Who is eligible for new antiviral pills, monoclonal antibodies to treat COVID-19?
For COVID-19 therapies, there is limited supply and high demand, meaning it is difficult for most to access new antiviral pills and monoclonal antibodies. The window is a bit longer, 5 to 10 days, for monoclonal antibodies, more readily available. RELATED: Monoclonal antibodies even more limited as omicron overtakes delta; new antiviral pills also scarceThe antibodies, said to reduce chances of hospitalization and death by 70%, should be considered for patients who are in eligible lower risk tiers. There are three available monoclonal antibodies. “Our patients shouldn’t be counting on monoclonal antibodies,” Dr. Gordana Simeunovic, an infectious disease physician and head of Grand Rapids-based Spectrum Health’s mAbs program, said earlier this month.
mlive.comEXPLAINER: New easy-to-use COVID-19 pills come with a catch
The challenge is getting tested, getting a prescription and starting the pills in a short window. U.S. regulators authorized Pfizer's pill, Paxlovid, and Merck’s molnupiravir last week. In high-risk patients, both were shown to reduce the chances of hospitalization or death from COVID-19, although Pfizer's was much more effective.
news.yahoo.comFDA authorizes emergency use of two COVID-19 pills to treat mild to moderate COVID-19
The U.S. Food and Drug Administration on Wednesday and Thursday approved for emergency use two pills to treat mild to moderate COVID-19 when there is a high risk the disease could progress, necessitating hospitalization or causing death. They were unvaccinated adults with mild or moderate COVID-19 and chronic medical conditions or an increased risk of SARS-CoV-2 infection. RELATED: FDA advisors narrowly recommend Merck’s COVID-19 pillWith Paxlovid, patients could experience impaired sense of taste, diarrhea, high blood pressure and muscle aches, the FDA says. RELATED: Demand for monoclonal antibodies to treat COVID-19 is high, supply is low — and omicron is comingThe situation could be worsened by the rise of omicron. Michigan diner owner who defied state shutdown dies of COVID-19Feds sending emergency medical team to Mercy Health Muskegon during COVID-19 surge
mlive.comFDA authorizes Pfizer's Covid treatment pill, the first oral antiviral drug cleared during the pandemic
The Food and Drug Administration has granted emergency authorization to Pfizer's Covid treatment pill, a major milestone that promises to revolutionize the fight against the virus. Pfizer's pill is the first oral antiviral drugs authorized by the FDA that are specifically designed to fight Covid. The U.S. has purchased 10 million courses of Pfizer's treatment, Paxlovid, in a $5 billion deal. Pfizer's treatment is administered in two 150 milligram tablets along with a 100 milligram tablet of an HIV drug, ritonavir, twice daily. Merck's 800 milligram pill is taken every 12 hours for five days after symptom onset.
cnbc.comFDA advisors narrowly recommend Merck’s COVID-19 pill for authorization
Thirteen members voted in favor of recommending authorization, while the remaining 10 members voted against authorization. It was developed by New Jersey-based pharmaceutical company Merck and Ridgeback Biotherapeutics, and was used on more than 700 patients during clinical trials. Use of molnupiravir in clinical trials reduced the risk of hospitalization or death from COVID-19 by 30%, according to the company’s clinical trial data. Merck has requested emergency use authorization for the pill, which would be made available via prescription for high-risk patients with mild-to-moderate cases of COVID-19 during the first five days of illness. If granted emergency authorization, molnupiravir would be the first oral antiviral medicine available for COVID-19 in the U.S.
mlive.comFDA advisory panel narrowly endorses Merck's oral Covid treatment pill, despite reduced efficacy and safety questions
A Food and Drug Administration advisory panel on Tuesday narrowly endorsed the use of Merck and Ridgeback Biotherapeutics' oral Covid treatment pill, despite questions about the drug's effectiveness, safety and whether it would help the virus mutate into even more dangerous variants. The drug needs final approval from the FDA and Centers for Disease Control and Prevention before it's available to the public. Molnupiravir works by prompting the virus that causes Covid to mutate and produce errors inhibiting its ability to replicate and spread. Hildreth told Kartsonis that it is incumbent on Merck to estimate the likelihood of escape mutants. Pfizer is similarly seeking approval for its own oral Covid treatment pill that it said was 89% effective in preventing hospitalization and death when administered with a popular HIV drug.
