Merck & Co Inc (N:MRK)
Business Focus: Pharmaceuticals
May 15, 2024 06:45 am ET
Merck to Present New Data at 2024 ASCO Annual Meeting Demonstrating Advancements in Novel Oncology Treatment Approaches Across Broad Portfolio and Diverse Pipeline
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new data for four approved oncology medicines and four pipeline candidates in more than 25 types of cancer will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 31-June 4. New data being shared at the meeting showcase the company’s continued progress to advance clinical research for Merck’s broad portfolio and diverse pipeline of investigational candidates.
May 13, 2024 06:45 am ET
Merck Provides Update on Phase 3 KeyVibe-010 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab as Adjuvant Treatment for Patients With Resected High-Risk Melanoma
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial. The trial is evaluating the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, compared to KEYTRUDA alone, as adjuvant treatment for patients with resected high-risk melanoma (Stage IIB-IV). At a pre-planned analysis, data showed that the primary endpoint of recurrence-free survival (RFS) met the pre-specified
May 09, 2024 07:05 am ET
Health Canada Approves KEYTRUDA® for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma, in combination with gemcitabine-based chemotherapy
Approval is based on the Phase 3 KEYNOTE-966 Trial
May 09, 2024 06:45 am ET
Merck Provides Update on Phase 3 KEYNOTE-B21 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Radiotherapy, for Patients With Newly Diagnosed, High-Risk Endometrial Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-B21 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as adjuvant treatment, with or without radiotherapy, did not meet its primary endpoint of disease-free survival (DFS) for the treatment of patients with newly diagnosed, high-risk endometrial cancer after surgery with curative intent.
May 08, 2024 09:15 am ET
Merck Expands Access to High-Quality Maternal Care for More Than 30 Million Women Worldwide Through Merck for Mothers
Surpasses its goal of reaching 25 million women by 2025
May 08, 2024 08:30 am ET
Mitigating Muscle Loss Becoming More Vital, Global Cancer Cachexia Market Projected to Reach $3.3 Billion in 2024
FN Media Group News Commentary - There is much activity in finding better ways in mitigating muscle loss for the cancer patients… many clinical studies are looking for elite performance nutritional supplements to mitigate the muscle loss in these...
May 08, 2024 06:45 am ET
Merck to Participate in the Bank of America Securities 2024 Healthcare Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Caroline Litchfield, executive vice president and chief financial officer, is scheduled to participate in a fireside chat at the Bank of America Securities 2024 Healthcare Conference on Wednesday, May 15, 2024, at 1:40 p.m. PDT / 4:40 p.m. EDT.
Apr 25, 2024 06:30 am ET
Merck Announces First-Quarter 2024 Financial Results
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2024.
Apr 19, 2024 07:04 am ET
Health Canada Approves KEYTRUDA® as a first-line treatment for adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma i
Approval is based on the Phase 3 KEYNOTE-859 Trial
Apr 04, 2024 06:45 am ET
Merck Initiates Phase 3 Clinical Trial of MK-1084, an Investigational Oral KRAS G12C Inhibitor, in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Certain Patients With Metastat
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced it has initiated a Phase 3 clinical trial evaluating MK-1084, an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor KRAS G12C mutations and express PD-L1 (tumor proportion score [TPS] ≥50%).
Apr 03, 2024 08:00 am ET
REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug Deruxtecan Initiated in Patients with Platinum-Resistant Ovarian Cancer
Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the first patient has been dosed in the REJOICE-Ovarian01 phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resist
Apr 01, 2024 06:45 am ET
Merck to Hold First-Quarter 2024 Sales and Earnings Conference Call April 25
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its first-quarter 2024 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Thursday, April 25. During the call, company executives will provide an overview of Merck’s performance for the quarter.
Mar 28, 2024 09:15 am ET
How We Can Strengthen Vaccination Programs and Build Vaccine Confidence Together
Two Merck leaders share how their company is working to help protect communities from vaccine-preventable illnesses
Mar 28, 2024 06:45 am ET
European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for Resectable Non-Small Cell Lung Cance
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.
Mar 27, 2024 09:31 am ET
Thinking about buying stock in Diamondback Energy, Merck, High Tide, Rumble, or SNDL?
NEW YORK, March 27, 2024 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for FANG, MRK, HITI, RUM, and SNDL.
Mar 26, 2024 06:21 pm ET
FDA Approves Merck’s WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1)
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: WINREVAIR™, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. WINREVAIR was previously granted Breakthrough Therapy Designation by the FDA. WINREVAIR is the first FDA-approved activin signaling inhibitor thera
Mar 26, 2024 09:30 am ET
Merck Foundation Strengthens Its Commitment to Expanding Access to Care in Asia-Pacific Region
RAHWAY, NJ / ACCESSWIRE / March 26, 2024 / The Merck Foundation, a private charitable organization funded by Merck (NYSE:MRK), known as MSD outside of the United States and Canada, has made an $11 million, six-year (2023 - 2028) commitment to University of New Mexico Health (UNM Health) in support of its new initiative to bring high-quality care to an estimated 11 million people living with cancer in underserved communities throughout India, Indonesia, Malaysia and Vietnam. The new initiative aims to train and mentor more than 33,000 lo
Mar 21, 2024 06:45 am ET
Merck Provides Update on Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Nonsquamous Non-Small Cell Lung Cance
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYLYNK-006 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic nonsquamous non-small cell lung cancer (NSCLC).
Mar 19, 2024 09:00 am ET
Merck Announces Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive data from multiple Phase 3 studies evaluating V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine, at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Diseases (ISPPD) in Cape Town, South Africa.
Mar 15, 2024 06:45 am ET
Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy (CRT) Significantly Improved Overall Survival (OS) Versus CRT Alone in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) met its primary endpoint of overall survival (OS) for the treatment of newly diagnosed patients with high-risk locally advanced cervical cancer.
Mar 13, 2024 03:00 am ET
Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL®9
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today, at the EUROGIN 2024 HPV Congress, announced plans to initiate clinical development of a new investigational multi-valent HPV vaccine designed to provide broader protection against multiple HPV types. Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.
Mar 11, 2024 08:15 am ET
Merck Completes Acquisition of Harpoon Therapeutics, Inc.
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of Harpoon Therapeutics, Inc. (Nasdaq: HARP). Harpoon is now a wholly-owned subsidiary of Merck, and Harpoon’s common stock will no longer be publicly traded or listed on the Nasdaq Stock Market.
Mar 06, 2024 10:25 am ET
Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24
Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 2 clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class capsid inhibitor. These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections (
Mar 05, 2024 08:30 am ET
Increasing Incidence of Pancreatic Cancer Leading to a $6.85 Billion Dollar Market Size for New Treatments
FN Media Group News Commentary - Pancreatic cancer is one of the leading causes of cancer death globally. The increasing incidence of this cancer across the U.S. and other parts of the world is one of the factors driving the need for the drugs used...
Mar 05, 2024 06:45 am ET
Merck to Participate in the Barclays 26th Annual Global Healthcare Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Jannie Oosthuizen, president, Human Health U.S., is scheduled to participate in a fireside chat at the Barclays 26th Annual Global Healthcare Conference on Tuesday, March 12, 2024, at 3:05 p.m. EDT.
Mar 04, 2024 06:45 am ET
Merck to Participate in the Leerink Partners Global Biopharma Conference 2024
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, is scheduled to participate in a fireside chat at the Leerink Partners Global Biopharma Conference 2024 on Monday, March 11, 2024, at 12:40 p.m. ET.
Feb 27, 2024 06:45 am ET
Merck to Participate in the TD Cowen 44th Annual Health Care Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Joseph Romanelli, president, Human Health International, is scheduled to participate in a fireside chat at the TD Cowen 44th Annual Health Care Conference on Tuesday, March 5, 2024, at 1:30 p.m. ET.
Feb 23, 2024 06:20 am ET
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for the Treatment
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as a monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.
Feb 20, 2024 06:45 am ET
FDA Grants Priority Review to Merck's Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel), followed by KEYTRUDA as a single agent for the treatment of patients with primary advanced or recurrent endometrial carcinoma. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 21, 2024.
Feb 15, 2024 08:45 am ET
Global Fibromyalgia Treatment Market Expected to Reach $4.6 billion by 2032
FN Media Group News Commentary - Numerous reports indicate that the fibromyalgia treatment market is positioned to continue to grow at a substantial rate through the next decade. Fibromyalgia is a chronic condition whose symptoms severely impair...
