Merck & Co Inc (N:MRK)

Business Focus: Pharmaceuticals

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.

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

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.

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

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.

Jan 03, 2023 06:45 am ET

Merck to Present at the 41st 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 41st Annual J.P. Morgan Healthcare Conference on Monday, Jan. 9, 2023, at 5:15 p.m. PT / 8:15 p.m. ET.

Dec 30, 2022 08:31 am ET

Thinking about trading options or stock in Tesla, Merck, Amazon, Meta, or Johnson & Johnson?

NEW YORK, Dec. 30, 2022 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for TSLA, MRK, AMZN, META, and JNJ.

Dec 22, 2022 07:00 am ET

Merck to Present at the Goldman Sachs Healthcare CEOs 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 CEOs Unscripted Conference on Thursday, Jan. 5, 2023, at 8:55 a.m. ET.

Dec 22, 2022 06:45 am ET

Merck and Kelun-Biotech Announce Exclusive License and Collaboration Agreement for Seven Investigational Antibody-drug Conjugate Candidates for the Treatment of Cancer

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Kelun-Biotech (a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd), a clinical-stage biotech company focused on biologic and small molecule discovery and development, today announced that the companies have entered into an exclusive license and collaboration agreement to develop seven investigational preclinical antibody-drug conjugates (ADC) for the treatment of cancer.

Dec 21, 2022 09:00 am ET

Merck Video: What the “Great Resignation” Taught Us About Workplace Culture

NORTHAMPTON, MA / ACCESSWIRE / December 21, 2022 / The global workforce is going through a significant transformation. In 2021, an unprecedented number of workers quit their jobs. What started as an economic trend called the "great resignation" has spurred lasting workplace changes.

Dec 21, 2022 06:45 am ET

LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone Approved in the EU as Treatment for Certain Patients With Metastatic Castration-Resistant Prostate Cancer

AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA has been approved in the European Union (EU) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Dec 20, 2022 06:45 am ET

Seagen, Astellas and Merck Announce FDA Acceptance of sBLAs for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced

“We look forward to working closely with the FDA as we seek potential accelerated approval for this combination in the hopes that it can be another treatment option for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy,” said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas.

Dec 20, 2022 05:45 am ET

Astellas, Seagen and Merck Announce FDA Acceptance of Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of C

– This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting –

Dec 16, 2022 08:45 am ET

Merck Leaders Recognized As Influential Women Executives

NORTHAMPTON, MA / ACCESSWIRE / December 16, 2022 / WomenInc., a media platform that showcases and drives positive dialogue about women, recognized three Merck leaders in its just-released list: 2022 Most Influential Women Executives in Corporate America. They are Cristal Downing, EVP and chief communications and public affairs officer, Caroline Litchfield, EVP and chief financial officer, and Jennifer Zachary, EVP a

Dec 15, 2022 06:45 am ET

AstraZeneca and Merck Provide Update on US Regulatory Review of LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone as Treatment of Metastatic Castration-Resistant Pros

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) has informed AstraZeneca that the agency will extend by three months the Prescription Drug User Fee Act (PDUFA) date for the pending supplemental new drug application (sNDA) for LYNPARZA in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The purpose of the extension is to provide further time for the full review of the submission. The

Dec 13, 2022 07:00 am ET

Moderna and Merck Announce mRNA-4157/V940, an Investigational Personalized mRNA Cancer Vaccine, in Combination with KEYTRUDA(R) (pembrolizumab), Met Primary Efficacy Endpoint in Phase 2b KEYNOTE-942 T

mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to KEYTRUDA monotherapy in stage III/IV melanoma patients with high risk of recurrence following complete resection

Dec 12, 2022 06:45 am ET

Merck Begins Tender Offer to Acquire Imago BioSciences, Inc.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, is commencing today, through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Imago BioSciences, Inc. (Nasdaq: IMGO). On Nov. 21, 2022, Merck announced that it had entered into a definitive agreement to acquire Imago.

Dec 05, 2022 12:21 pm ET

BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations:) Apollo Endosurgery, Inc. (Nasdaq - APEN), Imago BioSciences, Inc. (Nasdaq - IMGO), Opiant Pharmaceuticals Inc.

