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☆ US Shifting COVID Antivirals to Commercial Market on Nov. 1
▼ + stars: | 2023-10-27 | by ( Oct. | At P.M. | ) www.usnews.com time to read: +2 min

The government has been overseeing distribution of the treatments, alongside vaccines and tests, but has transferring that work to traditional commercial channels. Commercial ordering for the treatments is set to start on Nov. 1. The U.S. government paid around $530 per course for Paxlovid, the most commonly prescribed at home COVID-19 treatment in the country, and made it available at no cost. Returns will begin on Nov. 15, the official said, and will be accepted through the end of the year. The government is recommending returns start in December enough time for the establishment of patient assistance programs and securing of commercially-labeled doses.

Persons: Ahmed Aboulenein WASHINGTON, Lagevrio, Ahmed Aboulenein, Marguerita Choy Organizations: U.S, Pfizer, Paxlovid, U.S . Department of Health, Human Services Locations: U.S

The government has been overseeing distribution of the treatments, alongside vaccines and tests, but has transferring that work to traditional commercial channels. Commercial ordering for the treatments is set to start on Nov. 1. Returns will begin on Nov. 15, the official said, and will be accepted through the end of the year. The government is recommending returns start in December enough time for the establishment of patient assistance programs and securing of commercially-labeled doses. Reporting by Ahmed Aboulenein Editing by Marguerita ChoyOur Standards: The Thomson Reuters Trust Principles.

Persons: Lagevrio, Ahmed Aboulenein, Marguerita Choy Organizations: U.S, Pfizer, Paxlovid, U.S . Department of Health, Human Services, Thomson Locations: U.S

WASHINGTON (AP) — The COVID-19 treatments millions of Americans have taken for free from the federal government will enter the private market next week with a hefty price tag. Pharmaceutical giant Pfizer is setting the price for a five-day treatment of Paxlovid at $1,390, but Americans can still access the pills at no cost -- for now. The less commonly used COVID-19 treatment Lagevrio, manufactured by Merck, also will hit the market next week. People on private insurance may start to notice copays for the treatments once their pharmacy or doctor's office runs out of the COVID-19 treatments they received from the government. Full-year revenue for Paxlovid and Pfizer's COVID-19 vaccine, Comirnaty, is expected to be approximately $12.5 billion.

Persons: “ Pfizer, Paxlovid, coronavirus, Pfizer's, “, Tom Murphy Organizations: WASHINGTON, Pharmaceutical, Pfizer, Merck, Health, Human Services, The Department of Veterans Affairs, Department of Defense, Indian Health Service, U.S, Associated Press, and Drug Administration, Paxlovid Locations: U.S, Indianapolis

☆ Merck quarterly profit tops expectations on COVID pill surprise
▼ + stars: | 2023-10-26 | by ( Michael Erman | ) www.reuters.com time to read: +2 min

The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. Merck raised Lagevrio full-year sales forecast to $1.3 billion. Third-quarter sales of Merck's top-selling cancer immunotherapy, Keytruda, stood at $6.34 billion, surpassing analysts' average estimate of $6.22 billion. Gardasil, its vaccine to prevent cancers caused by human papillomavirus (HPV), generated sales of $2.59 billion, rising 13% but missing analysts' average estimate of $2.69 billion. The company posted sales of $15.96 billion in the reported quarter, compared to the average analyst estimate of $15.3 billion.

Persons: Brendan McDermid, Molnupiravir, Merck, Wells, Mohit Bansal, drugmaker, Michael Erman, Leroy Leo, Bill Berkrot Organizations: Merck, Co, REUTERS, Merck & Co, Pfizer's, Thomson Locations: Rahway , New Jersey, U.S, Japan, United States, EU

☆ Merck results beat expectations on strong Keytruda sales, surprise Covid drug growth
▼ + stars: | 2023-10-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Merck on Thursday reported third-quarter revenue and adjusted earnings that topped expectations on strong sales of its blockbuster cancer drug Keytruda, HPV vaccine Gardasil and surprisingly, its Covid drug Lagevrio. Merck lowered its adjusted profit guidance to $1.33 to $1.38 per share, from a previous forecast of $2.95 to $3.05 a share. But that updated outlook reflects an upfront charge of $5.5 billion, or $1.70 per share, related to the company's recent drug collaboration agreement with Daiichi Sankyo. Excluding Lagevrio, pharmaceutical sales grew 9%. The Covid antiviral treatment brought in $640 million in sales for the quarter, up 47% from the third quarter of 2022.