Feb 13, 2024 11:45 am ET
Merck Is Inspiring Innovation Through Diversity and Inclusion
When we bring together people from different backgrounds, the possibilities for invention are endless
Feb 12, 2024 06:05 am ET
Health Canada Approves KEYTRUDA® in combination with trastuzumab and chemotherapy, as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-positive gastric or gast
Approval is based on the Phase 3 KEYNOTE-811 Trial
Feb 08, 2024 06:00 am ET
MERCK CANADA ANNOUNCES COLLABORATION WITH VECTOR INSTITUTE TO FURTHER ADVANCE ITS ARTIFICIAL INTELLIGENCE CAPABILITIES AND DRIVE INNOVATION IN HEALTHCARE
KIRKLAND, QC, Feb. 8, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, has entered into a multi-year agreement with the Vector Institute in Toronto, an independent not-for-profit corporation dedicated to advancing the field of artificial intelligence (AI) through world-class research. This agreement will allow Merck Canada to gain access to Vector's exceptional research capabilities and expertise in AI and engage with its robust and thriving ecosystem to drive innovation in healthcare.
Feb 05, 2024 06:33 am ET
Merck Animal Health to Acquire Elanco’s Aqua Business
Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced that it has signed a definitive agreement to acquire the aqua business of Elanco Animal Health Incorporated (NYSE: ELAN) for $1.3 billion in cash, consisting of an innovative portfolio of medicines and vaccines, nutritionals and supplements for aquatic species; two related aqua manufacturing facilities in Canada and Vietnam; as well as a research facility in Chile. The acquisition is expected to be completed by mid-year 2024, su
Feb 05, 2024 05:33 am ET
Elanco Announces Sale of Aqua Business for $1.3 Billion
Transaction reinforces Elanco's commitment to most significant value creation opportunities in pet health and livestock sustainability
Feb 01, 2024 06:30 am ET
Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2023.
Jan 29, 2024 08:45 am ET
The Wall Street Journal Names Merck Among Top 10 Best-Managed Companies
We're proud to be recognized for our strong performance and unwavering commitment to patients
Jan 27, 2024 10:00 am ET
Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk of Death by 38% Versus Placebo as Adjuvant Therapy for Patients With Renal Cell Carcinoma (RCC) at an Increased Risk of Recurrence Following Nephrect
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. These late-breaking data are being presented during an oral session for the first time today at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (abstract #LBA359) and are in
Jan 26, 2024 12:15 pm ET
Unexpected Inspiration for More Sustainable Drug Development at Merck
NORTHAMPTON, MA / ACCESSWIRE / January 26, 2024 / Inspiration for a greener world can come from unexpected places. For Merck scientist François Lévesque, it came from the pet store. This is the amazing story of how creativity and Green Chemistry made drug development more sustainable.
Jan 26, 2024 10:00 am ET
Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Disease-Free Survival (DFS) as Adjuvant Therapy Versus Observation in High-Risk Patients With Localized Muscle-Invasive and Locally Advanced Ur
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 AMBASSADOR (A031501)/KEYNOTE-123 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of high-risk patients with localized muscle-invasive urothelial carcinoma (MIUC) and locally advanced resectable urothelial carcinoma. These late-breaking data are being presented for the first time today during an oral abstract session at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (abstract #LBA531).
Jan 23, 2024 02:44 pm ET
Merck Announces Second-Quarter 2024 Dividend
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Board of Directors has declared a quarterly dividend of $0.77 per share of the company’s common stock for the second quarter of 2024. Payment will be made on April 5, 2024, to shareholders of record at the close of business on March 15, 2024.
Jan 19, 2024 06:45 am ET
Merck to Hold Fourth-Quarter and Full-Year 2023 Sales and Earnings Conference Call Feb. 1
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its fourth-quarter and full-year 2023 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Thursday, Feb. 1. During the call, company executives will provide an overview of Merck’s performance for the fourth quarter and outlook for 2024.
Jan 16, 2024 08:05 am ET
BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Ambrx Biopharma, Inc. (Nasdaq – AMAM), Gracell Biotechnologies Inc. (Nasdaq – GRCL), Axonics, Inc. (Nasdaq - AX
Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky ([email protected]) or Marc Ackerman ([email protected]) at 855-576-4847. There is no...
Jan 15, 2024 07:15 am ET
Merck Animal Health's Fourth Veterinary Wellbeing Study Indicates Progress in Addressing Mental Health Challenges Among Veterinary Teams
More veterinary professionals are provided access to and are pursuing mental health resources for their overall wellbeing with continued improvements on the horizon
Jan 12, 2024 05:30 pm ET
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. The approval is based on data from the Phase 3 KEYNOTE-A18 trial, in which KEYTRUDA plus CRT demonstrated an improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 41% (HR=0.59 [95% CI, 0.43-0.82
Jan 08, 2024 05:31 pm ET
BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Ambrx Biopharma, Inc. (Nasdaq – AMAM), Gracell Biotechnologies Inc. (Nasdaq – GRCL), Axonics, Inc. (Nasdaq - AX
Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky ([email protected]) or Marc Ackerman ([email protected]) at 855-576-4847. There is no...
Jan 08, 2024 07:30 am ET
Merck to Acquire Harpoon Therapeutics, Further Diversifying Oncology Pipeline
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Harpoon Therapeutics, Inc. (Nasdaq: HARP) today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Harpoon for $23.00 per share in cash for an approximate total equity value of $680 million.
Jan 05, 2024 06:45 am ET
Merck Announces Phase 3 Trial Initiations for Four Investigational Candidates From its Promising Hematology and Oncology Pipeline
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of pivotal Phase 3 trials for four of its investigational candidates from its diverse pipeline in hematologic malignancies and solid tumors. Global Phase 3 studies have been initiated and are actively enrolling for the following investigational candidates:
Jan 03, 2024 06:45 am ET
Merck to Participate in the 42nd Annual J.P. Morgan Healthcare Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Robert M. Davis, chairman and chief executive officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, Jan. 8, 2024, at 4:30 p.m. PST / 7:30 p.m. EST.
Dec 22, 2023 08:00 am ET
Patritumab Deruxtecan Granted Priority Review in the U.S. for Certain Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
Daiichi Sankyo (TSE: 4568) and Merck (known as MSD outside of the United States and Canada) (NYSE: MRK) announced today that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.
Dec 21, 2023 06:05 am ET
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Receive Public Listing for Patients with Advanced Endometrial Carcinoma (EC) that is not MSI-H or dMMR
KIRKLAND, QC, and MISSISSAUGA, ON, Dec. 21, 2023 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai announce that KEYTRUDA®, Merck's anti-PD-1 therapy, plus LENVIMA®, an orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, is now reimbursed with clinical criteria and conditions under the British Columbia, Alberta, Saskatchewan, Ontario, Quebec, Nova Scotia, New Brunswick, and Newfoundland drug plans, for adult patients with advanced endometrial carcinoma (EC) that is not microsatellite instability high (MSI-H) or mismatch repa
Dec 20, 2023 04:30 pm ET
Merck Provides U.S. Regulatory Update on Gefapixant
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. In the CRL, the FDA concluded that Merck’s application did not meet substantial evidence of effectiveness for treating RCC and UCC. The CRL was not related to the saf
Dec 20, 2023 06:45 am ET
Merck to Participate in the Goldman Sachs Healthcare C-Suite Unscripted Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Robert M. Davis, chairman and chief executive officer, is scheduled to participate in a fireside chat at the Goldman Sachs Healthcare C-Suite Unscripted Conference on Thursday, Jan. 4, 2024, at 12:45 p.m. EST.
Dec 19, 2023 06:45 am ET
FDA Grants Priority Review to Merck’s New Biologics License Application for V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults
“Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease. We look forward to discussing the data that support our filing with the FDA and
Dec 18, 2023 06:45 am ET
European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for New First-Line Indications in Advanced HER2-Negative Gastric or GEJ Adenocarcinoma in Tumors Expressing PD-L1 (CPS
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Commission (EC) has approved two new indications for KEYTRUDA, Merck’s anti-PD-1 therapy, in gastrointestinal cancers:
Dec 15, 2023 05:00 pm ET
FDA Approves Expanded Indication for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Adult Patients With Locally Advanced or Metastatic Urothelial Canc
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. The FDA approved this application nearly five months ahead of the PDUFA goal date of May 9, 2024.