Dec 02, 2022 08:15 am ET

In Burkina Faso, a Personal Mission To Make a Difference in One Community

NORTHAMPTON, MA / ACCESSWIRE / December 2, 2022 / Merck & Co., Inc.

Dec 01, 2022 06:45 am ET

Merck to Present Data From Its Hematology Portfolio and Promising Pipeline at the 64th American Society of Hematology (ASH) Annual Meeting

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of findings from clinical trials and real-world studies at the upcoming 64th American Society of Hematology (ASH) Annual Meeting from Dec. 10-13, 2022, in New Orleans, Louisiana and virtually. New and updated data for KEYTRUDA, Merck’s anti-PD-1 therapy, as well as from the company’s investigational medicines favezelimab (anti-LAG-3 antibody), zilovertamab vedotin (antibody-drug conjugate targeting receptor tyrosine kinase-like orphan receptor 1 [ROR1]), and nemtabrutinib (rever

Nov 29, 2022 11:41 am ET

Merck Announces First-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 first quarter of 2023. Payment will be made on Jan. 9, 2023, to shareholders of record at the close of business on Dec.15, 2022.

Nov 22, 2022 06:45 am ET

Merck Announces Phase 3 KEYNOTE-859 Trial Met Primary Endpoint of Overall Survival in Patients With HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the pivotal Phase 3 KEYNOTE-859 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. KEYTRUDA in combination with chemotherapy showed a statistically significant and clinically meaningful improvement in the trial’s primary endpoint of overall survival (OS) versus ch

Nov 21, 2022 03:28 pm ET

SHAREHOLDER ALERT: Weiss Law Investigates Imago BioSciences, Inc.

NEW YORK, Nov. 21, 2022 /PRNewswire/ -- Weiss Law is investigating possible breaches of fiduciary duty and other violations of law by the board of directors of Imago BioSciences, Inc. ("Imago" or the "Company") (NASDAQ: IMGO), in connection with the tender offer for the Company by a subsidiary of Merck & Co., Inc. (NYSE: MRK). Under the tender offer terms, the Company's shareholders will receive $36.00 in cash for each share of Imago common stock owned. The transaction is valued at $1.35 billion.

Nov 21, 2022 08:31 am ET

Thinking about trading options or stock in Walt Disney, HCA Healthcare, DICK'S Sporting Goods, Apple, or Merck?

NEW YORK, Nov. 21, 2022 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for DIS, HCA, DKS, AAPL, and MRK.

Nov 21, 2022 06:45 am ET

Merck to Acquire Imago BioSciences, Inc.

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Imago BioSciences, Inc. (“Imago”) (Nasdaq: IMGO) today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Imago for $36.00 per share in cash for an approximate total equity value of $1.35 billion.

Nov 21, 2022 06:45 am ET

Merck to Present at the 5th Annual Evercore ISI HealthCONx Conference

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Dr. Eliav Barr, senior vice president and head of Global Clinical Development, chief medical officer, Merck Research Laboratories, is scheduled to participate in a virtual fireside chat at the 5th Annual Evercore ISI HealthCONx Conference on Thursday, Dec. 1, 2022 at 9:40 a.m. ET.

Nov 14, 2022 06:45 am ET

LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone Receives Positive Opinion From EU CHMP as Treatment for Certain Patients With Metastatic Castration-Resistant Prosta

AstraZeneca and 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) has adopted a positive opinion recommending approval of LYNPARZA in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Nov 09, 2022 10:40 am ET

Our Partnerships Help Make Vaccines Accessible Worldwide

NORTHAMPTON, MA / ACCESSWIRE / November 9, 2022 / Providing vaccines to some of the hardest-to-reach places around the world

Nov 07, 2022 06:45 am ET

Reductions in Certain Types of HPV-Related Cervical and Non-Cervical Diseases in Women and Men Observed with Real-World Use of Merck's GARDASIL® in Systematic Literature Review of 138 Studies

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that an updated systematic literature review examining the global impact and effectiveness of HPV vaccination using GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] was published online in the journal Expert Review of Vaccines. This systematic review observed that use of GARDASIL led to reductions in the rates of high-grade (precancerous) and low-grade cervical lesions, as well as reductions in certain non-cervical HPV-related diseases and HPV infection in women an

Nov 02, 2022 09:00 am ET

Dedicated To Developing Women Leaders

NORTHAMPTON, MA / ACCESSWIRE / November 2, 2022 / Merck & Co., Inc.