cnbc.comEverything You Need to Know About Merck’s Game-Changing Covid Pill
Molnupiravir, an antiviral pill being developed by Merck & Co., has been touted as a potential game changer in the fight against Covid-19. The experimental medication was shown to reduce the risk of hospitalization or death by about half in a late-stage study of adults with mild-to-moderate cases. The promise of a drug that patients can easily get and take at home has prompted some governments to order supplies even before most regulators have decided whether to approve its use.
washingtonpost.comWhy a New Pill to Treat Covid Could Be a Game Changer: QuickTake
Molnupiravir, an antiviral pill being developed by Merck & Co., has been touted as a potential game changer in the fight against Covid-19. The experimental medication was shown to reduce the risk of hospitalization or death by about half in a late-stage study of adults with mild-to-moderate cases. The promise of a drug that patients can easily get and take at home has prompted some governments to order supplies even before most regulators have decided whether to approve its use.
washingtonpost.comThe Latest: 92% of Denver’s municipal employees vaccinated
At least 92% of Denver’s municipal employees were vaccinated against COVID-19 Friday, a day after the city’s vaccine mandate took effect in a bid to slow the spread of the virus during the fall and winter, according to a review of city compliance data.
President Biden speaks on anniversary of COVID shutdown
(AP Photo/Andrew Harnik)President Joe Biden delivered his first prime-time speech since taking office. Related: Congress OKs $1.9T virus relief bill in win for Biden, DemsEarlier Thursday, Biden signed a landmark $1.9 trillion COVID-19 relief bill. “This historic legislation is about rebuilding the backbone of this country,” Biden said as he signed the bill in the Oval Office. Biden originally planned to sign the bill on Friday, but it arrived at the White House more quickly than anticipated. Ad“We want to move as fast as possible,” tweeted White House chief of staff Ron Klain.
Watch live: President Biden addresses nation on anniversary of COVID shutdown
(AP Photo/Andrew Harnik)President Joe Biden is set to deliver his first prime-time address since taking office. Watch live at 8 p.m. Thursday:Related: Congress OKs $1.9T virus relief bill in win for Biden, DemsEarlier Thursday, Biden signed a landmark $1.9 trillion COVID-19 relief bill. “This historic legislation is about rebuilding the backbone of this country,” Biden said as he signed the bill in the Oval Office. Biden originally planned to sign the bill on Friday, but it arrived at the White House more quickly than anticipated. Ad“We want to move as fast as possible,” tweeted White House chief of staff Ron Klain.
Live stream: President Biden addresses nation on anniversary of COVID shutdown
(AP Photo/Andrew Harnik)President Joe Biden delivered his first prime-time address since taking office. This live stream has endedRelated: Congress OKs $1.9T virus relief bill in win for Biden, DemsEarlier Thursday, Biden signed a landmark $1.9 trillion COVID-19 relief bill. “This historic legislation is about rebuilding the backbone of this country,” Biden said as he signed the bill in the Oval Office. Biden originally planned to sign the bill on Friday, but it arrived at the White House more quickly than anticipated. Ad“We want to move as fast as possible,” tweeted White House chief of staff Ron Klain.
Biden holds event with Johnson & Johnson and Merck CEOs
FILE - In this March 5, 2021, file photo, President Joe Biden participates in a roundtable discussion on a coronavirus relief package in the State Dining Room of the White House in Washington. (AP Photo/Patrick Semansky, File)President Biden hosted an event with the CEOs of Johnson & Johnson and Merck Wednesday afternoon at the White House. Merck had previously been working on two of its vaccine candidates but stopped that work after early clinical trial data showed a poor immune response. The J&J vaccine can be stored in a normal refrigerator unlike the Pfizer and Moderna vaccines -- it’s not a mRNA vaccine. Johnson & Johnson CEO Alex Gorsky is a native Michigander.