Dec 14, 2023 07:00 pm ET
FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
Dec 14, 2023 06:30 am ET
Moderna And Merck Announce mRNA-4157 (V940) In Combination with Keytruda(R) (Pembrolizumab) Demonstrated Continued Improvement in Recurrence-Free Survival and Distant Metastasis-Free Survival in Patie
At a median planned follow-up of approximately three years, mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 49% (HR=0.510 [95% CI, 0.288-0.906]; one-sided nominal p=0.0095) and the risk of distant metastasis or death by 62% (HR=0.384 [95% CI, 0.172-0.858]; one-sided nominal p= 0.0077) compared to KEYTRUDA alone in stage III/IV melanoma patients with high risk of recurrence following complete resection
Dec 13, 2023 04:55 pm ET
Merck Ranks No. 1 on Newsweek’s List of America’s Most Responsible Companies 2024
RAHWAY, N.J. / ACCESSWIRE / December 13, 2023 / Merck (NYSE:MRK), known as MSD outside of the United States and Canada, has earned the top spot on Newsweek's annual list of America's Most Responsible Companies, ranking No. 1 overall for the first time and establishing itself as an industry leader for the second consecutive year. Notably, Merck has also received the unique distinction of being the only company on the 2024 list to score 100/100 in corporate governance, which, in addition to disclosures and transparency, comprises economic
Dec 11, 2023 06:45 am ET
Merck and Moderna Initiate INTerpath-002, a Phase 3 Study Evaluating V940 (mRNA-4157) in Combination with KEYTRUDA® (pembrolizumab) for Adjuvant Treatment of Patients with Certain Types of Resected No
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Moderna, Inc. (Nasdaq: MRNA), today announced the initiation of INTerpath-002, a pivotal Phase 3 randomized clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant treatment in patients with completely resected (R0) Stage II, IIIA or IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC). Global recruitment of the INTerpath-002 has begun, and the first patients enrolled in Australia.
Dec 11, 2023 06:45 am ET
Merck Animal Health Receives Positive CVMP Opinion for an Injectable Formulation of BRAVECTO® (Fluralaner) for Use in Dogs
Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) issued a positive opinion for BRAVECTO® (fluralaner) 150 mg/ml powder and solvent for suspension for injection for dogs. The CVMP recommends the product for approval for the treatment and persistent killing of fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Rhipicephalus sang
Dec 08, 2023 06:45 am ET
Merck and Eisai Provide Update on Phase 3 LEAP-001 Trial Evaluating (pembrolizumab) Plus LENVIMA® (lenvatinib) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced that the Phase 3 LEAP-001 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
Dec 07, 2023 06:45 am ET
Merck Announces KEYLYNK-008 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LYNPARZA® (olaparib) for Patients With Metastatic Squamous Non-Small Cell Lung Cancer to Stop for Futility
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that it will stop the Phase 3 KEYLYNK-008 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). Merck is discontinuing the study based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis (IA3). At the interim analysis 3, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plu
Dec 07, 2023 06:00 am ET
Merck Announces Findings from Phase 2 KeyVibe-002 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab in Previously Treated Patients with Metastatic Non-Small Cell Lung
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced full results from the non-registrational Phase 2 KeyVibe-002 trial evaluating vibostolimab/pembrolizumab, an investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, with or without docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progressive disease after treatment with immunotherapy and platinum-doublet chemotherapy. These results are being presented today during a poster sess
Nov 30, 2023 05:00 pm ET
FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urot
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency
Nov 29, 2023 09:00 am ET
AWS and Accenture Help Merck Use Cloud Technology to Reduce Drug Discovery Time and Accelerate Clinical Trial Development
At AWS re:Invent, Amazon Web Services, Inc. (AWS), an Amazon.com, Inc. company (NASDAQ: AMZN), today announced it is working with Accenture (NYSE: ACN) to help Merck (NYSE: MRK), known as MSD outside of the U.S. and Canada, to move a substantial portion of its IT infrastructure to AWS as part of the company’s multiyear cloud migration.
Nov 28, 2023 01:17 pm ET
Merck Announces First-Quarter 2024 Dividend
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Board of Directors has declared a quarterly dividend of $0.77 per share of the company’s common stock for the first quarter of 2024. Payment will be made on Jan. 8, 2024, to shareholders of record at the close of business on Dec. 15, 2023.
Nov 28, 2023 06:45 am ET
Merck’s V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults, Demonstrated Superior Immunogenicity for 10 of 11 Unique Serotypes Compared to PCV20
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from STRIDE-3, a Phase 3 trial evaluating V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to protect adults. The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine.
Nov 21, 2023 06:45 am ET
Merck to Acquire Caraway Therapeutics, Inc.
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Caraway Therapeutics, Inc. announced today that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Caraway Therapeutics for a total potential consideration of up to $610 million, including an undisclosed upfront payment as well as contingent milestone payments. The upfront payment will be expensed by Merck in the fourth quarter of 2023 and included in non-GAAP results.
Nov 20, 2023 06:45 am ET
Merck to Participate in the 6th Annual Evercore ISI HealthCONx Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, is scheduled to participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on Thursday, Nov. 30, 2023, at 1:20 p.m. ET.
Nov 16, 2023 05:40 pm ET
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenoc
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Nov 10, 2023 07:40 am ET
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as First-Line Treatment for Locally Advanced Unresectable or Metastatic Biliary Tract Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma.
Nov 08, 2023 06:45 am ET
Merck to Participate in the Jefferies London Healthcare Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Caroline Litchfield, executive vice president and chief financial officer, is scheduled to participate in a fireside chat at the Jefferies London Healthcare Conference on Thursday, Nov. 16, 2023, at 5:00 a.m. ET / 10:00 a.m. GMT.
Nov 01, 2023 06:50 am ET
Merck to Participate in the UBS BioPharma Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Jannie Oosthuizen, president, Human Health U.S., is scheduled to participate in a fireside chat at the UBS BioPharma Conference on Wednesday. Nov. 8, 2023, at 12:00 p.m. EST.
Nov 01, 2023 06:45 am ET
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). The approval was based on results from the Phase 3 KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in the study’s primary endpoint of overall survival (OS), reducing the risk of death by 17% (HR=0.8
Nov 01, 2023 06:30 am ET
KEYTRUDA® (pembrolizumab) Significantly Improved Overall Survival (OS) Versus Placebo as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Nephrectomy
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met its key secondary endpoint of overall survival (OS), for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, KEYTRUDA demonstrated a statistically significant and clinically mean
Oct 26, 2023 06:30 am ET
Merck Announces Third-Quarter 2023 Financial Results
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2023.
Oct 25, 2023 07:30 am ET
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) is Available for the First-Line Treatment of Adult Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC)
KIRKLAND, QC, and MISSISSAUGA, ON, Oct. 25, 2023 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai announced today that KEYTRUDA®, an anti-PD-1 therapy, in combination with LENVIMA®, the multiple receptor tyrosine kinase inhibitor discovered by Eisai, is reimbursed under the Alberta, British Columbia, Nova Scotia, Ontario, Quebec, and Saskatchewan drug plans with respective clinical criteria and conditions for adult patients with advanced (not amenable to curative surgery or radiation) or metastatic renal cell carcinoma (RCC), with no prior systemic ther
Oct 24, 2023 08:00 am ET
Merck Senior Vice President Sarah Aiosa Named to Most Powerful Latinas List
NORTHAMPTON, MA / ACCESSWIRE / October 24, 2023 / We're proud to celebrate Sarah M. Aiosa, SVP and president, Latin America, for being recognized as one of The Association of Latino Professionals for Americas' 2023 Most Powerful Latinas! Sarah was highlighted among the most influential trailblazers in business, entrepreneurship and civic engagement who are empowering and encouraging the next generation of Latina leaders to reach their full potential. Congrats to all of this year's nominees.
Oct 22, 2023 10:30 am ET
KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Reduced Risk of Death by More Than Half Versus Chemotherapy in Patients With Previously Untreated Locally Advanced or Metastatic Urothe
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 KEYNOTE-A39 trial (also known as EV-302), which was conducted in collaboration with Seagen and Astellas, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, compared to chemotherapy (gemcitabine plus cisplatin or carboplatin) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).