Nov 01, 2022 07:03 am ET

Veeva and Merck Form Long-Term Strategic Partnership

Ten-year partnership will help Merck reduce operational costs, deliver value to patients, and optimize the healthcare professional and patient experience

Oct 27, 2022 06:30 am ET

Merck Announces Third-Quarter 2022 Financial Results

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2022.

Oct 26, 2022 05:00 pm ET

Robert M. Davis to Succeed Kenneth C. Frazier as Chairman of Merck

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Merck board of directors has unanimously elected Robert M. Davis to serve as chairman of the board, effective Dec. 1, 2022. He will succeed Kenneth C. Frazier, who plans to retire on Nov. 30, 2022, after a long-tenured career at Merck that began in 1992. Frazier led the company for 10 years as president and chief executive officer, from 2011 through 2021. He has served as a Merck director since January 2011 and chairman of its board of directors since December 2011.

Oct 24, 2022 09:31 am ET

Thinking about trading options or stock in Netflix, Apple, Lockheed Martin, Merck, or Chevron?

NEW YORK, Oct. 24, 2022 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for NFLX, AAPL, LMT, MRK, and CVX.

Oct 24, 2022 06:45 am ET

European Commission Expands Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) Indication to Include Infants, Children and Adolescents

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 VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) to include active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae (S. pneumoniae) in infants, children and adolescents from 6 weeks to less than 18 years of age. The approval facilitates availability of VAXNEUVANCE for this population in all 27 European Union (EU) Member States plus Iceland, N

Oct 22, 2022 03:00 pm ET

Merck’s PREVYMIS™ Demonstrates Efficacy in Phase 3 Study for Prevention of Cytomegalovirus Disease in Adults After Kidney Transplantation

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today the presentation of findings from a Phase 3 clinical trial that assessed safety and efficacy of PREVYMIS™ (letermovir) compared to valganciclovir for cytomegalovirus (CMV) prophylaxis in 601 adult kidney transplant recipients at high risk for CMV disease (D+/R-). At 52 weeks following kidney transplant, trial results met the primary endpoint demonstrating that PREVYMIS was effective and non-inferior to valganciclovir for preventing CMV disease -- 10.4% (n=30) of participants who received PREVYMIS developed

Oct 19, 2022 09:10 am ET

Merck Recognized on Fortune's 2022 Change the World List for Expanding Access to HPV Vaccines

RAHWAY, NJ / ACCESSWIRE / October 19, 2022 / Merck (NYSE:MRK), known as MSD outside the United States and Canada, has been named to Fortune's 2022 Change the World list. The annual list recognizes companies that have had a positive social impact through activities that are part of their core business strategy. Merck was selected for its work expanding global access to the company's human papillomavirus (HPV) vaccines.

Oct 18, 2022 09:31 am ET

Thinking about trading options or stock in Merck, Tesla, Advanced Micro Devices, Salesforce, or Atlassian?

NEW YORK, Oct. 18, 2022 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for MRK, TSLA, AMD, CRM, and TEAM.

Oct 18, 2022 09:07 am ET

Merck Animal Health Launches Sure Petcare Animo® GPS

New smart device provides geolocation and dog behavioral tracking capabilities

Oct 18, 2022 06:45 am ET

Merck and the Bill & Melinda Gates Medical Research Institute Announce Licensing Agreement for Novel Tuberculosis Antibiotic Candidates

Merck, (NYSE: MRK), known as MSD outside of the United States and Canada, and the Bill & Melinda Gates Medical Research Institute (Gates MRI) today announced a licensing agreement for two preclinical antibacterial candidates for evaluation as potential components of combination regimens for the treatment of tuberculosis (TB). These candidates were discovered by Merck scientists as part of the TB Drug Accelerator (TBDA). The TBDA is a collaboration established among biopharmaceutical companies, research organizations and universities to accelerate the discovery and development of novel therapeu

Oct 12, 2022 07:05 am ET

Health Canada Approves KEYTRUDA® (pembrolizumab) as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrecto

Approval Based on Data from the Phase 3 KEYNOTE-564 Trial

Oct 10, 2022 09:38 am ET

Thinking about trading options or stock in Tesla, ConocoPhillips, Humana, Lockheed Martin, or Merck?

