Merck KGaA (Merck) has announced an investment of more than €300m ($320.8m) in a new Life Science Research Center at its global headquarters in Darmstadt, Germany. Set to open in 2027, the centre will be a hub for developing biopharmaceuticals, including antibodies and messenger ribonucleic acid applications. The investment is part of Merck’s broader €1.5bn commitment to the Darmstadt site by 2025. Covering an area of 18,000m², the Advanced Research Center will consolidate efforts on key life science technologies such as the production of antibodies, recombinant proteins, and viral vectors. It allows collaboration across departments of the company in an open, modern work environment. The facility will also focus on the advancement of cell culture media, pharmaceutical formulation, purification aids, and analytical chromatography. Merck said the new centre will support both European and global customers in addressing significant medical challenges. Merck CEO and executive board chair Belén Garijo said: “With ...
Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5 billion acquisition of Acceleron Pharma. By FRANK VINLUANPulmonary arterial hypertension, a disease that leads to worsening lung and heart problems that eventually become life-threatening, is treated with drugs that alleviate symptoms. FDA approval of a new Merck drug marks the first for a therapy addressing an underlying cause of the disease. The Tuesday approval of the Merck drug covers the treatment of adults whose pulmonary arterial hypertension (PAH) is at intermediate or high risk of progression. The drug, known in development as sotatercept, will be marketed under the brand name Winrevair. Hypertension—high blood pressure—is common. PAH is a rare form of hypertension that specifically affects the arteries carrying blood from the right side of the heart and into the lungs. ...
Up to 20% of prostate cancer cases are classified as castration-resistant AstraZeneca (AZ) and Merck & Co – known as MSD outside the US and Canada – have announced that the Scottish Medicines Consortium (SMC) has approved Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC). Affecting around one in ten men in Scotland, approximately 10% to 20% of prostate cancer cases are classified as castration resistant, evolving to resist androgen deprivation therapy, the standard of care. mCRPC occurs when the cancer has spread to other parts of the body, which is challenging to treat and results in a poor prognosis. The SMC’s decision was based on results from the phase 3 randomised, double-blind PROpel trial, which evaluated the efficacy, safety and tolerability of Lynparza versus placebo when given in addition to abiraterone in men with mCRPC who had ...
Rowe, N.J., March 13, 2024 – Merck Sharp & Dohme (Merck is the corporate trading name of Merck & Co. of Rowe, N.J., U.S.A.) announced at the European Organization for the Study of Genital Infections and Neoplasms (EUROGIN) Congress 2024 plans to initiate a novel multivalent human papillomavirus (HPV) vaccine clinical trial designed to provide broader protection against HPV types. At the same time, Merck Sharp & Dohme also plans to conduct additional clinical trials to evaluate the protective efficacy and safety of Gardasil®9 [nine-valent human papillomavirus vaccine (brewer’s yeast)] single-dose regimen1 compared to the already approved three-dose regimen. Within China, Gardasil®9 is indicated for the prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical intraepithelial neoplasia (CIN grades 1/2/3) and adenocarcinoma in situ (AIS) of the uterine cervix caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and ...
Despite declines in sales and EPS, Merck recorded a stable dividend of €2.20 per share for both 2023 and the preceding year. Merck’s EBITDA dropped by 15.6% from €6.504bn in 2022 to €5.489bn in 2023. Credit: Merck KGaA, Darmstadt, Germany and/or its affiliates. Merck KGaA (Merck) has reported a decline in financial performance for the fiscal year 2023, with net income attributable to shareholders falling by 15.1% to €2.82bn ($3.07bn), compared to €3.326bn in the previous year. Earnings per share (EPS) also saw a decrease of 15.2% to €6.49 from €7.65 in 2022. Group net sales experienced a downturn of 5.6% to €20.99bn from €22.23bn in 2022. The company has cited foreign exchange effects, particularly from the US dollar and the Chinese renminbi, as having a negative 4.1% impact on sales. Earnings before interest, taxes, depreciation and amortisation, a key financial indicator for business operations, also dropped by 15.6% from ...
Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. Keytruda slashed the risk of death by 38% compared with placebo when used after kidney removal in patients with clear cell renal carcinoma, the most common form of kidney cancer, according to newly released trial results. After four years of treatment, investigators estimated that 91.2% of patients in the Keytruda arm were still alive, versus 86% for the control group. The results, which reached statistical significance, come from an update of the Keynote-564 trial. Previously, disease-free survival results from the same trial supported Keytruda’s 2021 approval as an adjuvant therapy for certain kidney cancer patients at risk of recurrence after surgery. Keytruda’s survival win comes just as Bristol Myers Squibb’s rival PD-1 inhibitor, Opdivo, failed for a second time in ...
With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. have agreed to join their counterpart at Bristol Myers Squibb in testifying before the Senate Committee on Health, Education, Labor and Pensions (HELP). Friday, the HELP Committee’s chairman, Sen. Bernie Sanders (I-Vt.), said J&J’s Joaquin Duato and Merck’s Robert Davis have “reconsidered their positions” and have agreed to join BMS’ CEO Chris Boerner at a committee hearing scheduled for February 8. Duato and Davis’ cooperation comes shortly Sanders said the HELP Committee would vote to subpoena the CEOs after they declined a previous invitation to talk drug pricing. That subpoena vote has now been called off, the Committee said in a press release Friday. Sanders’ HELP Committee has already been crusading against steep drug prices over the past year. The committee has already heard testimony from chief executives ...
After crowning Keytruda as the first immunotherapy for advanced cervical cancer back in 2021, the FDA has awarded the drug another industry-first designation in an earlier stage of the tumor type. But again, the achievement was not perfect for Merck. Thanks to a new FDA nod, Merck’s Keytruda is the first PD-1 drug to be approved in combination with chemoradiotherapy to treat patients with stage 3 to 4a cervical cancer, the New Jersey pharma giant said Friday. This marks Keytruda’s 39th indication in the U.S. The approval, however, was narrower than expected. It came on the back of results from the Keynote-A18 trial, which showed a tumor progression benefit for the Keytruda-chemoradiation regimen in a broader patient population with earlier-stage cervical cancer. Keynote-A18 tested the Keytruda combo in patients whose cancer was as early as stage 1b2. Among the entire trial population, adding Keytruda to chemoradiotherapy slashed the risk of ...
While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.” Make no mistake, given Keytruda’s size, an overall business decline will likely still hit. But Merck is focused on making “the hill to dip as small as possible and the return to growth as fast as possible,” Davis said Monday at the 2024 annual J.P. Morgan Healthcare Conference. Davis and Merck Research Laboratories President Dean Li, M.D., Ph.D., pointed to the breadth of Merck’s portfolio across oncology, infectious disease, cardiometabolic, immunology and neuroscience to explain Merck’s potential for growth. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. 2028, it’s just another year, it’s just another point. We’re focused on 2030 to 2040.” At last year’s J.P. ...
Pharmaceutical Executive Editorial Staff Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy. Findings from the KEYNOTE-942/mRNA-4157-P201 clinical trial show that Moderna’s investigational individualized neoantigen therapy plus Merck’s Keytruda (pembrolizumab) lowered the risk of death or relapse by nearly half in patients with resected high-risk melanoma (stage III/IV) following complete resection. A planned analysis of the Phase IIb randomized trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival (RFS) by lowering the risk of recurrence or death by 49% compared with Keytruda monotherapy. “As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda ...
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