Oct 21, 2023 08:45 am ET
Merck’s WELIREG® (belzutifan) Significantly Improved Progression-Free Survival and Objective Response Rates Versus Everolimus in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 LITESPARK-005 trial investigating WELIREG, Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) that progressed following PD-1/L1 and vascular endothelial growth factor receptor (VEGFR) targeted therapies. In the study, WELIREG demonstrated a statistically significant improvement in one of the trial’s dual primary endpoints of progression-free survival (PFS) and in a key second
Oct 20, 2023 10:00 am ET
Merck’s KEYTRUDA® (pembrolizumab) Plus Concurrent Chemoradiotherapy Significantly Improved Progression-Free Survival (PFS) Versus Concurrent Chemoradiotherapy Alone in Newly Diagnosed, High-Risk Local
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the pivotal Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) for newly diagnosed patients with high-risk locally advanced cervical cancer (stage 1B2-2B with lymph node-positive disease, and stage 3-4A with and without lymph node-positive disease). Results from the trial showed t
Oct 20, 2023 08:02 am ET
Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Showed Statistically Significant Improvement in Pathological Complete Response (pCR) Rate as Neoadjuvant Therapy Versus Chemotherapy in High-Risk, E
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of results from the neoadjuvant part of the Phase 3 KEYNOTE-756 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, followed by KEYTRUDA plus endocrine therapy as adjuvant treatment, for patients with high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. KEYTRUDA plus chemotherapy before surgery met one of its dual primary endpoints of pathological
Oct 20, 2023 08:01 am ET
KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy Significantly Improved Progression-Free Survival (PFS) Versus Trastuzumab and Chemotherapy in First-Line HER2-Positive Advanced Gastric or G
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. These data are being presented today during a proffered paper session at the European Society for Medical Oncology (ESMO) Con
Oct 20, 2023 08:00 am ET
KEYTRUDA® (pembrolizumab) Plus Chemotherapy Before Surgery and Continued as Single Agent After Surgery Reduced Risk of Death by 28% Versus Pre-Operative Chemotherapy in Resectable Stage II, IIIA or II
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 KEYNOTE-671 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen, which includes treatment before surgery (neoadjuvant) and after surgery (adjuvant), for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). These late-breaking data are being presented for the first time today during a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2023 (abstract #LBA56).
Oct 19, 2023 07:30 pm ET
Daiichi Sankyo and Merck Announce Global Development and Commercialization Collaboration for Three Daiichi Sankyo DXd ADCs
Daiichi Sankyo (TSE: 4568) and Merck (known as MSD outside of the United States and Canada) (NYSE: MRK) have entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd antibody drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd). The companies will jointly develop and potentially commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.
Oct 17, 2023 06:45 am ET
Merck Receives Positive EU CHMP Opinion for PREVYMIS® for Prevention of CMV Disease in High-Risk Adult Kidney Transplant Recipients and Extended 200-Day Dosing in Adult HSCT Recipients at Risk for Lat
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of PREVYMIS® (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]). The CHMP has also recommended the approval for extending dosing for PREVYMIS from 100 days to 200 days following transplant in adult CMV-seropositive recipients [R+] of an all
Oct 16, 2023 07:00 pm ET
FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With Resectable (T≥4 cm or N+) NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as a Single Agent as Adj
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of patients with resectable (tumors ≥4 centimeters [cm] or node positive) non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. With this approval, KEYTRUDA has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.
Oct 16, 2023 06:45 am ET
European Commission Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adults With Non-Small Cell Lung Cancer at High Risk of Recurrence Following Complete Resection and Platinum-Based Chemo
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
Oct 13, 2023 07:45 am ET
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for HER2-Negative Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Exp
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1).
Oct 10, 2023 06:45 am ET
Merck Highlights Innovative Oncology Portfolio and Pipeline at ESMO Congress 2023 Underscoring Commitment to Advancing Cancer Research and Improving Patient Outcomes Across Multiple Stages of Disease
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new data for four approved medicines and three pipeline candidates in more than 15 types of cancer will be presented at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, from Oct. 20-24. Presentations will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA, Merck’s anti-PD-1 therapy; WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor; LENVIMA® (lenvatinib), in collaboration with Eisai; and LYNPARZA
Oct 10, 2023 06:30 am ET
Merck Announces Pivotal KEYNOTE-671 Trial Meets Dual Primary Endpoint of Overall Survival (OS) in Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer (NSCLC)
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the Phase 3 KEYNOTE-671 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) met its dual primary endpoint of overall survival (OS). At a pre-specified interim analysis, KEYTRUDA plus chemotherapy before surgery (neoadjuvant), followed by resection and KEYTRUDA as a single agent after surgery (adjuvant), demonstrated a statistically significant and clinically meaningful i
Oct 05, 2023 08:15 am ET
Merck is Collaborating to Address Antimicrobial Resistance
Shared commitments like the AMR Action Fund are vital to make progress against this public health threat
Oct 05, 2023 07:00 am ET
Merck’s KEYTRUDA® (pembrolizumab) Met Primary Endpoint of Disease-Free Survival (DFS) in Certain Patients With Muscle-Invasive Urothelial Carcinoma (MIUC) After Surgery
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 AMBASSADOR (A031501) trial (KEYNOTE-123) evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met one of its dual primary endpoints of disease-free survival (DFS) for the adjuvant treatment of patients with localized muscle-invasive urothelial carcinoma (MIUC) and locally advanced urothelial carcinoma versus observation. At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, KEYTRUDA demonstrated a statistically significant and clinically meaningful im
Oct 05, 2023 06:45 am ET
Merck to Hold Third-Quarter 2023 Sales and Earnings Conference Call Oct. 26
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its third-quarter 2023 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Thursday, Oct. 26. During the call, company executives will provide an overview of Merck’s performance for the quarter.
Oct 03, 2023 10:00 am ET
Merck Helps To Improve Diversity in Clinical Trials Through Beacon of Hope
NORTHAMPTON, MA / ACCESSWIRE / October 3, 2023 / Merck & Co., Inc.
Sep 28, 2023 06:45 am ET
Merck Receives Priority Review from FDA for New Biologics License Application for Sotatercept, an Activin Signaling Inhibitor to Treat Adults with Pulmonary Arterial Hypertension (PAH)
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for sotatercept, Merck’s novel investigational activin signaling inhibitor, for the treatment of adult patients with pulmonary arterial hypertension (PAH) (WHO Group 1). The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of March 26, 2024.
Sep 22, 2023 06:45 am ET
Merck and Eisai Provide Update on Two Phase 3 Trials Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Patients With Certain Types of Metastatic Non-Small Cell Lung Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today provided updates on two Phase 3 trials, LEAP-006 and LEAP-008, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, in patients with certain types of metastatic non-small cell lung cancer.
Sep 22, 2023 06:00 am ET
Merck Announces Phase 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Previously Untreated Locally Advanced
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 KEYNOTE-A39 trial (also known as EV-302), which was conducted in collaboration with Seagen and Astellas, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) versus chemotherapy (gemcitabine plus cisplatin or carboplatin) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). The trial enrolled patients who may or may not be eligible for treatment with cisplatin-based chemo
Sep 20, 2023 06:45 am ET
FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Concurrent Chemoradiotherapy as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Can
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed patients with high-risk locally advanced cervical cancer. The sBLA is based on data from the KEYNOTE-A18 tria
Sep 19, 2023 06:45 am ET
FDA Accepts for Priority Review Merck’s Supplemental New Drug Application for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental new drug application (sNDA) seeking approval for WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following immune checkpoint and anti-angiogenic therapies. The sNDA is based on data from the LITESPARK-005 trial, in which WELIREG demonstrated a statistically significant and clinically meaningful improve
Sep 15, 2023 09:10 am ET
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adults with Non-Small Cell Lung Cancer at High Risk of Recurrence Following Complete Resection and Plati
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC), who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
Sep 11, 2023 07:45 am ET
Merck Presents New Analyses Supporting the Promising Potential of Sotatercept, its Investigational Medicine for Adults with Pulmonary Arterial Hypertension (PAH)
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new analyses from studies of sotatercept, Merck’s novel investigational activin signaling inhibitor biologic, for adults with pulmonary arterial hypertension (PAH) (WHO Group 1) at the European Respiratory Society (ERS) International Congress 2023. A new exploratory post-hoc analysis of right heart catheterization and echocardiography data from patients in the Phase 3 STELLAR study showed treatment with sotatercept for 24 weeks on top of background therapy reduced right heart size and improved right-ventri
Sep 07, 2023 06:45 am ET
European Commission Expands Merck’s ERVEBO® [Ebola Zaire Vaccine, (rVSVΔG-ZEBOV-GP) live] Indication to Include Children 1 Year of Age and Older
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved an expanded indication for ERVEBO for active immunization of individuals 1 year of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire ebolavirus. The EC’s decision follows the positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) received on July 20, 2023. The vaccine was
Sep 05, 2023 08:00 am ET
Long-Term Follow-up Data on Sustained Immunogenicity and Safety for GARDASIL®9 Published in Pediatrics
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced new, 10-year long-term follow-up (LTFU) data published in the peer reviewed journal, Pediatrics, for girls and boys who received a three-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at 9-15 years old. The LTFU study was conducted from 2009 through 2021 across 13 countries and five continents.