NEW YORK, Oct. 10, 2022 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for TSLA, COP, HUM, LMT, and MRK.

Oct 10, 2022 08:00 am ET

Merck Recognized on Fortune’s 2022 Change the World List for Expanding Access to HPV Vaccines

Merck (NYSE: MRK), known as MSD outside the United States and Canada, has been named to Fortune’s 2022 Change the World list. The annual list recognizes companies that have had a positive social impact through activities that are part of their core business strategy. Merck was selected for its work expanding global access to the company’s human papillomavirus (HPV) vaccines.

Oct 10, 2022 06:45 am ET

Merck Announces Positive Top-line Results from Pivotal Phase 3 STELLAR Trial Evaluating Sotatercept for the Treatment of Adults with Pulmonary Arterial Hypertension (PAH)

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive top-line results from the pivotal Phase 3 STELLAR trial evaluating the safety and efficacy of sotatercept, an investigational activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein being evaluated as an add-on to stable background therapy for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1). The trial met its primary efficacy outcome measure, demonstrating a statistically significant and clinically meaningful improvement in 6-minute walk distance (6MWD, which measures how far

Oct 06, 2022 07:50 pm ET

Merck and Ridgeback Biotherapeutics Provide Update on New Clinical and Non-Clinical Studies of LAGEVRIO™ (molnupiravir)

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today issued the following announcement regarding data from two real-world evidence studies evaluating LAGEVRIO™ (molnupiravir), an investigational oral antiviral COVID-19 medicine. The first study, PANORAMIC, was conducted by the University of Oxford in the UK in highly-vaccinated adults mostly less than age 65 during the period when the circulating SARS-CoV-2 variant was predominantly Omicron. The second study, Clalit, was conducted by investigators in Israel in mostly older adults with underl

Sep 29, 2022 03:22 pm ET

U.S. Court of Appeals for the Federal Circuit Rules in Favor of Merck in Sitagliptin Dihydrogen Phosphate Patent Lawsuit

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Court of Appeals for the Federal Circuit ruled in favor of the company in a patent challenge brought by Mylan Pharmaceuticals, Inc. (now Viatris) related to sitagliptin dihydrogen phosphate, an active ingredient in JANUVIA® (sitagliptin), JANUMET® (sitagliptin and metformin hydrochloride) and JANUMET® XR (sitagliptin and metformin hydrochloride extended-release).

Sep 29, 2022 06:45 am ET

Merck to Hold Third-Quarter 2022 Sales and Earnings Conference Call October 27

Merck (NYSE: MRK), known as MSD outside the United States and Canada, will hold its third-quarter 2022 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. ET on Thursday, October 27. During the call, company executives will provide an overview of Merck’s performance for the quarter and outlook.

Sep 27, 2022 07:00 am ET

Merck Animal Health Completes Minority Investment in LeeO Precision Farming

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), announced today that it has completed a minority investment in LeeO Precision Farming B.V. (LeeO). Merck Animal Health also will assume distribution of LeeO’s digital swine traceability solution in selected markets over the coming months. Merck Animal Health joins LeeO’s existing founders and shareholders, Prairie Systems, Inc., a strategic investment of United Animal Health, Inc., and MIQ B.V. Specific terms of the minority investment were not

Sep 27, 2022 06:45 am ET

Merck’s KEYTRUDA® (pembrolizumab) Receives Four New Approvals in Japan, Including in High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC)

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that KEYTRUDA, Merck’s anti-PD-1 therapy, received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW):

Sep 23, 2022 09:31 am ET

Thinking about trading options or stock in Advanced Micro Devices, Tesla, Hershey, Merck, or Exxon Mobil?

NEW YORK, Sept. 23, 2022 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for AMD, TSLA, HSY, MRK, and XOM.

Sep 22, 2022 07:30 am ET

Merck Animal Health to Acquire Vence

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), announced today that it has signed a definitive agreement under which Merck Animal Health will acquire Vence from its founders and shareholders. Vence is an innovator in virtual fencing for rotational grazing and livestock management. The acquisition is expected to be completed in the third quarter of 2022, subject to customary closing conditions. Specific terms of the agreement were not disclosed.

