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

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

October 27, 2021 6:45 AM EDT

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

October 27, 2021 6:00 AM EDT

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

Evaxion Biotech (EVAX) Announces Proposed Follow-on Public Offering to Raise Additional Capital

October 26, 2021 7:50 AM EDT

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, bacterial diseases and viral infections, announced today that it has filed a registration statement on Form F-1 (the "Registration Statement) with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed follow-on public offering of the Company's ordinary shares, to be delivered in the form of American Depositary Shares ("ADSs"). Evaxion also intends to grant the underwriters a 30-day option to purchase up to an additional... 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

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