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

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

October 25, 2021 6:46 AM EDT

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

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

October 25, 2021 6:02 AM EDT

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

Merck (MRK) Announces Voluntary Nationwide Recall of CUBICIN 500mg, Due to Presence of Particulate Matter Identified as Glass Particles

October 20, 2021 5:42 AM EDT

Merck (NYSE: MRK), known as MSD outside the United States and Canada, is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) 500 mg for intravenous use, Lot 934778, Exp June 2022. Because treatment with CUBICIN is likely to be initiated at a hospital or other monitored healthcare setting, the recall is being conducted to the user level, including hospital and administering institutions. Approximately 22,000 vials are affected by this recall. The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of CUBICIN after... More

Gates Foundation to spend $120 million to speed access to generics of Merck COVID-19 pill

October 20, 2021 2:18 AM EDT

By Julie Steenhuysen and Michael Erman

(Reuters) - The Bill & Melinda Gates Foundation said on Wednesday it would spend up to $120 million to kick-start development of generic versions of Merck & Co's oral COVID-19 treatment to help ensure lower-income countries have equal access to the drug.

The aim is to reduce the gap between when wealthy countries have access to the antiviral medicine, molnupiravir, and when the rest of the world can benefit from it.

"To end this pandemic, we need to ensure that everyone, no matter where they live in the world, has access to life-saving health... More

Merck (MRK) Strength Pre-Open Tied to Atea Pharmaceuticals Inc. (AVIR) Trial Missing Primary Endpoint

October 19, 2021 7:09 AM EDT

Merck (NYSE: MRK) Strength Pre-Open Tied to Atea Pharmaceuticals Inc. (NASDAQ: AVIR) Trial Missing Primary Endpoint

Merck up 2.2%, Atea Still Halted... More