Sep 22, 2022 06:45 am ET

LYNPARZA® (olaparib) Approved in China as First-Line Maintenance Treatment With Bevacizumab for Homologous Recombination Deficient (HRD)-Positive Advanced Ovarian Cancer

AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA has been approved in China as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.

Sep 22, 2022 06:40 am ET

U.S. District Court Rules In Favor of Merck in Sitagliptin Phosphate Patent Lawsuit

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. District Court for the Northern District of West Virginia ruled in favor of the company in a patent infringement suit against Viatris related to sitagliptin, an active ingredient in JANUVIA, JANUMET and JANUMET XR. The Court found that both Merck patents at issue were valid and infringed. The decision is subject to appeal.

Sep 20, 2022 06:45 am ET

Merck to Initiate New Phase 3 Clinical Program with Lower Dose of Daily Oral Islatravir in Combination with Doravirine for Treatment of People with HIV-1 Infection

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the company will initiate a new Phase 3 clinical program with once-daily islatravir for the treatment of people with HIV-1 infection. These new Phase 3 studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of islatravir (DOR/ISL). One study will evaluate DOR/ISL in previously untreated adults with HIV-1 infection and two studies will evaluate DOR/ISL as a switch in antiretroviral therapy (ART) in adults with HIV-1 infection who are virologically suppressed. Certain

Sep 16, 2022 07:30 am ET

Merck Receives Positive CHMP Opinion for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in Infants and Children

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. VAXNEUVANCE is currently authorized for use in the European Union (EU) for

Sep 13, 2022 07:05 am ET

Health Canada Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adults and Children with Stage IIB or IIC Melanoma Following Complete Resection

Approval is based on the Phase 3 KEYNOTE-716 Trial

Sep 12, 2022 08:55 am ET

Astellas, Seagen and Merck Announce Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) and PADCEV as Monotherapy in First-Line Advanced Urothelial

– Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab –

Sep 12, 2022 08:55 am ET

Seagen, Astellas and Merck Announce Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) and PADCEV as Monotherapy in First-Line Advanced Urothelial

Seagen Inc. (Nasdaq:SGEN), Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the phase 1b/2 EV-103 clinical trial (also known as KEYNOTE-869) Cohort K investigating PADCEV® (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and PADCEV alone as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer (la/mUC) who are ineligible to receive cispla

Sep 11, 2022 04:15 am ET

Five-Year Data for Merck's KEYTRUDA® (pembrolizumab) Plus Chemotherapy Showed Sustained Survival Benefit Versus Chemotherapy Alone in Two Studies for Metastatic Non-Small Cell Lung Cancer (NSCLC)

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced KEYTRUDA, Merck’s anti-PD-1 therapy, plus chemotherapy continued to demonstrate a survival benefit and durable responses in two five-year exploratory analyses of pivotal Phase 3 studies as first-line treatment for metastatic non-small cell lung cancer (NSCLC):

Sep 10, 2022 02:30 am ET

Merck and Eisai Present Results From Phase 3 LEAP-002 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Versus LENVIMA Monotherapy in Patients With Unresectable Hepatocellular Carc

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced the first presentation of results from the final analysis of the Phase 3 LEAP-002 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, versus LENVIMA monotherapy as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). Results are being presented during a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2022, being held

Sep 09, 2022 08:00 am ET

LYNPARZA® (olaparib) in Combination With Bevacizumab, and as Monotherapy, Demonstrates Clinically Meaningful Long-Term Survival in Certain Patients With First-Line Advanced Ovarian Cancer in Explorato

AstraZeneca and Merck, known as MSD outside of the United States and Canada, today announced long-term follow-up results from the Phase 3 PAOLA-1 and SOLO-1 trials in first-line advanced ovarian cancer, which represent the longest-term data for any PARP inhibitor in this setting.

Sep 08, 2022 10:00 am ET

Merck Foundation Launches $20 Million Initiative to Advance Equity in U.S. Cancer Care

The Merck Foundation (the Foundation) announced today the launch of the Alliance for Equity in Cancer Care (the Alliance), a $20 million, five-year initiative, designed to make cancer care more equitable in the United States by helping patients living in underserved communities receive timely access to high-quality, culturally responsive care.

Sep 06, 2022 06:45 am ET

Merck to Present at the Morgan Stanley 20th Annual Global Healthcare Conference

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Robert M. Davis, chief executive officer and president, and Dr. Dean Li, president, Merck Research Laboratories, are scheduled to participate in a virtual fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on Monday, Sept. 12, 2022, at 2:15 p.m. EDT.