Merck to help manufacture Johnson & Johnson COVID-19 vaccine
DETROIT – President Joe Biden announced that pharmaceutical giant Merck & Co. will help manufacture Johnson & Johnson’s COVID-19 vaccine. The arrangement comes after officials found out that Johnson & Johnson had fallen behind on production. Johnson & Johnson has pledged 16 million additional doses by the end of the month. READ: Michigan loosens COVID restrictions on restaurants -- here are all the detailsMichigan is also playing a role in the Johnson & Johnson vaccine. READ: Grand Rapids-based Grand River Aseptic to help manufacture J&J vaccineAdQuestions about coronavirus?
The Latest: Ontario seniors won't get AstraZeneca vaccine
The administration is invoking the Defense Production Act, a wartime measure that gives the federal government authority to direct private companies to meet the needs of the national defense, to equip two Merck facilities to produce the Johnson & Johnson vaccine. AdBiden said Johnson & Johnson will operate 24/7 to produce the vaccine. Tom Wolf said Tuesday that teachers will receive doses of the newly approved one-shot Johnson & Johnson vaccine, under a plan his administration will release. AdHe gave few details, but said he and a bipartisan legislative task force agreed that the Johnson & Johnson vaccine should be set aside for teachers and then other workers considered to be essential, but who are not included in the first vaccination phase. States are receiving 2.8 million doses of the newly approved Johnson & Johnson vaccine this week.
Longtime Merck CEO, minority advocate Ken Frazier to retire
(AP Photo/Seth Wenig, File)KENILWORTH – Longtime Merck executive Ken Frazier, whose leadership helped bring the drugmaker one of the most lucrative medicines in history and who is one of the few remaining Black CEOs of a major corporation, is retiring. Frazier, Merck’s CEO since early 2011 and an advocate for minority advancement who took on then-President Trump’s tacit support of white supremacists, will retire on June 30. He is one of the few Black CEOs at the head of a Fortune 500 company. At Merck, Frazier clashed with then-President Donald Trump over his refusal to condemn violence by the white supremacists who marched in Charlottesville, Virginia, in 2017. Share prices have more than doubled, and revenue has nearly doubled, under Frazier as CEO.
Merck ends development of two potential COVID-19 vaccines
The drugmaker will stop developing two potential COVID-19 vaccines after seeing poor results in early-stage studies. (AP Photo/Seth Wenig, File)Merck is giving up on two potential COVID-19 vaccines following poor results in early-stage studies. The company said its potential vaccines were well tolerated by patients, but they generated an inferior immune system response compared with other vaccines. Merck was developing one of the potential vaccines with France’s Pasteur Institute based on an existing measles vaccine. Five potential vaccines have reached late-stage testing in the United States, the final phase before a drugmaker seeks approval from regulators.
The Latest: Texas COVID-19 hospitalizations continue to fall
State health officials Monday reported fewer than 13,000 people were being treated for the virus in Texas hospitals, marking the seventh consecutive day of declining patient loads. Some hospitals and clinics have reported having to cancel immunization appointments because they didn’t have enough vaccine doses to distribute. A little more than half of Ochsner employees have yet to get the vaccine, officials said at a news conference Monday. Tessa Walker Linderman, co-lead of Alaska’s COVID-19 Vaccine Task Force, told reporters the state expects to learn soon what its vaccine allocation will be for February. Health officials are also worried about variants that were first reported in the United Kingdom and South Africa.
Merck sales soar but 3Q profit dips on higher spending
KENILWORTH, NJ Big jumps in sales of Merck's top two blockbuster drugs drove revenue up 15%, but higher spending across the board pushed profits down 3% in the third quarter. The quarter was dominated again by advanced cancer drug Keytruda, with sales soaring 62% to $3.07 billion, more than a quarter of Merck's $11.1 billion in revenue from prescription medicines. The maker of Januvia Type 2 diabetes pills and vaccines on Tuesday reported total revenue of $12.4 billion, including $1.12 billion in sales of veterinary medicines. Merck narrowed and raised its per-share 2019 profit forecast to between $5.12 and $5.17, up from its July forecast of $3.78 to $3.88. It also narrowed and raised its full-year forecast for sales to a range of between $46.5 billion and $47 billion, up from between $45.2 billion and $46.2 billion.