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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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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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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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BioNTech (NASDAQ: BNTX), the biotech giant recognized for its role in developing the COVID-19 vaccine, has acquired Biotheus for an upfront payment of $800 million, with additional milestone payments potentially reaching up to $150 million. Founded in 2018 and headquartered in Zhuhai, China, Biotheus has developed eight clinical-stage products and…
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Merck KGaA (NYSE: MRK), the German multinational science and technology company, has released its financial results for the third quarter of 2024, reporting net sales of EUR 5.266 billion (USD 5.55 billion), marking an organic growth of 3.8%. The company’s performance reflects a steady increase in sales across its business…
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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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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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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, 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, 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 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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Merck KGaA (MRK, NYSE: MRK) , a leading science and technology company based in Germany, has announced the availability of its ovulation-stimulating treatment Pergoveris in the Guangdong–Hong Kong–Macao Greater Bay Area. The treatment, which combines recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH), has been approved…
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US pharmaceutical giant Merck & Co., Inc. (MRK, NYSE: MRK) has announced that the Phase III KEYNOTE-689 study for its PD-1 inhibitor Keytruda (pembrolizumab) has met its primary endpoint of event-free survival (EFS) in patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell…
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the commercial availability of TEVIMBRA (Tislelizumab) in the United States following its approval by the FDA for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy. The drug received FDA approval in March…
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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…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced its financial results for the first half of 2024, reporting a 32.2% year-on-year (YOY) increase in revenues to RMB 1.383 billion, which includes a USD 90 million cooperation payment from its U.S. partner Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK),.…
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Global healthcare leaders Merck, Sharp & Dohme Inc.(MSD; NYSE: MRK), known as MSD outside the US and Canada, and Daiichi Sankyo (TYO: 4568) have announced that their jointly developed anti-HER3 antibody drug conjugate (ADC), patritumab deruxtecan, has demonstrated a significant progression-free survival (PFS) benefit in the Phase III HERTHENA-Lung02 trial.…
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Merck & Co., Inc. (NYSE: MRK), a leading US pharmaceutical company, has announced that its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab), has received expanded approval in China. The updated approval allows the drug’s package insert to be revised to include “pembrolizumab is suitable for the treatment of unresectable or metastatic…
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Merck (NYSE: MRK) and Daiichi Sankyo (TYO: 4568) announced that their antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd) has passed Phase 3 HERTHENA-Lung 02 study, months after the drug was rejected by the U.S. FDA due to manufacturing issues following its presentation at this year’s ESMO conference. The companies will discuss…
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Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK), a leading U.S. pharmaceutical company, and its co-development partner Daiichi Sankyo (TYO: 4568), have announced preliminary data from a Phase II clinical trial for the investigational B7-H3-directed antibody-drug conjugate (ADC) ifinatamab deruxtecan. The trial has identified a recommended dosage of 12mg/kg for…
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Merck & Co., Inc. (NYSE: MRK), a global healthcare leader based in the United States, has announced that the European Commission (EC) has granted approval for the use of Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin) as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma. This…
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SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its HLX17, a biosimilar version of MSD’s (Merck & Co., known as MSD outside the US) blockbuster drug Keytruda (pembrolizumab). The biosimilar targets all indications that the…