Aug 30, 2022 04:01 pm ET

Merck Reports Strong Progress in ESG Focus Areas

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today issued its 2021/2022 Environmental, Social and Governance (ESG) Progress Report. The report highlights the company’s performance and progress in its four ESG focus areas: Access to Health, Employees, Environmental Sustainability and Ethics & Values.

Aug 29, 2022 06:45 am ET

Merck to Present New Data at ESMO 2022 Congress From Its Broad Oncology Portfolio and Promising Pipeline, Demonstrating Commitment to Improving Long-Term Survival in Multiple Types of Cancer

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that research spanning 16 different cancer types will be presented at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris, France from Sept. 9-13. The breadth of data showcases the continued impact of Merck’s portfolio of oncology medicines and the potential of Merck's innovative oncology pipeline.

Aug 25, 2022 06:45 am ET

LYNPARZA® (olaparib) Approved in Japan as Adjuvant Treatment for Patients With BRCA-Mutated, HER2-Negative High Recurrent Risk Breast Cancer

AstraZeneca and Merck, known as MSD outside of the United States and Canada, today announced that LYNPARZA has been approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the adjuvant treatment for patients with BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2)-negative high recurrent risk breast cancer.

Aug 23, 2022 06:45 am ET

Merck Receives Fast Track Designation from the U.S. FDA for MK-2060, an Investigational Anticoagulant Therapy

Merck, (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck’s investigational anticoagulant therapy MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD). According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation ma

Aug 16, 2022 07:00 am ET

FDA Accepts Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone for Patients With Metastatic Castration-Resistant Pr

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA in combination with abiraterone and prednisone or prednisolone has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date in the fourth quarter of 2022.

Aug 16, 2022 06:45 am ET

Merck and Orna Therapeutics Collaborate to Advance Orna’s Next Generation of RNA Technology

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Orna Therapeutics, a biotechnology company pioneering a new investigational class of engineered circular RNA (oRNA) therapies, today announced a collaboration agreement to discover, develop, and commercialize multiple programs, including vaccines and therapeutics in the areas of in

Aug 04, 2022 06:45 am ET

LYNPARZA® (olaparib) Approved in the EU as Adjuvant Treatment for Patients With Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved LYNPARZA as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

Aug 03, 2022 06:45 am ET

Merck and Eisai Provide Update on Phase 3 LEAP-002 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Versus LENVIMA Monotherapy in Patients With Unresectable Hepatocellular Carcino

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the Phase 3 LEAP-002 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, versus LENVIMA monotherapy did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). There were trends toward improvement in OS and PFS for patients who received KEYTRUDA plus LENVIMA vers

Aug 03, 2022 06:40 am ET

Merck Provides Update on Phase 3 KEYNOTE-921 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Chemotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-921 trial evaluating KEYTRUDA in combination with chemotherapy (docetaxel) compared to chemotherapy alone did not meet its dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). In the study, there were modest trends toward an improvement in both OS and rPFS for patients who received KEYTRUDA plus chemotherapy compared with chemotherapy alone; however,

Jul 28, 2022 06:30 am ET

Merck Announces Second-Quarter 2022 Financial Results

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2022.

Jul 26, 2022 12:40 pm ET

Merck Announces Fourth-Quarter 2022 Dividend

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company’s common stock for the fourth quarter of 2022. Payment will be made on Oct. 7, 2022, to shareholders of record at the close of business on Sept. 15, 2022.

Jul 20, 2022 06:45 am ET

Merck Provides Update on Phase 3 KEYNOTE-412 Trial in Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-412 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, with concurrent chemoradiation therapy (CRT) followed by KEYTRUDA as maintenance therapy (the KEYTRUDA regimen), did not meet its primary endpoint of event-free survival (EFS) for the treatment of patients with unresected locally advanced head and neck squamous cell carcinoma (HNSCC). At the final analysis of the study, there was an improvement in EFS for patients who received the KEYTRUDA regimen co

Jul 13, 2022 06:00 am ET

Merck and Orion Announce Global Collaboration for the Development and Commercialization of ODM-208, an Investigational Steroid Synthesis Inhibitor for the Treatment of Metastatic Castration-Resistant

