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

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

Gilead (GILD), Merck (MRK) Initiate Phase 2 Study Evaluating an Oral Weekly Combination Regimen of Investigational Lenacapavir and Investigational Islatravir for HIV-1 Treatment in Virologically Suppr

Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the start of a Phase 2 clinical study evaluating an investigational once-weekly oral combination treatment regimen of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy.

Partnerships and collaborations are critical to continuing the tremendous progress that has been made toward ending the HIV epidemic, said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. This innovative research... More

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 (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive top-line results from two pivotal Phase 3 trials of the investigational, once-daily oral fixed dose combination pill of doravirine/islatravir (DOR/ISL) in adults with HIV-1 infection who are virologically suppressed on different antiretroviral therapy regimens (ART; ILLUMINATE SWITCH A) or bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF; ILLUMINATE SWITCH B). At 48 weeks, both trials met their primary efficacy endpoint of percentage of participants with HIV-1 RNA levels 50 copies/mL, demonstrating that antiviral efficacy was comparable between DOR/ISL and ART... 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