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…
Molnupiravir holds up to omicron in lab studies
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…
COVID-19 oral antiviral molnupiravir wins FDA nod
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 advisory committee votes in favor of COVID-19 pill molnupiravir
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…
Why Public Citizen is skeptical about the COVID-19 antiviral molnupiravir
Dr. Michael Carome, director of Public Citizen’s health research group, is concerned about Merck’s SARS-CoV-2 antiviral molnupiravir. If it wins emergency use authorization (EUA), molnupiravir would be the first oral treatment for COVID-19. But Carome brought up several potential problems with molnupiravir during today’s public comment period of the FDA’s Antimicrobial Drugs Advisory Committee meeting.…
Japanese government agrees to buy 1.6 million molnupiravir courses
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…
U.S. to buy 1.4 million additional courses of molnupiravir
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…
UK approves Merck’s oral COVID-19 drug molnupiravir
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…
EMA begins rolling review of Merck’s and Ridgeback’s COVID-19 pill molnupiravir
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…
Everest Organics begins manufacturing API for molnupiravir
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…
A course of Merck’s COVID-19 pill could cost more than $700
Merck’s (NYSE:MRK) oral drug molnupiravir (MK-4482) could be a COVID-19 game-changer, assuming it wins emergency use authorization. The medicine could also be lucrative for Merck, assuming it finds widespread use. Costing $712 for a treatment course, according to a contract obtained by Knowledge Ecology International, molnupiravir’s retail cost would be almost 40 times more than…
Merck finds molnupiravir cuts COVID-19 hospitalization rate in half
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…
25 promising pipeline drugs
The pandemic has heightened interest in COVID-19 therapies, sometimes stealing attention from other pharmaceutical breakthroughs. But the pandemic has also served as a reminder that investment in new drugs can pay dividends while leading to a greater societal appreciation for the industry. A 2019 study published in International Health concluded that pharmaceuticals that have launched…