Sep 05, 2023 06:45 am ET
Merck to Participate in the Morgan Stanley 21st Annual Global Healthcare Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Caroline Litchfield, executive vice president and chief financial officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Morgan Stanley 21st Annual Global Healthcare Conference on Monday, Sept. 11, 2023, at 2:15 p.m. EDT.
Aug 29, 2023 06:50 am ET
European Commission Approves KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy as First-Line Treatment for HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Ex
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1).
Aug 29, 2023 06:45 am ET
Merck to Participate in the Citi 18th Annual BioPharma Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Dr. Marjorie C. Green, senior vice president and head of late-stage oncology, Global Clinical Development, is scheduled to participate in a fireside chat at the Citi 18th Annual BioPharma Conference on Wednesday, Sept. 6, 2023, at 1:50 p.m. EDT.
Aug 25, 2023 06:30 am ET
Merck Initiates Phase 3 Clinical Program for Oral PCSK9 Inhibitor Candidate MK-0616
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the company’s Phase 3 clinical program, CORALreef, for MK-0616, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, being evaluated for the treatment of adults with hypercholesterolemia. This is the first Phase 3 clinical program for an oral PCSK9 inhibitor. The first participants are now enrolling in two registrational Phase 3 studies evaluating low-density lipoprotein (LDL) cholesterol reduction: CORALreef Lipids and CORALreef HeFH. Merck also plans
Aug 25, 2023 06:15 am ET
Merck and Eisai Provide Update on Phase 3 LEAP-010 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Patients With Certain Types of Recurrent or Metastatic Head and Neck Squamou
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today provided an update on the Phase 3 LEAP-010 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. The primary endpoints of the study were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).
Aug 24, 2023 06:45 am ET
LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone Approved in Japan for the Treatment of BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) has been approved in Japan for the treatment of adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC).
Aug 18, 2023 06:45 am ET
Merck Announces WELIREG® (belzutifan) Phase 3 LITESPARK-005 Trial Met Primary Endpoint of Progression-Free Survival in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from LITESPARK-005, the first positive Phase 3 trial investigating WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. LITESPARK-005 is evaluating WELIREG for the treatment of adult patients with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies. In the trial, WELIREG showed a statistically significant and clinically meaningful improvement
Aug 16, 2023 08:00 am ET
Merck Employee Talks Pride, Pediatrics and Parenting
NORTHAMPTON, MA / ACCESSWIRE / August 16, 2023 / Merck & Co., Inc.
Aug 08, 2023 08:15 am ET
Merck Is Harnessing Innovation To Reach Indigenous Communities
NORTHAMPTON, MA / ACCESSWIRE / August 8, 2023 / Merck & Co., Inc. - Alaska is a vast state with extremes in weather and terrain. For people living in its 240 remote villages and communities, obtaining lifesaving medicines can be a challenge. And extreme challenges call for innovative solutions.
Aug 03, 2023 06:45 am ET
U.S. FDA Approves Merck’s ERVEBO® (Ebola Zaire Vaccine, Live) for Use in Children 12 Months of Age and Older
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for ERVEBO, which is now indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older. The vaccine was
Aug 01, 2023 06:30 am ET
Merck Announces Second-Quarter 2023 Financial Results
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2023.
Jul 28, 2023 06:45 am ET
Merck Announces Phase 3 KEYNOTE-756 Trial Met Primary Endpoint of Pathological Complete Response (pCR) Rate in Patients With High-Risk, Early-Stage ER+/HER2- Breast Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-756 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of pathological complete response (pCR) rate following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. At a prespecified interim analysis conducted by an independent Data Monitoring Comm
Jul 27, 2023 06:45 am ET
Merck Announces V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Met Key Immunogenicity and Safety Endpoints in Two Phase 3 Trials
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from two Phase 3 trials evaluating V116, the company’s investigational 21-valent pneumococcal conjugate vaccine in vaccine-naïve and previously vaccinated individuals. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults. Results from the STRIDE-3 trial demonstrated statistically significant immune responses compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults for serotypes common to both vaccines as as
Jul 26, 2023 06:45 am ET
Merck and Moderna Initiate Phase 3 Study Evaluating V940 (mRNA-4157) in Combination with KEYTRUDA® (pembrolizumab) for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the initiation of the pivotal Phase 3 randomized V940-001 clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma. Global recruitment in V940-001 has begun, and the first patients are now enrolling in Aus
Jul 25, 2023 12:58 pm ET
Merck Announces Fourth-Quarter 2023 Dividend
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Board of Directors has declared a quarterly dividend of $0.73 per share of the company’s common stock for the fourth quarter of 2023. Payment will be made on Oct. 6, 2023, to shareholders of record at the close of business on Sept. 15, 2023.
Jul 25, 2023 08:10 am ET
Merck is Safeguarding the Environment Through Green Chemistry
NORTHAMPTON, MA / ACCESSWIRE / July 25, 2023 / Merck & Co., Inc.
Jul 21, 2023 07:52 am ET
Merck Receives Positive European Union CHMP Opinion for Gefapixant
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, developed for the treatment for adults with refractory or unexplained chronic cough. The CHMP’s recommendation will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU) and a final decision is expected later this year.
Jul 21, 2023 07:50 am ET
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy as First-Line Treatment for HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Ad
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Posi
Jul 19, 2023 06:45 am ET
Merck Announces Phase 3 KEYNOTE-A18 Trial Met Primary Endpoint of Progression-Free Survival (PFS) in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) met one of its primary endpoints of progression-free survival (PFS) as treatment for newly diagnosed patients with high-risk locally advanced cervical cancer. At a prespecified interim analysis conducted by an independent Data Monitor
Jul 17, 2023 03:55 pm ET
3 Ways Merck Supports the LGBTQ+ Community
NORTHAMPTON, MA / ACCESSWIRE / July 17, 2023 / At Merck, our commitment to equality goes beyond the month of June.
Jun 29, 2023 06:45 am ET
Merck to Hold Second-Quarter 2023 Sales and Earnings Conference Call on Aug. 1
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its second-quarter 2023 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. ET on Tuesday, Aug. 1. During the call, company executives will provide an overview of Merck’s performance for the quarter.
Jun 20, 2023 06:45 am ET
Merck Provides Update on Phase 3 KEYNOTE-585 Trial in Locally Advanced Resectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from the Phase 3 KEYNOTE-585 trial, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, followed by adjuvant treatment with KEYTRUDA plus chemotherapy, then KEYTRUDA monotherapy in patients with locally advanced resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma. At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, the study met one of its primary endpoints of pathological comp
Jun 16, 2023 04:04 pm ET
Merck Completes Acquisition of Prometheus Biosciences, Inc.
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the Prometheus Biosciences, Inc. (“Prometheus”) (NASDAQ: RXDX) acquisition. Prometheus is now a wholly-owned subsidiary of Merck and the common stock of Prometheus will no longer be listed or traded on the Nasdaq Global Market.
Jun 16, 2023 11:45 am ET
Merck is Collaborating To Help Make Cancer Care More Accessible Worldwide
NORTHAMPTON, MA / ACCESSWIRE / June 16, 2023 / Merck & Co., Inc.