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Orion Corporation (“Orion”) today announced a global development and commercialization agreement for Orion’s investigational candidate ODM-208 and other drugs targeting cytochrome P450 11A1 (CYP11A1), an enzyme important in steroid production. ODM-208 is an oral, non-steroidal inhibitor of CYP11A1 currently being evaluated in a Phase 2 clinical trial for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

Jul 12, 2022 09:35 am ET

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Jun 29, 2022 07:00 am ET

Merck Announces the Launch of the Merck Digital Sciences Studio to Help Healthcare Startups Quickly Bring their Innovations to Market

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the launch of the Merck Digital Sciences Studio (MDSS) to enable the generation of innovative technologies for drug discovery and development. MDSS will support early-stage biomedical startups with direct investment, access to powerful Azure Cloud computing and opportunities to pilot their technologies in collaboration with discovery and clinical scientists at Merck. Starting today, Merck welcomes applications for 12 spots for the first MDSS cohort. Startups developing artificial intelligence (AI) and machine

Jun 29, 2022 06:45 am ET

Merck to Hold Second-Quarter 2022 Sales and Earnings Conference Call July 28

Merck (NYSE: MRK), known as MSD outside the United States and Canada, will hold its second-quarter 2022 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. ET on Thursday, July 28. During the call, company executives will provide an overview of Merck’s performance for the quarter and outlook.

Jun 27, 2022 06:45 am ET

LYNPARZA® (olaparib) Receives Positive Opinion From EU CHMP as Adjuvant Treatment for Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of LYNPARZA for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.

Jun 24, 2022 06:45 am ET

European Commission Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Adolescent Patients (≥12 Years of Age) With Stage IIB or IIC Melanoma Following Complete Resection

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection. Additionally, the EC approved expanding the indications for KEYTRUDA in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older.

Jun 22, 2022 06:28 pm ET

CDC’s ACIP Unanimously Votes to Provisionally Recommend Use of Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) as an Option for Pneumococcal Vaccination in Infants and Children

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted to include VAXNEUVANCETM (Pneumococcal 15-valent Conjugate Vaccine) as a recommended option for vaccination in infants and children, including routine use in children under 2 years of age. Specifically, the ACIP voted to recommend that VAXNEUVANCE may be used as an option to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for children aged

Jun 22, 2022 06:45 am ET

U.S. FDA Approves Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Infants and Children

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) to include children 6 weeks through 17 years of age. VAXNEUVANCE is now indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older. The approval follows the FDA’

Jun 21, 2022 04:30 pm ET

Results From Phase 3 PROpel Trial of LYNPARZA® (olaparib) Plus Abiraterone in First-Line Metastatic Castration-Resistant Prostate Cancer Published in NEJM Evidence

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the results from the Phase 3 PROpel trial have been published in NEJM Evidence. Results from the trial showed that LYNPARZA in combination with abiraterone plus prednisone significantly improved radiographic progression-free survival (rPFS) versus abiraterone plus prednisone, a standard of care, as first-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations.

Jun 21, 2022 04:10 pm ET

Merck Announces that Chirfi Guindo will Lead Marketing for Merck Human Health

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that Chirfi Guindo will lead Human Health Marketing as chief marketing officer for Merck Human Health, and will join Merck’s Executive Team, effective July 1, 2022. Guindo will report directly to Robert M. Davis, chief executive officer and president, Merck. As previously announced, Jannie Oosthuizen leads Merck Human Health U.S., and Joe Romanelli will lead Merck Human Health International effective Aug. 1, both also reporting to Davis. Deepak Khanna, interim leader of Human Health Internationa

Jun 21, 2022 06:45 am ET

Merck Presents Positive Results from Phase 1/2 Study Evaluating V116, the Company’s Investigational Pneumococcal Conjugate Vaccine for Adults

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of positive results from the Phase 1/2 study,

Jun 13, 2022 06:45 am ET

FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Stage IB (≥4 centimeters)-IIIA Non-Small Cell Lung Cancer Following Complete Surgical Resection

Merck (NYSE: MRK), known as MSD outside 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 for the adjuvant treatment of patients with stage IB (≥4 centimeters), II or IIIA non-small cell lung cancer (NSCLC) following complete surgical resection. The sBLA is based on data from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS, conducted in collaboration with the European Organisation for Research and Treatment

Jun 08, 2022 06:51 am ET

Merck to Participate in the 2022 Goldman Sachs 43rd Annual Global Healthcare Conference

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that Robert M. Davis, chief executive officer and president, and Dean Y. Li, president, Merck Research Laboratories, will participate in a fireside chat at the live 2022 Goldman Sachs 43rd Annual Global Healthcare Conference.

