Merck (MRK) Reports Positive Top-Line Results from Pivotal Phase 3 Trials Evaluating Combination of Doravirine/Islatravir for the Treatment of People with HIV-1 Infection

Merck (MRK) Reports New Data from Phase 2b Clinical Trial Evaluating Efficacy and Safety of Islatravir in Combination With Doravirine

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced Week 144 data from the Phase 2b dose-ranging study evaluating the antiretroviral activity, tolerability, and safety of islatravir in combination with doravirine compared to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF)... More

Merck (MRK) Announces License Agreement with The Medicines Patent Pool for Molnipiravir

The Medicines Patent Pool (MPP) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the signing of a voluntary licensing agreement to facilitate affordable global access for molnupiravir, an investigational oral COVID-19 antiviral medicine for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. This agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries (LMICs) following appropriate regulatory approvals. Merck and Ridgeback Biotherapeutics are jointly developing molnupiravir.

Under the terms of the... More

EU regulator starts real-time review of Merck's COVID-19 pill

(Reuters) - U.S. drugmaker Merck & Co Inc said on Monday the European Union's drug regulator has initiated a real-time review of its experimental COVID-19 antiviral drug for adults.

Under the procedure, also known as a "rolling review", the European Medicines Agency (EMA) would assess data as soon as it becomes available, instead of waiting for a formal application when all required information has been gathered.

Merck (MRK) And Ridgeback Announce Initiation of a Rolling Review by EU Agency for Molnupiravir,

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the European Medicines Agency (EMA) has initiated a rolling review for molnupiravir, an investigational oral antiviral medicine, for the treatment of COVID-19 in adults. Merck plans to work with the EMAs Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application. As previously... More

Evaxion Biotech (EVAX) Announces Clinical Collaboration with Merck (MRK) to Evaluate Lead Product Candidate with KEYTRUDA

Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, announced today that it has entered into a clinical trial collaboration and supply agreement with subsidiaries of Merck & Co (NYSE: MRK), Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), to evaluate the combination of Evaxions cancer... More

Merck (MRK) Announces European Commission Approves KEYTRUDA Plus Chemotherapy as Treatment for Certain Patients With Locally Recurrent Unresectable or Metastatic TNBC

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Mercks anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors express PD-L1 (Combined Positive Score [CPS] 10) and who have not received prior chemotherapy for metastatic disease. Triple-negative breast cancer is an aggressive type of breast cancer. This represents KEYTRUDAs first approval in Europe in a breast cancer setting.

The approval is based on final... More

CDC ACIP Unanimously Votes to Recommends Merck's (MRK) VAXNEUVANCE in Series with PNEUMOVAX as Option for Pneumococcal Vaccination in Appropriate Adults

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Centers for Disease Control and Preventions (CDCs) Advisory Committee on Immunization Practices (ACIP) unanimously voted in favor of updates to pneumococcal vaccination recommendations for adults 65 years and older, and for adults ages 19 to 64 with certain underlying medical conditions (e.g., chronic conditions such as diabetes, chronic heart disease, chronic lung disease, or chronic liver disease, as well as HIV, an immunocompromising condition) or other disease risk factors (e.g., smoking, alcoholism). In both groups, the ACIP voted to... More