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US-based Merck, Sharp & Dohme Inc. (NYSE: MRK) announced the discontinuation of two Phase III trials evaluating its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) in new indications, due to insufficient efficacy. The decisions to halt the trials were made following recommendations from their respective independent data monitoring committees. The trials…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic acquisition agreement with Shanghai-based biotech firm Curon Biopharmaceutical. Under the terms of the deal, MSD will fully acquire CN201, a cutting-edge CD3 x CD19-targeted T-cell-engager bispecific antibody (BsAb). The transaction includes an upfront payment of USD 700 million, with…
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Merck KGaA (FRA: MRK) has reported its financial results for the second quarter of 2024, showing a 1.7% increase in global net sales to €5.4 billion (USD 5.9 billion) over the three-month period. The company’s performance varied by business segment, with Life Science experiencing a decline of 3.7% year-on-year in…
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CybernaX, a biotechnology company based in Nanjing, has entered into a comprehensive licensing agreement with the German pharmaceutical and chemical giant Merck KGaA (FRA: MRK). The agreement pertains to CybernaX’s proprietary technology for efficient lipid storage. While the financial details of the transaction remain undisclosed, the partnership signals a significant…
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Daiichi Sankyo (TYO: 4568), a Japanese pharmaceutical company, has announced an expansion of its strategic partnership with U.S.-based Merck, Sharp & Dohme (MSD; NYSE: MRK) to include global co-development of an antibody drug conjugate (ADC). This extension incorporates a new T-cell engager, MK-6079, which MSD acquired as part of its…
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has reported its financial results for the second quarter of 2024, with global revenues reaching USD 16.1 billion, marking an 11% increase year-on-year when excluding currency impacts. Despite this growth, the company’s stock price declined by 9.81% as investors reacted to the…
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I-Mab (NASDAQ: IMAB), a clinical-stage biopharmaceutical company, has announced significant changes to its leadership structure. Wei Fu, currently the CEO of venture capital fund CBC Group and I-Mab’s founding shareholder, has been appointed as the chairman of the board. Fu succeeds Dr. Pamela M. Klein, who is stepping down from…
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German pharmaceutical giant Merck KGaA (ETR: MRK) has announced the commencement of commercial manufacturing of its first Good Manufacturing Practice (GMP) compliant cell culture medium (CCM) production line in China. This strategic expansion into the Chinese market is a response to the growing demand for high-quality, customized CCM solutions. Merck’s…
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Roche (SWX: ROG; SWX: RO; OTCMKTS: RHHBY), the Swiss pharmaceutical giant, has announced that a Phase II/III clinical trial for its TIGIT-targeted antibody tiragolumab, designed for non-small cell lung cancer (NSCLC), did not outperform Keytruda (pembrolizumab), a PD-1 inhibitor. The trial, known as SKYSCRAPER-06, was evaluating the efficacy of tiragolumab…
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Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
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Merck KGaA (NYSE: MRK), a leading German pharmaceutical company, has encountered a setback in the Phase III clinical trial for xevinapant, a drug licensed from Debiopharm in a deal valued at over USD 1 billion in 2021. The drug, which combines with chemoradiotherapy (CRT), was being investigated in the TrilynX…
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK), a leading U.S. pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine). The vaccine is indicated to prevent invasive disease caused by a range of Streptococcus pneumoniae serotypes in adults,…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has granted an additional indication for its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab). The drug is now approved for use in combination with chemotherapy for adults with primary advanced or recurrent endometrial carcinoma,…
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Merck KGaA (ETR: MRK), the German life science and technology company, announced last week a significant expansion of its life science distribution center in Germany, increasing the facility’s size by 25,000 square meters. This €180 million ($194 million) investment bolsters the center’s capabilities with additional filling lines and global distribution…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an equity investment into DELFI Diagnostics, a U.S.-based developer of blood-based cancer tests, without disclosing the financial terms. The investment will enable DELFI to further develop its fragmentomics and artificial intelligence technologies, enhancing early cancer detection and treatment monitoring. DELFI’s proprietary…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that Tang Xiaochun, who served as the head of vaccine business and assistant vice-president at MSD China, has left the company. Tang initially joined MSD China in 2018 as the executive director of the company’s oncology medical affairs department. During his…
