A recent editorial in the British Medical Journal (BMJ) criticized the decisions of British and U.S. health regulators to authorize the use of the antiviral molnupiravir, the COVID-19 antiviral. The developers of the drug, Merck & Co. (NYSE:MRK) and Ridgeback Biotherapeutics, had announced that molnupiravir lowered the risk of hospital admissions or death by roughly 50% in…

Merck & Co. (NYSE:MRK) and its partner Ridgeback Biotherapeutics have shared data from six preclinical studies showing that the COVID-19 pill molnupiravir was active against the omicron variant in vitro. The two companies continue to seek regulatory authorization for the drug internationally, which is currently authorized in more than 10 countries, including the U.S., the…

Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics have won emergency use authorization from FDA for the investigational oral antiviral molnupiravir (MK-4482, EIDD-2801).  In late November, an FDA advisory panel narrowly voted in favor of authorizing molnupiravir.  FDA recently also granted emergency use authorization to Pfizer’s (NYSE:PFE) oral SARS-CoV-2 antiviral Paxlovid (nirmatrelvir and ritonavir).  FDA’s authorization of…

FDA’s Antimicrobial Drugs Advisory Committee narrowly concluded that the benefits of Merck’s (NYSE:MRK) COVID-19 pill molnupiravir outweigh the risks. A total of 13 members of the panel voted in favor of the drug candidate, while 10 voted against it. There were no abstentions. FDA generally follows the advice of its advisory committees. “This was clearly…

An FDA advisory panel will consider whether emergency use authorization for Merck’s (NYSE:MRK) molnupiravir is warranted. The drug would be the first oral antiviral for COVID-19. Although the conclusions of the Antimicrobial Drugs Advisory Committee are not binding, FDA generally follows its recommendations. The benefit-risk calculation for molnupiravir has grown more complicated recently. Over the…

Merck & Co. (NYSE:MRK) and its partner Ridgeback Biotherapeutics will sell approximately 1.6 million courses of the COVID-19 antiviral molnupiravir (MK-4482, EIDD-2801) to the Japanese government. In related news, Thailand announced that it intends to purchase 50,000 courses of the drug while Taiwan plans on obtaining 10,000 courses.  The U.S. plans on purchasing roughly 3.1…

Merck (NYSE:MRK) and Ridgeback Biotherapeutics appear to be gaining growing support for their oral COVID-19 therapy molnupiravir. One week after Great Britain granted conditional marketing authorization for the drug, the companies announced that the U.S. government intends to purchase 1.4 million additional medicine courses for approximately $1 billion. The U.S. has committed to buy approximately 3.1…

The United Kingdom has become the first country to authorize molnupiravir, the oral antiviral drug from Merck (NYSE:MRK) and Ridgeback Biotherapeutics. The Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for the drug in Great Britain. Furthermore, it has allowed emergency use authorization of the drug for Northern Ireland. MHRA recommends that…

Merck’s (NYSE:MRK) investigational oral COVID-19 drug could net between $5 billion and $7 billion in revenue through the end of 2022 if FDA authorizes its use in December, the company projected. Sales of the drug could be higher, assuming it finds widespread use in wealthy countries. Merck expects sales between $500 million and $1 billion…

Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics has announced that the European Medicines Agency (EMA) has begun a rolling review for molnupiravir, the experimental antiviral that could be the first oral treatment for COVID-19 to hit the market. Merck has also submitted emergency use authorization (EUA) paperwork related to the drug to FDA. The…

Bengaluru, India–based Everest Organics (BOM:524790) saw its share price jump 15% today to ₹347.10 after announcing it has begun manufacturing the active pharmaceutical ingredient (API) for a molnupiravir generic. Molnupiravir is an experimental oral drug that appears to substantially reduce the rate of COVID-19-related hospitalization for patients with mild-to-moderate infections. Reuters has reported that molnupiravir…

The oral antiviral molnupiravir from Merck (NYSE:MRK) and Ridgeback Biotherapeutics fared well in a planned interim analysis of the Phase 3 MOVe-OUT trial. If authorized by FDA, the pill would be the first oral antiviral for SARS-CoV-2 in the U.S. To date, all authorized or approved COVID-19 drugs require subcutaneous, intramuscular or intravenous administration. Merck…

Molnupiravir, an experimental antiviral drug developed by Emory University, Merck (NYSE:MRK) and Ridgeback Biotherapeutics, has promise in the battle against COVID-19 based on an animal trial published in Nature from Georgia State University researchers.   Also known as MK-4482 or EIDD-2801, the oral drug Molnupiravir has an advantage over SARS-CoV-2 therapies such as remdesivir and reconvalescent serum that require infusion.…