryptigen tumor-specific antigens (TSAs) in an undisclosed solid tumor. These antigens, derived from non-coding regions of the genome, are shared, non-mutated, and…
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Merck’s Welireg Wins Conditional EU Approval for VHL Disease and Advanced RCC
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US pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that it has received conditional approval from the European Commission (EC) for its oral drug Welireg (belzutifan) for the treatment of von Hippel-Lindau (VHL) disease and advanced clear cell renal cell carcinoma (RCC). Drug ProfileWelireg is a hypoxia-inducible factor-2…
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Merck’s Zerbaxa Approved by China’s NMPA for Complex Infections
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US-based pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its antibiotic Zerbaxa (ceftolozane, tazobactam). The fixed-dose combination antibiotic medication is approved to treat a range of complex infections in both adult and pediatric…
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Merck Initiates Phase III waveLINE-010 Study for Zilovertamab Vedotin in DLBCL
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US-based pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced the initiation of the pivotal Phase III waveLINE-010 study. This study is designed to assess zilovertamab vedotin, an investigational antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), in combination with rituximab plus cyclophosphamide, doxorubicin, and…
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MSD Reports Strong Global Sales Growth in 2024, Despite China Challenges
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US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) released its Q4 2024 financial report, highlighting strong global revenue growth. Global revenues reached USD 15.6 billion in Q4, up 9% year-on-year (YOY) excluding currency impacts. Over the full year, revenues increased 10% to USD 64.17 billion. The growth was driven…
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Betta Pharmaceuticals Gains NMPA Approval for BPI-452080 Clinical Study
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its BPI-452080 in von Hippel-Lindau (VHL) syndrome-related tumors and solid tumors. This marks a significant step forward in the development of new treatments for…
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MSD and Eisai’s Keytruda/Lenvima Combo Shows Promise in Gastroesophageal Cancer Study
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Partners Merck, Sharp & Dohme (MSD, NYSE: MRK) and Eisai (TYO: 4523) have announced the latest results from the Phase III LEAP-015 study, which evaluated the combination of MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) with Eisai’s kinase inhibitor Lenvima (lenvatinib) plus chemotherapy. The study focused on the first-line treatment of patients…
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Eli Lilly and Merck Launch Consortium for Innovative Drug Manufacturing
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US-based Eli Lilly and Company (NYSE: LLY) and Merck & Co. Inc. (NYSE: MRK) have announced the launch of the Young Institute Pharmaceutical Manufacturing Consortium in collaboration with Purdue University. The initiative aims to develop new methods of drug manufacturing, driving technological innovation in the pharmaceutical industry. Consortium Focus and…
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Merck’s Keytruda Gains NMPA Approval for HNSCC Indication in China
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US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or…
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MSD’s Gardasil Vaccine Gains NMPA Approval for Use in Males Aged 9 to 26
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US major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its recombinant human papillomavirus (HPV) quadrivalent vaccine, Gardasil, for use in males aged 9 to 26. This approval expands the vaccine’s application to include prevention…
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WuXi Biologics to Sell Irish Vaccine Assets to MSD for USD 500 Million
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China-based Contract Research, Development and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) is poised to sell its assets related to vaccine facilities in Ireland to US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) for a consideration of USD 500 million. This strategic move reflects WuXi Biologics’ ongoing efforts…
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NMPA Approves Lynparza as Adjuvant Treatment for High-Risk Breast Cancer Patients
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The National Medical Products Administration (NMPA) in China has granted AstraZeneca (AZ, NASDAQ: AZN) and Merck, Sharp & Dohme (MSD; NYSE: MRK) a regulatory nod for their drug Lynparza (olaparib). The approval is for adjuvant treatment in adult patients with early high-risk breast cancer who have undergone neoadjuvant or adjuvant…
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MSD’s Clesrovimab for Infant RSV Protection: FDA Accepts BLA for Review
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company’s investigational prophylactic long-acting monoclonal antibody. This antibody is designed to protect infants from respiratory syncytial virus (RSV) disease during their first…
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Merck to Acquire HUB Organoids Holding B.V., Advancing Organoid Technology in Drug Development
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Merck (NYSE: MRK) has announced a definitive agreement with the intention to acquire HUB Organoids Holding B.V. (HUB), a company specializing in organoid technology. Organoids, which are cell culture models that functionally resemble organs, hold the potential to revolutionize drug development by accelerating processes, enhancing disease treatment understanding across diverse…