Persons: Merck Organizations: Merck, Prometheus Biosciences, Imago BioSciences, Kelun, Biotech, LSEG, U.S Locations: Japan, Australia

☆ US plans shift of Merck COVID treatment to commercial market
▼ + stars: | 2023-10-04 | by ( Michael Erman | ) www.reuters.com time to read: +3 min

A COVID-19 treatment pill, called molnupiravir developed by Merck & Co and Ridgeback Biotherapeutics LP is seen in this undated handout photo released by Merck & Co Inc and obtained by Reuters May 17, 2021. Merck & Co Inc/Handout via REUTERS/File photo Acquire Licensing RightsOct 4 (Reuters) - The U.S. government will stop distributing free doses of Merck & Co's (MRK.N) COVID-19 antiviral treatment molnupiravir by the middle of next month and expects it to be sold on the commercial market instead. Molnupiravir was initially hailed as a potential breakthrough when few treatment options were available but was soon eclipsed by Pfizer's (PFE.N) rival treatment Paxlovid, which had more impressive data. Merck said the study was limited and that it is confident in the clinical profile of the drug. Merck said it would have a patient assistance program for people who cannot afford the drug.

Persons: Ridgeback Biotherapeutics, Molnupiravir, Merck, Michael Erman, Bill Berkrot Organizations: Merck & Co, Merck & Co Inc, Reuters, Merck, Co Inc, REUTERS, U.S, Co's, Administration, Strategic Preparedness, U.S . Department of Health, Human Services, U.S . Food, Drug Administration, Pfizer's, Thomson Locations: U.S, United States

A study published this week linked the COVID-19 antiviral molnupiravir to new coronavirus mutations, raising questions about whether the drug could lead to the evolution of potentially concerning strains in the future. The drug works by causing mutations in the genetic information of the virus. Researchers looked at 15 million coronavirus genomes to analyze the timing and type of mutations. Study authors said the findings are important for regulators who assess the drug. “The authors assume these mutations were associated with viral spread from molnupiravir-treated patients without documented evidence of that transmission.

Persons: molnupiravir, ” Theo Sanderson, Francis Crick, Merck Organizations: Nature, Francis, Francis Crick Institute Locations: London, molnupiravir

☆ Merck Covid drug linked to virus mutations that can spread between people, new study says
▼ + stars: | 2023-09-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

A new study released Monday said Merck 's widely used antiviral Covid pill can cause mutations in the virus that occasionally spread to other people, raising questions about whether the drug has the potential to accelerate Covid's evolution. Molnupiravir works by causing mutations in Covid's genetic information, which weakens or destroys the virus and reduces the amount of Covid in the body. Researchers in the U.S. and U.K. specifically analyzed 15 million Covid genomes to see which mutations had occurred and when. Based on data at the time, a spokesperson for Merck said it didn't believe molnupiravir was likely to contribute to Covid mutations. The new study comes as Covid once again gains a stronger foothold in the U.S., primarily driven by newer strains of the virus.

Persons: Merck, molnupiravir, Theo Sanderson, Francis Crick, Covid, Merck's molnupiravir, Molnupiravir Organizations: Francis, Francis Crick Institute, Twitter, Merck, U.S . Food, Drug Administration, FDA Locations: U.S, London

☆ Fact Check-Ivermectin still not FDA-approved to treat COVID
▼ + stars: | 2023-08-30 | by ( Reuters Fact Check | ) www.reuters.com time to read: +5 min

Ivermectin is not FDA-approved for COVID treatment, but misleading posts cast the attorney’s statement as though it represented a change in the drug’s status. Referring to ivermectin, a post on messaging platform X, formerly known as Twitter, said: “The FDA now says the Nobel Prize winning drug is approved to treat COVID” (here). Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said that “FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID” (see 22:26 timestamp) and “FDA is clearly acknowledging that doctors have the authority to prescribe human ivermectin to treat COVID” (see 31:30 timestamp). “In general, off-label uses have evidence for efficacy and safety that is less than that required to have an indication FDA-approved. Ivermectin is not FDA-approved to treat COVID but the agency does not prohibit physicians from prescribing the drug off-label.