Jun 16, 2023 06:45 am ET
KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy Met Primary Endpoint of Progression-Free Survival as First-Line Treatment in Patients With HER2-Positive Advanced Gastric or Gastroesophagea
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-811 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab and chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with trastuzumab and chemothera
Jun 13, 2023 04:05 pm ET
U.S. District Court for the District of New Jersey Rules in Favor of Merck in Patent Infringement Lawsuit Related to BRIDION® (sugammadex)
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. District Court for the District of New Jersey ruled in favor of the company and found that Merck correctly calculated the Patent Term Extension period for the primary patent related to BRIDION® (sugammadex). Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.
Jun 12, 2023 06:45 am ET
Merck to Present Data for Efinopegdutide (MK-6024), an Investigational GLP-1/Glucagon Receptor Co-agonist, in Patients with Nonalcoholic Fatty Liver Disease (NAFLD) at EASL 2023
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that new findings for efinopegdutide (MK-6024), an investigational GLP-1/glucagon receptor co-agonist, have been accepted for oral presentation at the European Association for the Study of the Liver (EASL) Annual Congress from June 21-24. Data to be shared include results from the Phase 2a clinical trial evaluating efinopegdutide in adult patients with nonalcoholic fatty liver disease (NAFLD).
Jun 08, 2023 06:45 am ET
FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Advanced or Unresectable Biliary Tract Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). The sBLA is based on data from the KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement i
Jun 06, 2023 06:50 am ET
U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved a new indication for PREVYMIS® (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]) following a priority review.
Jun 06, 2023 06:45 am ET
Merck to Participate in the Goldman Sachs 44th Annual Global Healthcare Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Caroline Litchfield, executive vice president and chief financial officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Goldman Sachs 44th Annual Global Healthcare Conference on Monday, June 12, 2023, at 4:00 p.m. PDT / 7:00 p.m. EDT.
Jun 05, 2023 08:00 am ET
Moderna and Merck Announce mRNA-4157 (V940) in Combination With KEYTRUDA(R) (pembrolizumab) Demonstrated a Statistically Significant and Clinically Meaningful Improvement in Distant Metastasis-Free Su
mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of distant metastasis or death by 65% (HR=0.347 [95% CI, 0.145-0.828]); one-sided p value=0.0063) compared to KEYTRUDA alone
Jun 03, 2023 09:00 am ET
Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Before Surgery and Continued as a Single Agent After Surgery Reduced the Risk of Event-Free Survival Events by 42% Versus Pre-Operative Chemotherapy
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive results from the pivotal Phase 3 KEYNOTE-671 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen, which includes treatment before surgery (neoadjuvant) and after surgery (adjuvant), for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). After a median follow-up of 25.2 months, neoadjuvant KEYTRUDA plus chemotherapy followed by resection and adjuvant single-agent KEYTRUDA significantly improved EFS, reducing the risk of disease
Jun 03, 2023 08:00 am ET
KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy Alone as First-Line Treatment for Unresectable Advanced Pleural Mesothelioma
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and the Canadian Cancer Trials Group (CCTG) today announced results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus chemotherapy as first-line treatment for patients with unresectable advanced pleural mesothelioma. At the final analysis of the study, KEYTRUDA plus chemotherapy significantly improved overall survival (OS), reducing the risk of death by 21% (HR=0.79 [95% CI, 0.64-0.98]; two-sided p value=0.0324), with a median OS of 17.3 months (95% CI, 14.4-21.3) versus
Jun 01, 2023 06:45 am ET
FDA Approves LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
May 25, 2023 05:00 pm ET
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced data from the final pre-specified overall survival (OS) analysis of the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). These data will be presented on Monday, June 5 at 12:54 p.m. EDT during an oral abstract session at the 2023 American Society of Clinical Oncol
May 23, 2023 02:45 pm ET
Merck Announces Third-Quarter 2023 Dividend
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Board of Directors has declared a quarterly dividend of $0.73 per share of the company’s common stock for the third quarter of 2023. Payment will be made on July 10, 2023, to shareholders of record at the close of business on June 15, 2023.
May 15, 2023 06:45 am ET
Merck to Present Extensive New Research Demonstrating Significant Progress in the Treatment of Certain Earlier Stage Cancers and in Advancing Broad Oncology Pipeline at 2023 ASCO Annual Meeting
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that data for four approved medicines and two pipeline candidates in more than 25 types of cancer will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2-6. Presentations will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA, Merck’s anti-PD-1 therapy; LENVIMA; LYNPARZA® (olaparib), in collaboration with AstraZeneca; and WELIREG™ (belzutifan). Additionally, Merck will present data from its broad pi
May 08, 2023 02:45 pm ET
Merck Announces Global Grants Program To Improve Access to Quality Health Care in Underserved Communities
RAHWAY, NJ / ACCESSWIRE / May 8, 2023 / To support the work of nonprofits dedicated to improving the well-being of underserved populations in communities around the world, Merck (NYSE:MRK), known as MSD outside of the United States and Canada, has announced a new global grants program, Solutions for Healthy Communities (SHC).
May 03, 2023 03:00 pm ET
Merck: Supporting Colleagues Working With Cancer
NORTHAMPTON, MA / ACCESSWIRE / May 3, 2023 / Merck & Co., Inc.
May 03, 2023 06:45 am ET
Merck to Participate in Bank of America Securities 2023 Healthcare Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Caroline Litchfield, executive vice president and chief financial officer, is scheduled to participate in a fireside chat at the Bank of America Securities 2023 Healthcare Conference on Wednesday, May 10, 2023, at 8:40 a.m. PDT / 11:40 a.m. EDT.
May 01, 2023 12:56 pm ET
BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Spectrum Pharmaceuticals, Inc. (Nasdaq – SPPI), BELLUS Health Inc (Nasdaq – BLU), Prometheus Biosciences, Inc.
Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky ([email protected]) or Marc Ackerman ([email protected]) at 855-576-4847. There is no...
Apr 28, 2023 05:30 pm ET
Update on FDA Advisory Committee Vote on LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients, recommending against app
Apr 27, 2023 09:31 am ET
Thinking about buying stock in Merck, Enphase Energy, Tilray, Canopy Growth, or Hasbro?
NEW YORK, April 27, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for MRK, ENPH, TLRY, CGC, and HAS.
Apr 27, 2023 06:30 am ET
Merck Announces First-Quarter 2023 Financial Results
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2023.
Apr 25, 2023 12:46 pm ET
BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Spectrum Pharmaceuticals, Inc. (Nasdaq – SPPI), BELLUS Health Inc (Nasdaq – BLU), Prometheus Biosciences, Inc.
Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky ([email protected]) or Marc Ackerman ([email protected]) at 855-576-4847. There is no...
Apr 21, 2023 02:29 pm ET
Thinking about trading options or stock in Humana, Spotify, Mastercard, Altria Group, or Merck?
NEW YORK, April 21, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for HUM, SPOT, MA, MO, and MRK.
Apr 18, 2023 10:06 am ET
BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: BELLUS Health Inc (Nasdaq – BLU), Prometheus Biosciences, Inc. (Nasdaq – RXDX), Univar Solutions Inc. (NYSE - U
Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky ([email protected]) or Marc Ackerman ([email protected]) at 855-576-4847. There is no...
Apr 16, 2023 11:00 am ET
Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Compared to Chemotherapy Alone in Patients With Advanced or Unresectable Biliary Tract Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 KEYNOTE-966 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the first-line treatment of patients with advanced or unresectable biliary tract cancer (BTC). Results from the trial showed the KEYTRUDA regimen demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to chemotherapy alone for these patients. These data are being presented dur
Apr 16, 2023 11:00 am ET
Moderna and Merck Announce mRNA-4157 (V940), an Investigational Individualized Neoantigen Therapy, in Combination with KEYTRUDA(R) (Pembrolizumab), Demonstrated Superior Recurrence-Free Survival in Pa
mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone in stage III/IV melanoma patients with high risk of recurrence following complete resection
Apr 16, 2023 06:00 am ET
Merck Strengthens Immunology Pipeline with Acquisition of Prometheus Biosciences, Inc.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Prometheus Biosciences, Inc. (“Prometheus”) (Nasdaq: RXDX) today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, has agreed to acquire Prometheus for $200.00 per share in cash for a total equity value of approximately $10.8 billion.