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QuantumPharm Inc., operating under the name Xtalpi Inc., has successfully conducted an initial public offering (IPO) on the Hong Kong Stock Exchange, raising HKD 1.13 billion (USD 144.5 million). The shares of Xtalpi, listed under the ticker symbol 02228, were priced at HKD 6.03 per share. Xtalpi is a pioneer…
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FiercePharma.com has reported on the reactions of multinational corporation executives to the recent news that Akeso Biopharma (HKG: 9926) and partner Summit Therapeutics’ ivonescimab, a PD-1/VEGF bispecific antibody (BsAb), has become the first molecule to outperform Merck Sharp & Dohme’s (MSD) leading PD-1 therapy Keytruda (pembrolizumab) in a head-to-head trial…
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Eli Lilly and Company (NYSE: LLY) has presented an update on a Phase I/II clinical trial for its KRAS inhibitor, olomorasib, in patients with KRAS G12C-mutant advanced solid tumors. The trial also explores the combination of olomorasib with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) top-selling checkpoint inhibitor, Keytruda (pembrolizumab),…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has entered into an agreement to acquire UK-based ophthalmology specialist Eyebiotech Limited for an upfront payment of USD 1.3 billion, plus potential milestone payments of up to USD 1.7 billion. The deal is anticipated to be finalized in the third quarter of 2024,…
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Burning Rock Ltd (NASDAQ: BNR), a China-based medical technology company, has announced another partnership in the field of tumor companion diagnostics (CDx), this time with the German multinational corporation, Bayer. Previously Burning Rock had collaborated with Germany-based Merck KGaA in late 2021 for the development of CDx to support Merck’s…
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Merck KGaA (ETR: MRK), the German science and technology company, has commenced construction on a new bioprocessing plant in South Korea with a groundbreaking ceremony. This initiative represents Merck’s largest single investment in the Asia-Pacific region, exceeding USD 300 million. The construction follows a memorandum of understanding with the Ministry…
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Merck, Sharp & Dohme (MSD; NYSE: MRK), the producer of the leading checkpoint inhibitor Keytruda (pembrolizumab), has entered into a collaborative agreement with Dragonfly Therapeutics for the combination therapy of Keytruda and Dragonfly’s tri-specific natural killer (NK) cell engager, DF9001. The partnership aims to explore treatment options for advanced solid…
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Merck KGaA (NYSE: MRK)’s US life sciences division, MilliporeSigma, has been at the center of a US Department of Justice (DoJ) investigation into the fraudulent sale and export of biochemicals, including cocaine and fentanyl, to China. The scheme, which lasted from July 2016 until its discovery in May 2023, involved…
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Germany’s Merck KGaA (ETR: MRK) has announced that its Switzerland-based subsidiary, Ares Trading, has entered into a partnership with US-based Aulos Bioscience. This collaboration aims to advance the clinical development of Merck’s anti-PD-L1 drug Bavencio (avelumab) in combination with Aulos’s anti-IL-2 antibody candidate, AU-007. The financial details of the agreement…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced its decision to cease development of the anti-TIGIT antibody vibostolimab in combination with its anti-PD-1 drug Keytruda (pembrolizumab) as an adjuvant treatment for resected high-risk melanoma. This strategic move follows an interim analysis that failed to meet the primary endpoint of…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that a late-stage trial for its blockbuster drug Keytruda (pembrolizumab) as an adjuvant treatment in newly diagnosed, high-risk endometrial cancer failed to meet the primary endpoint of disease-free survival (DFS). Although the analysis of the co-primary endpoint of overall survival (OS)…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has released its financial report for the first quarter of 2024, announcing sales of USD 15.8 billion, an increase of 11% year-on-year (YOY) excluding the impact of foreign exchange rates. The pharmaceutical division contributed USD 14.0 billion to the top line, with a…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a partnership with South Korea’s Hanmi Pharmaceutical (KRX: 128940) to develop a combination therapy using MSD’s top-selling anti-PD-1 therapy Keytruda (pembrolizumab) and Hanmi’s bispecific antibody (BsAb) BH3120 for the treatment of progressive or metastatic solid tumors. The financial details of the…
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a global healthcare leader, has entered into a strategic collaboration with GV20 Therapeutics, a biopharmaceutical company specializing in antibody therapeutics with operations in both China and the U.S. The partnership aims to combine GV20’s groundbreaking IGSF8-targeted biologic, GV20-0251, with MSD’s best-selling anti-PD-1 therapy,…
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Easton Pharmaceutical Co., Ltd (SHA: 688513), based in Chengdu, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Concor, which contains bisoprolol and amlodipine, a compound preparation used as an alternative therapy for hypertension. The approval signifies that Easton’s…