Persons: ivermectin, Ivermectin, COVID, Ashley Cheung Honold, Randall Stafford, ”, ” Stafford, “, Stafford, Ryan Abbot, ” Abbot, Read Organizations: U.S . Food, Drug Administration, FDA, Twitter, Facebook, U.S ., Appeals, Fifth Circuit, Department of Health & Human, COVID, YouTube, Justice, Stanford School of Medicine, University of Surrey, University of California, al, “, Reuters Locations: Los Angeles, Apter

☆ Merck beats quarterly sales estimate on top drugs' strength
▼ + stars: | 2023-08-01 | by ( Michael Erman | ) www.reuters.com time to read: +3 min

Companies Merck & Co Inc FollowAug 1 (Reuters) - Merck & Co (MRK.N) posted better-than-expected second-quarter sales on Tuesday on strong demand for its two top-selling products, cancer immunotherapy Keytruda and human papillomavirus (HPV) vaccine Gardasil. Shares of Merck rose about 2% at $108.45 in premarket trading after the company also raised its full-year revenue forecast. Merck said Keytruda sales for the quarter jumped 19% to $6.3 billion, surpassing analysts' average estimate of $5.9 billion. Sales of Gardasil, which prevents cancers caused by HPV, surged 47% to $2.5 billion, also well above Wall Street estimates of $2.1 billion. Merck said it now expects full-year sales of $58.6 to $59.6 billion, up from its prior view of $57.7 billion to $58.9 billion.

Persons: Merck, Rob Davis, Davis, Keytruda, Cantor Fitzgerald, Louise Chen, Prometheus, drugmaker, Michael Erman, Leroy Leo, Bill Berkrot Organizations: Merck, Co, Merck & Co, Merck's, Prometheus Biosciences, Analysts, Prometheus, Thomson Locations: United States, China, U.S, New York, Bengaluru

☆ Merck earnings better-than-expected on Keytruda, Gardasil strength
▼ + stars: | 2023-04-27 | by ( ) www.reuters.com time to read: +2 min

April 27 (Reuters) - Drugmaker Merck & Co on Thursday posted better-than-expected first-quarter results on the strength of its blockbuster cancer immunotherapy Keytruda and human papillomavirus (HPV) vaccine Gardasil. Sales of Keytruda rose 20% to $5.8 billion in the quarter, topping the average analyst forecast of $5.6 billion. Gardasil sales rose 35% to $2 billion, beating analyst estimates of $1.7 billion. It forecast 2023 sales of $57.7 billion to $58.9 billion, up from its previous forecast of $57.2 billion to $58.7 billion. The company reported nearly $21 billion in Keytruda sales last year.

☆ EU regulator recommends against approval for Merck's COVID pill for adults
▼ + stars: | 2023-02-24 | by ( ) www.reuters.com time to read: +1 min

Companies Merck & Co Inc FollowFeb 24 (Reuters) - The European Union's drug regulator said on Friday its Committee for Medicinal Products for Human Use has advised against market authorisation of the COVID-19 pill from Merck & Co Inc (MRK.N) for treatment in adults. Merck and its partner Ridgeback Biotherapeutics said they will appeal the decision and request a re-examination of the committee's opinion. "The CHMP's recommendation does not reflect the compelling data" from one of the company's late-stage trial and real-world studies, Dean Li, head of Merck's research division, said. In December, a large study had shown that the drug sped up recovery but did not reduce hospitalisation or death rate in higher-risk vaccinated adults. The regulator's recommendation against Merck's COVID-19 pill comes days after the company said Lagevrio was not effective at cutting the risk of coronavirus infections in people living with someone infected with the virus.