Apr 16, 2023 06:00 am ET
Merck Strengthens Immunology Pipeline with Acquisition of Prometheus Biosciences, Inc.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Prometheus Biosciences, Inc. (“Prometheus”) (Nasdaq: RXDX) today announced that the companies have entered into a definitive agreement under which Merck, through a...
Apr 13, 2023 06:45 am ET
FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcin
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The sBLA is based on data from the KEYNOTE-859 trial, in which KEYTRUDA plus chemotherapy demonstrated a
Apr 11, 2023 01:20 pm ET
Merck Named One of Fortune’s 2023 100 Best Companies to Work For(R)
RAHWAY, NJ / ACCESSWIRE / April 11, 2023 / Merck (NYSE:MRK), known as MSD outside of the United States and Canada, has earned a place on the Fortune 100 Best Companies to Work For list for the second time in the past three years. The company also made the list in 2021.
Apr 07, 2023 06:45 am ET
Merck and Eisai Provide Update on Phase 3 Trials of KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) In Certain Patients With Advanced Melanoma (LEAP-003) and Metastatic Colorectal Cancer (LEAP-01
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today provided updates on two Phase 3 trials, LEAP-003 and LEAP-017 investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.
Apr 06, 2023 05:00 pm ET
MRNA-4157/V940, an Investigational Personalized MRNA Cancer Vaccine, in Combination With Keytruda(R) (Pembrolizumab), Receives Prime Scheme Designation From the European Medicines Agency for Adjuvant
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial and unmet need for additional therapeutic options for certain types of melanoma
Apr 06, 2023 02:15 pm ET
Merck: Aiming for Health Equity and Business Success
NORTHAMPTON, MA / ACCESSWIRE / April 6, 2023 / Josette Gbemudu is motivated to ensure everyone has the chance to be as healthy as possible.
Apr 04, 2023 01:10 pm ET
Merck Ranked No. 1 in the Pharmaceutical Industry Among Barron’s 100 Most Sustainable U.S. Companies 2023
RAHWAY, NJ / ACCESSWIRE / April 4, 2023 / Merck, known as MSD outside of the United States and Canada, has been named one of Barron's 100 Most Sustainable U.S. Companies for the third consecutive year, ranking No. 1 in the pharmaceutical industry and advancing 38 spots in the overall rankings from last year-from No. 67 overall in 2022 to No. 29 overall in 2023.
Apr 03, 2023 05:00 pm ET
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description
Mar 30, 2023 09:31 am ET
Thinking about buying stock in Humana, Spotify, Mastercard, Altria Group, or Merck?
NEW YORK, March 30, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for HUM, SPOT, MA, MO, and MRK.
Mar 30, 2023 06:45 am ET
Merck to Hold First-Quarter 2023 Sales and Earnings Conference Call on April 27
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its first-quarter 2023 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Thursday, April 27. During the call, company executives will provide an overview of Merck’s performance for the quarter.
Mar 29, 2023 04:15 pm ET
FDA Converts to Full Approval Indication for KEYTRUDA® (pembrolizumab) for Certain Adult and Pediatric Patients With Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The conversion from an accelerated to a full (regular) approval is based on re
Mar 27, 2023 05:15 pm ET
KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Progression-Free Survival Compared to Chemotherapy Alone as First-Line Therapy for Advanced or Recurrent Endometrial Carcinoma, Regar
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 NRG‑GY018 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel) then continued as a single agent every six weeks for up to 14 cycles for the first-line treatment of patients with stage III-IV or recurrent endometrial carcinoma whose cancer was either mismatch repair proficient (pMMR) or mismatch repair deficient (dMMR). Results from the trial showed the KEYTRUDA regimen demonstrated a statistically si
Mar 22, 2023 03:45 pm ET
Amplifying the Power of Women in Chemistry
NORTHAMPTON, MA / ACCESSWIRE / March 22, 2023 / Merck & Co., Inc.
Mar 16, 2023 04:05 pm ET
Merck Provides Update from Open-Label Arm of Phase 2 KeyVibe-002 Trial Evaluating MK-7684A, a Coformulation of Vibostolimab and Pembrolizumab, in Previously Treated Patients with Metastatic Non-Small
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided an update on the open-label arm of the non-registrational Phase 2 KeyVibe-002 trial. KeyVibe-002 is evaluating MK-7684A, a coformulation of vibostolimab, an anti-TIGIT therapy, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, with or without docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progressive disease after treatment with immunotherapy and platinum-doublet chemotherapy. KeyVibe-002, a partially blinded study, was designed with two pr
Mar 10, 2023 06:45 am ET
KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy Alone as First-Line Treatment for Advanced Malignant Pleural Mesothelioma
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and the Canadian Cancer Trials Group (CCTG) today announced that the Phase 2/3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met its primary endpoint of overall survival (OS) for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. IND.227 was sponsored by CCTG, in collaboration with investigators in Italy (co-sponsored by National Cancer Institute of Naples - NCIN), and France (co-sponsored by The Fr
Mar 08, 2023 06:45 am ET
Merck to Present at the Barclays 2023 Global Healthcare Conference
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Jannie Oosthuizen, president, Human Health U.S., is scheduled to participate in a fireside chat at the Barclays 2023 Global Healthcare Conference on Wednesday, March 15, 2023, at 2:35 p.m. ET.
Mar 06, 2023 12:01 pm ET
Merck’s Investigational Activin Signaling Inhibitor Sotatercept Improved Six-Minute Walk Distance by 40.8 Meters at Week 24 Versus Placebo in Adults with Pulmonary Arterial Hypertension on Background
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced full results from the Phase 3 STELLAR trial, which evaluated sotatercept, Merck’s novel investigational activin signaling inhibitor biologic, in combination with stable background therapy for the treatment of adult patients with pulmonary arterial hypertension (PAH) (WHO Group 1). Sotatercept significantly improved exercise capacity, increasing 6-minute walk distance (6MWD) by 40.8 meters (95% CI, 27.5-54.1; p
Mar 06, 2023 12:00 pm ET
Merck’s MK-0616, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Patients with Hypercholesterolemia in Phase 2b Study
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 2b clinical trial evaluating MK-0616, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in adults with hypercholesterolemia. The primary objective of the study was to evaluate the percent change in low density lipoprotein cholesterol (LDL-C) from baseline to week 8 for 4 doses of MK-0616 (6, 12, 18 and 30 mg) versus placebo. At week 8, all doses of MK-0616 significantly reduced LDL-C compared to placebo and the placebo-adjusted reduct
Mar 06, 2023 06:45 am ET
US FDA Approves Intramuscular Administration for Merck’s MMRV Family of Vaccines: M-M-RII (Measles, Mumps, and Rubella Virus Vaccine Live), VARIVAX (Varicella Virus Vaccine Live), and ProQuad (Measles
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved the addition of the intramuscular (IM) route of administration to the United States Product Insert (USPI) for Merck’s MMRV family of vaccines: M-M-R®II, VARIVAX®, and ProQuad®.
Mar 02, 2023 09:00 am ET
Merck and AstraZeneca Provide Update on US Regulatory Review of LYNPARZA® (olaparib) for Use in Combination With Abiraterone and Prednisone or Prednisolone for the Treatment of Metastatic Castration-R
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for use of LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for us
Mar 01, 2023 06:45 am ET
Merck Announces Phase 3 KEYNOTE-671 Trial Met Primary Endpoint of Event-Free Survival (EFS) in Patients With Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Phase 3 KEYNOTE-671 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, met one of its dual primary endpoints, event-free survival (EFS), as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). A perioperative treatment regimen includes treatment before surgery (neoadjuvant) and continued after surgery (adjuvant). The trial will continue to evaluate the other dual primary endpoint of overall survival (OS).