Jun 07, 2022 06:45 am ET

Merck and Ridgeback Announce New Data For Investigational LAGEVRIO™ (molnupiravir) From Phase 3 MOVe-OUT Study

Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced the Annals of Internal Medicine has published additional data from the Phase 3 MOVe-OUT trial evaluating LAGEVRIO™ (molnupiravir), an investigational oral antiviral medicine, in non-hospitalized adults

Jun 07, 2022 06:30 am ET

Merck to Hold Investor Event to Highlight Oncology Portfolio and Pipeline

Merck (NYSE: MRK), known as MSD outside the United States and Canada, will provide a detailed overview of the company’s oncology portfolio and pipeline at an investor event today at the 2022 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago at 7 a.m. CT/8 a.m. ET. At this year’s ASCO, data for Merck’s oncology portfolio and pipeline will be presented from nearly 120 abstracts in more than 25 cancer types.

Jun 05, 2022 08:00 am ET

Adjuvant Treatment With Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Statistically Significant & Clinically Meaningful Improvement in Distant Metastasis-Free Survival in Patients With Resected Stage

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced distant metastasis-free survival (DMFS) results from the Phase 3 KEYNOTE-716 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, versus placebo as adjuvant therapy for patients with resected stage IIB or IIC melanoma. With a median follow-up of 27.4 months, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in DMFS versus placebo (HR=0.64 [95% CI, 0.47-0.88]; p=0.0029). Median DMFS was not reached in either arm. These late-breaking data are being presented for the fir

May 24, 2022 01:46 pm ET

Merck Announces Third-Quarter 2022 Dividend

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company’s common stock for the third quarter of 2022. Payment will be made on July 8, 2022 to shareholders of record at the close of business on June 15, 2022.

May 24, 2022 06:45 am ET

European Commission Approves KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Adjuvant Monotherapy After Surgery for Locally Advanced or Early-Stage Triple-Negat

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence.

May 20, 2022 08:15 am ET

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Adolescent (≥12 Years of Age) Patients With Stage IIB or IIC Melanoma Following Complete Resec

Merck (NYSE: MRK), known as MSD outside 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, as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection. Additionally, the CHMP recommended expanding the indications for KEYTRUDA in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatmen

May 12, 2022 09:31 am ET

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May 10, 2022 06:45 am ET

Merck To Present Data at 2022 ASCO Annual Meeting Highlighting Promising Pipeline Medicines and Significant Progress in Treating Earlier Stages of Certain Cancers With KEYTRUDA® (pembrolizumab)

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that data for six approved medicines and pipeline candidates in more than 25 types of cancer will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 3-7. Presentations will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA; WELIREG™ (belzutifan); LYNPARZA® (olaparib, in collaboration with AstraZeneca); and LENVIMA® (lenvatinib, in collaboration with Eisai). Additionally, Merck will present dat

May 04, 2022 06:45 am ET

Merck to Participate in Bank of America Securities 2022 Healthcare Conference

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that Executive Vice President and Chief Financial Officer Caroline Litchfield will participate in a fireside chat at the live Bank of America Securities 2022 Healthcare Conference.

May 02, 2022 09:31 am ET

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NEW YORK, May 2, 2022 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for MRK, TSLA, NFLX, AMD, and BAC.

Apr 29, 2022 06:45 am ET

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With Microsatellite Instability-High (MSI-H) or Deficient Mismatch Repair (dMMR) Tumors in Five Different Types of Cancer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumors in adults with: unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy; advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative

Apr 29, 2022 06:30 am ET

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Expres

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). This approval is based on results from the Phase 3 KEYNOTE-826 trial, in which KEYTRUDA plus chemotherapy with or without bevacizumab (the KEYTRUDA regimen) demonstrated a statistically significant improvement in overall survi

Apr 28, 2022 06:30 am ET

Merck Announces First-Quarter 2022 Financial Results

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2022.

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