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Global healthcare leader Merck, Sharp & Dohme (MSD) (NYSE: MRK) has secured a strategic acquisition of Abceutics, a preclinical biopharmaceutical startup focused on optimizing antibody-drug conjugates (ADCs). The financial details of the transaction remain undisclosed. Abceutics has developed a series of payload-binding selectivity enhancers (PBSEs) designed to increase the safety…
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German pharmaceutical giant Merck (ETR: MRK) has entered into a strategic collaboration with Caris Life Sciences’ research unit, Caris Discovery, to uncover novel oncology targets and develop first-in-class antibody-drug conjugates (ADCs). The partnership aims to harness Caris’ precision medicine expertise and Merck’s ADC technology to accelerate the discovery and development…
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Merck KGaA (ETR: MRK), a leading German technology company, has announced the completion of the M Lab Collaboration Center in Shanghai, which is the largest among its global network of 10 such centers. This significant expansion represents an additional investment of EUR 14 million, resulting in the addition of a…
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The US Food and Drug Administration (FDA) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) regulatory approval for Winrevair (sotatercept), marking it as the first activin signaling inhibitor for the treatment of pulmonary arterial hypertension (PAH) in adults. This milestone concludes a review process under the breakthrough therapy designation…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an unfavorable outcome for a Phase III trial combining Keytruda (pembrolizumab) and Lynparza (olaparib) in the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC). The study, which aimed to evaluate the efficacy of this combination therapy, was halted after…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has entered into a strategic agreement with Pearl Bio, a synthetic biology company, to leverage Pearl’s genomically recoded organisms (GROs) platform. This platform is designed for the discovery and development of biologic molecules that incorporate non-standard amino acids, enabling the targeting of previously…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a partnership with IDEAYA Biosciences (NASDAQ: IDYA), a US-based biotechnology company, to clinically develop the combination of MSD’s top-selling anti-PD-1 therapy Keytruda (pembrolizumab) with IDEAYA’s potential first-in-class poly (ADP-ribose) glycohydrolase (PARG) inhibitor IDE161. The collaboration focuses on treating microsatellite instability-high (MSI-high)…
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Merck KGaA (ETR: MRK), a leading German chemical, reported a 5.6% decline in its global net sales for the fiscal year 2023, amounting to €21.0 billion ($23.0 billion). This contraction was partially attributed to the adverse impact of foreign exchange rates. The company’s Healthcare division, however, posted a 2.7% increase…
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Gilead Sciences Inc. (NASDAQ: GILD) and Merck & Co., Inc., known as MSD (NYSE: MRK), have this week unveiled preliminary findings from a Phase II clinical trial of their investigational antiretroviral combination therapy, islatravir plus lenacapavir, as a potential once-weekly oral treatment for HIV/AIDS. Despite the primary endpoint being influenced…
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Merck (NYSE: MRK), a Germany-headquartered science and technology company, has entered into a partnership with C4 Therapeutics (NASDAQ: CCCC), a U.S.-based protein degradation, to discover two targeted protein degraders aimed at oncogenic proteins of interest. Merck will be responsible for funding the research expenses of the programs and has agreed…
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Merck KGaA (ETR: MRK), a German multinational pharmaceutical, chemical, and life sciences company, has this week unveiled new clinical data for its cytotoxic drug Mavenclad (cladribine) in the treatment of highly active relapsing multiple sclerosis (RMS). The results indicate that over 95% of participants noted clinically meaningful improvements in cognitive…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) has announced the initiation of clinical trials for SKB264 (MK-2870), an antibody-drug conjugate (ADC) co-developed with Merck, Sharp & Dohme (MSD, NYSE: MRK) for the treatment of non-small cell lung cancer (NSCLC) and endometrial carcinoma (EC). This development triggers a clinical milestone payment…
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The Center for Drug Evaluation (CDE) website has indicated that Merck, Sharp & Dohme’s (MSD; NYSE: MRK) belzutifan and Sperogenix Therapeutics Ltd’s vamorolone are on track to receive priority review statuses in China. Belzutifan, which targets von Hippel Lindau (VHL) disease-associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma,…
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This week, the U.S. FDA granted priority review status to an indication extension filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) for its blockbuster drug Keytruda (pembrolizumab), seeking approval as a treatment for primary advanced or recurrent endometrial carcinoma, the most prevalent gynecological cancer. The FDA anticipates reaching a…