Feb 28, 2023 06:45 am ET
Merck Provides Update on Phase 3 Trials KEYNOTE-641 and KEYNOTE-789
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided updates on two Phase 3 trials, KEYNOTE-641 and KEYNOTE-789. Merck is discontinuing the Phase 3 KEYNOTE-641 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) based on the recommendation of an independent Data Monitoring Committee. At an interim analysis, KEYTRUDA in combination with enzalutamide and ADT did not demon
Feb 24, 2023 06:49 am ET
Merck and Ridgeback Provide Update on EU Marketing Authorization Application for LAGEVRIO™ (Molnupiravir)
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the refusal of the marketing authorization for LAGEVRIO™ (molnupiravir) for the treatment of certain adults who have been diagnosed with COVID-19 in the European Union (EU). Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
Feb 22, 2023 04:05 pm ET
Moderna and Merck Announce mRNA-4157/V940, an Investigational Personalized mRNA Cancer Vaccine, in Combination With KEYTRUDA(R) (pembrolizumab), was Granted Breakthrough Therapy Designation by the FDA
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
Feb 22, 2023 06:45 am ET
Merck Opens Enrollment in New Phase 3 Clinical Trials with Investigational Once-Daily Islatravir in Combination with Doravirine for Treatment of HIV-1 Infection
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the company has opened enrollment in its new Phase 3 clinical program with investigational once-daily islatravir 0.25 mg in combination with doravirine 100 mg (DOR/ISL) for the treatment of HIV-1 infection.
Feb 21, 2023 06:45 am ET
Merck to Present New Data for Sotatercept and MK-0616 at ACC.23/WCC, Demonstrating Significant Progress in Advancing Its Innovative Cardiovascular Pipeline
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of clinical data from its broad and advancing cardiovascular pipeline and portfolio at the upcoming American College of Cardiology’s 72nd Annual Scientific Session together with World Heart Federation’s World Congress of Cardiology (ACC.23/WCC) in New Orleans, LA from March 4-6, 2023.
Feb 21, 2023 06:40 am ET
Merck Provides Update on Phase 3 MOVe-AHEAD Trial Evaluating LAGEVRIO™ (molnupiravir) for Post-exposure Prophylaxis for Prevention of COVID-19
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that LAGEVRIO™ (molnupiravir) did not demonstrate a statistically significant reduction in the risk of COVID-19 following household exposure to another individual with COVID-19. The Phase 3 MOVe-AHEAD trial evaluated people who did not have COVID-19 at baseline (confirmed by a negative baseline SARS-CoV-2 test and no signs and symptoms) but lived with someone who was recently diagnosed with COVID-19. In the primary endpoint of participants who did not have evidence of SARS-CoV-2 infection at baseline (confirm
Feb 17, 2023 06:45 am ET
U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for Merck’s PREVYMIS™ for Prophylaxis of Cytomegalovirus Disease in Kidney Transplant Recipients at High Risk
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental new drug applications (sNDA) for PREVYMIS™ (letermovir). The FDA granted priority review for the sNDA for PREVYMIS for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (D+/R-); the Prescription Drug User Fee Act (PDUFA), or target action date, is June 5, 2023. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in
Feb 16, 2023 12:30 pm ET
Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy Alone in Patients With HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocar
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the pivotal Phase 3 KEYNOTE-859 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. After a median follow-up of 31.0 months (range, 15.3-46.3 months), KEYTRUDA in combination with chemotherapy significantly impro
Feb 16, 2023 10:00 am ET
Merck and AstraZeneca Present Final Results of Key Secondary Overall Survival Endpoint From Phase 3 PROpel Trial at 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the final analysis of the key secondary endpoint of overall survival (OS) from the Phase 3 PROpel trial evaluating LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred), compared to placebo plus abi/pred. Median OS was 42.1 months for the LYNPARZA plus abi/pred arm versus 34.7 months for the placebo plus abi/pred arm, representing a 7.4-month absolute difference in median OS versus a standard of care (at 47.9% maturity, HR=0.81 [95% CI, 0.67-1.00];
Feb 03, 2023 06:45 am ET
Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Therapy for Advanced or Recurrent Endometrial Carcinoma
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 NRG-GY018 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel) met its primary endpoint of progression-free survival (PFS) for the treatment of patients with stage III-IV or recurrent endometrial carcinoma regardless of mismatch repair status. At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with chemotherapy then continued as single agent
Feb 02, 2023 06:30 am ET
Merck Announces Fourth-Quarter and Full-Year 2022 Financial Results
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2022.
Jan 27, 2023 06:45 am ET
FDA Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA Non-Small Cell Lu
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 centimeters [cm]), II, or IIIA non-small cell lung cancer (NSCLC).
Jan 26, 2023 08:02 am ET
Merck Animal Health Receives U.S. FDA Approval of Expanded Indication for BRAVECTO (fluralaner) Chews for Dogs
Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced the U.S. Food and Drug Administration’s approval of an expanded indication for BRAVECTO® Chews for Dogs. The new indication treats and controls Asian longhorned ticks, which are an invasive Ixodid species located across more than one-third of the U.S1,2.
Jan 25, 2023 06:50 am ET
Merck Announces KEYNOTE-991 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Enzalutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer to Stop for Futi
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that it will stop the Phase 3 KEYNOTE-991 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Merck is discontinuing the study based on the recommendation of an independent Data Monitoring Committee which reviewed data from a planned interim analysis. At the interim analysis, KEYTRUDA in combination with enzalutamide and ADT did not demonstrat
Jan 25, 2023 06:45 am ET
Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy in First-Line Advanced or Unresectable Biliary Tract Cancer in KEYNOTE-966 Trial
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive results from the Phase 3 KEYNOTE-966 trial. In the final analysis of this trial, KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone for the first-line treatment of patients with advanced or unresectable biliary tract cancer (BTC). The safety profile of KEYTRUDA in this trial was consistent with that observe
Jan 24, 2023 01:19 pm ET
Merck Announces Second-Quarter 2023 Dividend
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Board of Directors has declared a quarterly dividend of $0.73 per share of the company’s common stock for the second quarter of 2023. Payment will be made on April 10, 2023, to shareholders of record at the close of business on March 15, 2023.
Jan 17, 2023 09:57 pm ET
Merck Selects Perceiv AI for Inaugural Digital Sciences Studio Cohort
Joining the cohort in Cambridge, MA, Perceiv AI will receive direct funding and mentorship from Merck, Northpond Ventures, and McKesson Ventures to advance its prognostic platform focused on multimodal data in neurodegenerative diseases.
Jan 17, 2023 09:57 pm ET
Merck Selects Perceiv AI for Inaugural Digital Sciences Studio Cohort
Joining the cohort in Cambridge, MA, Perceiv AI will receive direct funding and mentorship from Merck, Northpond Ventures, and McKesson Ventures to advance its prognostic platform focused on multimodal data in neurodegenerative diseases.
Jan 11, 2023 06:45 am ET
Merck Completes Tender Offer to Acquire Imago BioSciences, Inc.
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the successful completion of the cash tender offer, through a subsidiary, for all of the outstanding shares of common stock of Imago BioSciences, Inc. (Nasdaq: IMGO), at a purchase price of $36.00 per share in cash, without interest and subject to deduction for any required tax withholding. As of the tender offer expiration at one minute after 11:59 p.m., Eastern Time, on January 10, 2023, 31,307,028 shares of common stock of Imago were validly tendered and not withdrawn from the tender offer, representing
Jan 10, 2023 09:00 am ET
Merck Named One of America’s Most JUST Companies by JUST Capital and CNBC, Industry Leader in Pharmaceuticals and Biotech
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, was named one of America’s Most JUST Companies, making this the sixth consecutive year that Merck has been recognized for its commitment to serving its workers, customers, communities, the environment, and shareholders. Merck ranked No. 26 overall and ranked No. 1 in the pharmaceuticals and biotech industry for the third straight year, notably also ranking as the top company for communities and customers in the industry.
Jan 06, 2023 08:41 am ET
Thinking about trading options or stock in Lamb Weston, Merck, Exxon Mobil, United Airlines, or Apple?
NEW YORK, Jan. 6, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for LW, MRK, XOM, UAL, and AAPL.
Jan 05, 2023 01:05 pm ET
How Merck Is Prioritizing Diversity in Clinical Trials and Why It's So Important
NORTHAMPTON, MA / ACCESSWIRE / January 5, 2023 / Merck & Co., Inc.:
Jan 05, 2023 06:45 am ET
Merck to Hold Fourth-Quarter and Full-Year 2022 Sales and Earnings Conference Call February 2
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its fourth-quarter and full-year 2022 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. ET on Thursday, February 2. During the call, company executives will provide an overview of Merck’s performance for the quarter and outlook.
Jan 04, 2023 08:31 am ET
Thinking about trading options or stock in Baidu, Tesla, Micron Technology, PayPal, or Merck?
NEW YORK, Jan. 4, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for BIDU, TSLA, MU, PYPL, and MRK.
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