☆ Merck's COVID pill fails to prevent infection among household members
▼ + stars: | 2023-02-21 | by ( ) www.reuters.com time to read: +1 min

The results were similar to data from rival Pfizer Inc (PFE.N), whose COVID pill Paxlovid also failed to prevent infections among household contacts. Merck's late-stage trial enrolled over 1,500 participants, who were household contacts exposed to an individual with at least one symptom and had recently tested positive for COVID-19. Its Lagevrio pill, also known as molnupiravir, was given every 12 hours for five days and was compared with a placebo group. Participants treated with the pill were 23.6% less likely to develop COVID than those given a placebo through day 14, failing to meet the main goal of the trial, Merck said. Pfizer's Paxlovid and Merck's Lagevrio pills were given emergency use authorization in Dec. 2021 for patients with mild-to-moderate COVID that tested positive for the virus, and who were at risk of progressing to severe COVID.

"When you think about traditional drug and vaccine development and longevity of sales, it's usually much more spread out," Morningstar analyst Damien Conover said. The sudden inflow of revenue should prod companies to strike deals and link up with new partners, he said. Vaccine maker Moderna also expects 2023 revenue to fall sharply. The company's only product - its messenger RNA COVID vaccine - pulled in around $18.4 billion in 2022. Eli Lilly and Co (LLY.N) made $2 billion in 2022 from monoclonal antibody COVID treatments and is not expecting any revenue from the business in 2023.

☆ Merck fourth quarter tops expectations on strong COVID pill sales
▼ + stars: | 2023-02-02 | by ( Michael Erman | ) www.reuters.com time to read: +2 min

Feb 2 (Reuters) - Merck & Co (MRK.N) on Thursday reported higher-than-expected fourth-quarter earnings on strong sales of its COVID-19 antiviral pill molnupiravir in Asia. The U.S. drugmaker said its sales in the quarter were $13.83 billion, up from $13.52 billion a year earlier. Analysts had previously forecast around $825 million for 2023 molnupiravir sales. Pfizer (PFE.N) reported sales of around $18.9 billion for its antiviral treatment Paxlovid in 2022 and forecast 2023 sales of around $8 billion. The drugmaker forecast adjusted 2023 earnings of $6.80 to $6.95 a share on sales of $57.2 billion to $58.7 billion.

☆ U.S. FDA removes COVID test requirements for Pfizer, Merck pills
▼ + stars: | 2023-02-01 | by ( ) www.reuters.com time to read: +1 min

[1/2] Pfizer logo is seen in this illustration taken, May 1, 2022. REUTERS/Dado Ruvic/IllustrationFeb 1 (Reuters) - The U.S. Food and Drug Administration (FDA) on Wednesday removed the need for a positive test for COVID-19 treatments from Pfizer Inc (PFE.N) and Merck & Co Inc (MRK.N). Pfizer's Paxlovid and Merck's Lagevrio pills were given emergency use authorizations in Dec. 2021 for patients with mild-to-moderate COVID who tested positive for the virus, and who were at risk of progressing to severe COVID. Still, the FDA said the patients should have a current diagnosis of mild-to-moderate COVID infection. Reporting by Raghav Mahobe in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

☆ China’s Shortage of Antivirals Puts Vulnerable People at Risk
▼ + stars: | 2023-01-13 | by ( Raffaele Huang | Clarence Leong | ) www.wsj.com time to read: 1 min

SINGAPORE—China is struggling with shortages of lifesaving antivirals more than a month after its government made an abrupt U-turn on its zero-Covid policies, leaving hospitals and drugmakers unprepared for the rapid rise in cases. Many people in China are hunting for antiviral treatments such as Pfizer Inc.’s Paxlovid and Merck & Co.’s Lagevrio, also known as molnupiravir, which have been shown to suppress the ability of the virus to reproduce when taken soon after a patient gets infected.