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Merck KGaA (ETR: MRK), a leading German technology company, last week inaugurated a digital hub in Singapore, marking its first such initiative outside of Europe and the US. This new digital hub will leverage collaboration platforms Syntropy and Athinia to enhance data analytics capabilities, aiming to spur innovation and research…
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Merck KGaA (NYSE: MRK), a leading German science and technology company, has announced the commercial launch of its targeted lung cancer therapy, Tepmetko (tepotinib), in China. This marks a significant milestone as multiple hospitals across the country have begun writing the first prescriptions for this MET inhibitor. Tepmetko, which has…
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading US pharmaceutical company, has released its financial report for the fourth quarter and full year of 2023. In Q4, MSD generated USD 14.6 billion in sales, marking a 6% year-on-year increase, with growth expanding to 13% when excluding the impacts from…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has embarked on a collaborative project with Canadian company Variational AI to leverage the latter’s generative AI-powered model for drug discovery initiatives. Through this partnership, MSD will have early access to Variational AI’s platform, which utilizes text prompts to generate novel small molecules…
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The Hangzhou Yuhang District People’s Court has released a document indicating that BJ Bioscience Inc.’s application for bankruptcy liquidation has been accepted for review. The Hangzhou-based firm becomes the first domestic biotech company to face insolvency this year. Established in 2018, BJ Bio focused on research and development (R&D) of…
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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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German pharmaceutical company Merck (NYSE: MRK) has released data from real-world studies for its anti-PD-L1 biologic Bavencio (avelumab), used as a maintenance therapy in eligible patients with locally advanced or metastatic urothelial carcinoma (UC). Preliminary results indicate that the median overall survival (OS) in patients without progression after first-line chemotherapy…
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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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Germany-based Merck (NYSE: MRK) has in-licensed the potential first-in-class candidate ompenaclid from U.S. firm Inspirna, aimed at inhibiting the creatine transport channel SLC6A8. The drug is currently undergoing Phase II trials for RAS-mutated advanced or metastatic colorectal cancer (mCRC). The agreement also encompasses additional follow-on compounds targeting SLC6A8. In return…
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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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French pharmaceutical giant Sanofi (NASDAQ: SNY) has expanded its partnership with UK-based AI-driven precision drug design company Exscientia (NASDAQ: EXAI) by in-licensing a program in an undisclosed therapeutic area. This move builds on a 2022 agreement aimed at developing up to 15 novel small-molecule candidates across oncology and immunology. The…
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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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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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Coherus Biosciences Inc. (NASDAQ: CHRS) announced yesterday in an SEC filing the wholesale price for its newly launched PD-1 inhibitor, Loqtorzi (toripalimab), in the U.S. market. The drug, co-developed under license from Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877; SHA: 688180), will retail at $8,892.03 per single-use vial. Loqtorzi received…
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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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Germany’s major life science company, Merck KGaA (ETR: MRK), has announced the completion of the second phase of its new EUR 29 million (USD 32 million) Biologics Testing Center in China. This expansion adds 1,500 square meters to the lab, which initially opened its doors last year. Marking the first…
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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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Germany’s Merck KGaA (ETR: MRK), a leading player in the global pharmaceutical industry, has this week unveiled its strategic plans for the US healthcare market. The company, which currently commercializes two cancer treatments in the US, is gearing up to launch two additional drugs by 2025. Furthermore, Merck anticipates continuing…
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Germany-based Merck (ETR: MRK) has released its financial results for the third quarter of 2023, revealing a 4.1% year-on-year (YOY) decline in organic sales, totaling EUR 5.2 billion (USD 5.5 billion) for the three-month period. The results highlight a challenging environment, with only the Healthcare division showing growth. The Healthcare…
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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…
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has released the results of a Phase II study combining its antibody drug conjugate (ADC) Adcetris (brentuximab vedotin) with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy Keytruda (pembrolizumab). The study focused on patients with…
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US-based pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) has reported a robust 9% year-on-year (YOY) increase in global sales for Q3 2023, reaching USD 15.9 billion. This strong performance has led the firm to raise its full-year sales forecast to a range of USD 59.7 billion to USD…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of two Phase II trials evaluating the efficacy of its glutamate modulator MK-1942 in patients with mild-to-moderate Alzheimer’s disease (AD) and treatment-resistant major depressive disorder (MDD). The decision comes after an unblinded data analysis indicated potential safety concerns. Trial…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic collaboration agreement with Japan-based Daiichi Sankyo (TYO: 4568) focused on the development and commercialization of three potential first-in-class deruxtecan-based antibody-drug conjugate (ADC) candidates. This partnership aims to advance innovative treatments for various types of cancer. ADC Candidates and Development…
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German pharmaceutical giant Merck KGaA (ETR: MRK) has entered into a strategic partnership with China-based Contract Development and Manufacturing Organization (CDMO) Porton Pharma Solutions’ Shanghai unit. The collaboration aims to develop a next-generation integrated antibody drug conjugate (ADC) platform technology, marking a significant step in the advancement of oncology treatments.…
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Global pharmaceutical leader Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic partnership with US-based biotechnology firm Phanes Therapeutics to develop a novel combination therapy. The collaboration will see MSD’s anti-PD-1 blockbuster Keytruda (pembrolizumab) paired with Phanes’s first-in-class CD47×claudin 18.2 drug PT886, targeting claudin 18.2-positive gastric or gastroesophageal…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that a late-stage trial for its anti-PD-1 drug Keytruda (pembrolizumab) has successfully met the primary endpoint of statistically significant and clinically meaningful improvement in overall survival (OS) in patients with resectable non-small cell lung cancer (NSCLC). The trial evaluated Keytruda as…
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Yu Yuping, a seasoned professional with a distinguished career at AstraZeneca (AZ, NASDAQ: AZN), has reportedly taken on a new role at German pharmaceutical giant Merck KGaA (ETR: MRK). He has been appointed as the vice-president of Merck’s China medicine and health business, where he will lead the Cardiovascular, Metabolic,…
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading global pharmaceutical company, last week released clinical data from separate late-stage studies for its anti-PD-1 biologic, Keytruda (pembrolizumab), in combination with other oncology therapies from different partners. The results presented a mixed picture of success and challenges in the field of…
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German pharmaceutical company Merck (NYSE: MRK) has announced two separate strategic collaborations with UK-based artificial intelligence-driven precision drug design companies BenevolentAI (AMS: BAI) and Exscientia (NASDAQ: EXAI). These partnerships aim to discover potential first-in-class and best-in-class small-molecule therapies in the fields of oncology, neurology, and immunology. Terms of Collaboration and…
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The US Food and Drug Administration (FDA) has granted priority review status to an indication extension application filed by Merck, Sharp & Dohme (MSD; NYSE: MRK) for its oral HIF-2α inhibitor Welireg (belzutifan). The application seeks approval for the treatment of advanced renal cell carcinoma (RCC) in adults who have…
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy, Keytruda (pembrolizumab), as an adjuvant treatment for non-small cell lung cancer (NSCLC) in adults who are at a high risk of…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has presented interim data from Phase III and extension studies for its potential first-in-class biologic sotatercept, which is being investigated for the treatment of pulmonary arterial hypertension (PAH). The late-stage trial indicated that the activin signaling inhibitor led to a reduction in right…
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Gilead (NASDAQ: GILD) has announced interim data from a Phase II trial assessing the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in combination with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 Keytruda (pembrolizumab) for first-line advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. The interim results…
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US pharmaceutical major Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has officially registered a unit in the Lecheng pilot zone of Boao, Hainan province, marking a significant milestone as the first multinational company to obtain a business license in the city. Hainan Boao Lecheng International Medical Tourism Pilot Zone’s…