☆ FDA pulls U.S. authorization for Eli Lilly's COVID drug bebtelovimab
▼ + stars: | 2022-11-30 | by ( ) www.reuters.com time to read: +1 min

Nov 30 (Reuters) - Eli Lilly and Co's COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron. Wednesday's announcement takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer Inc's (PFE.N) antiviral drug Paxlovid, Merck's (MRK.N) Lagevrio and Gilead Sciences' (GILD.O) Veklury as treatments for the disease, besides convalescent plasma for some patients. AstraZeneca Plc's monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people. The drug, which was discovered by Abcellera (ABCL.O) and commercialized by Eli Lilly, received an authorization from the FDA in February. BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last two months, surpassing Omicron's BA.5 sub-variant, which had driven cases earlier in the year.

☆ Japan Approves First Homegrown Covid-19 Antiviral Pill
▼ + stars: | 2022-11-22 | by ( Megumi Fujikawa | ) www.wsj.com time to read: 1 min

TOKYO—Japan approved an antiviral pill from Shionogi & Co. to treat Covid-19 after the company provided new data to show the drug’s efficacy. The treatment is the first locally developed alternative to Pfizer Inc.’s Paxlovid and Merck & Co.’s Lagevrio, which have been authorized for emergency use in Japan. Shionogi aims to win approval from the Food and Drug Administration for its pill in the U.S.

☆ As Covid cases tick up, here are latest CDC guidelines for testing and isolation
▼ + stars: | 2022-11-07 | by ( Aria Bendix | Aria Bendix Is The Breaking Health Reporter For Nbc News Digital. | ) www.nbcnews.com time to read: +4 min

Guidelines from the Centers for Disease Control and Prevention about masking, testing and isolation haven't changed much since the CDC last updated its recommendations in August. When to wear a maskSince February, the CDC has based masking guidelines on three metrics: new Covid cases, hospital capacity and hospital admissions. The Food and Drug Administration recommends that people with a known exposure who test negative take a second test 48 hours later. for at least five days after your positive test (details about when to leave isolation can be found below). If you continue to test positive beyond day 10, the CDC recommends you continue masking.

☆ Merck third-quarter earnings climb, lifts full-year outlook
▼ + stars: | 2022-10-27 | by ( Michael Erman | ) www.reuters.com time to read: +1 min

Oct 27 (Reuters) - Merck & Co (MRK.N) on Thursday posted better-than-expected third-quarter sales and earnings on a strong performance by its blockbuster cancer immunotherapy drug Keytruda and human papillomavirus vaccine Gardasil. The drugmaker also raised its full-year sales and earnings forecasts despite headwinds created by the weak euro and pound. Third-quarter sales climbed 14% to $15.0 billion, ahead of a Refinitiv consensus estimate of $14.1 billion. Merck now expects full-year sales between $58.5 billion and $59 billion, up from its previous range of $57.5 billion to $58.5 billion. It exects full-year profit in the range of $7.32 to $7.37 per share.

☆ Merck agrees to allow Sinopharm to sell molnupiravir COVID drug in China
▼ + stars: | 2022-09-28 | by ( ) www.reuters.com time to read: +1 min

NEW YORK, Sept 28 (Reuters) - Drugmaker Merck & Co (MRK.N) said on Wednesday that it agreed to allow China's Sinopharm (1099.HK) to distribute and import its COVID-19 antiviral molnupiravir in China if the drug is approved for use there. The drugmaker said in a statement that it reached a cooperation framework agreement with Sinopharm that grants the Chinese company distribution and exclusive import rights of the medicine in the China mainland market. Merck also said it will allow China National Biotec Group, an affiliate of Sinopharm, to make the drug in China and has agreed to transfer technology to help with that production. Molnupiravir is sold under the brand name Lagevrio in the U.S. Merck developed the pill - and shares the profits equally - with partner Ridgeback Biotherapeutics. Register now for FREE unlimited access to Reuters.com RegisterReporting by Michael Erman; editing by Jonathan OatisOur Standards: The Thomson Reuters Trust Principles.

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