MERCK

Potential carcinogens: Januvia is a drug that contains sitagliptin and is used by Type 2 diabetes patients to curb high blood sugar levels. (Daniel Acker/Bloomberg via Getty Images)Traces of a potential carcinogen have been found in samples of a diabetes drug produced by Merck, according to the U.S. Food & Drug Administration. >> Read more trending newsSitagliptin, produced by Merck, is used by millions of people with Type 2 diabetes, The New York Times reported. The drug is used by diabetes patients to keep high blood sugar levels in check. The FDA said that traces of a potential carcinogen had been found in samples of a popular diabetes drug produced by Merck and used by millions of people, the latest instance in which impurities were detected in top-selling pharmaceutical products.

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It was a small trial, just 18 rectal cancer patients, every one of whom took the same drug. But the results were astonishing. The cancer vanished in every single patient, undetectable by physical exam; endoscopy; positron emission tomography, or PET scans; or MRI scans. Dr. Luis A. Diaz Jr. of Memorial Sloan Kettering Cancer Center, an author of a paper published Sunday in the New England Journal of Medicine describing the results, which were sponsored by drug company GlaxoSmithKline, said he kn

The antiviral drug is prescribed to those at risk of severe disease. It's been credited with reducing hospitalizations. But then there's the "Paxlovid rebound."

Merck soundly beat Wall Street estimates for its top and bottom lines, reporting earnings of $2.14 per share on $15.9 billion in revenue.

Virus Outbreak Treatment Explainer FILE - In this photo provided by Pfizer, a technician handles one of the company's COVID-19 Paxlovid pills. COVID-19 patients have two new treatment options that can be taken at home. But that convenience comes with a catch: The pills have to be taken as soon as possible once symptoms appear. (Pfizer via AP, File) (Uncredited)Newly infected COVID-19 patients have two treatment options that can be taken at home. But that convenience comes with a catch: The pills have to be taken as soon as possible once symptoms appear.

COVID-19 patients have two treatment options that can be taken at home.

Merck plans to submit the data on early stage lung cancer to the FDA as soon as possible.

Virus Outbreak Pfizer In this photo provided by Pfizer, a lab technician visually inspects Paxlovid tablet samples in Freiburg, Germany in December 2021. (Pfizer via AP) (thomas hansmann.fotograf)Pfizer’s new COVID-19 treatment came with a catch when it debuted late last year: Supplies were limited, and it can take months to make the tablets. White House coronavirus response coordinator Jeff Zients said Wednesday that the government will have 1 million treatment courses available this month. Pfizer Chief Global Supply Officer Mike McDermott says there is “an ample amount" of Paxlovid available for high-risk patients who need it. Paxlovid production involves more than 20 different sites in over 10 countries.

Pfizer’s new COVID-19 treatment came with a catch when it debuted late last year: It can take months to make the tablets.

CEO Rob Davis said Merck is on track to fulfill its commitment in the coming days of delivering 3.1 million courses of its Covid treatment pill to the U.S.

GENEVA — (AP) — A U.N.-backed organization announced Thursday that it has signed agreements with more than two dozen generic drug makers to produce versions of Merck's COVID-19 pill to supply 105 developing countries. The Medicines Patent Pool said the deals would allow drug companies to make both the raw ingredients for molnupiravir and the finished product itself. “This is a critical step toward ensuring global access to an urgently needed COVID-19 treatment," Charles Gore, executive director of the Medicines Patent Pool, said. The group said 27 generic drug manufacturers in 11 countries, including Bangladesh, China, Egypt, Vietnam, Kenya and South Africa, would soon start producing Merck's pill. It would also bolster a two-pronged approach to the pandemic: treatment by way of medication and prevention, primarily through vaccinations.

A U.N.-backed group says it has signed agreements with more than two dozen generic drug makers to produce versions of Merck’s coronavirus pill to supply 105 developing countries.

Experts fear that despite generic versions of the drug already available, pills produced by Pfizer and Merck could end up largely bought up by rich countries.

The pills are being carefully rationed, reserved for the highest-risk patients.

The pills are being carefully rationed, reserved for the highest-risk patients.

They are the first COVID-19 treatments patients can take at home, and thus could reduce the burden on hospitals. But final testing showed it was far less effective than Pfizer’s pill and carried significant risks, including the potential for birth defects when taken by pregnant women. Since last month, the government has sent states enough Pfizer pills to treat 164,000 people, allocating them by population. While fewer COVID-19 patients now require intensive care, the surge is pushing hospitals to the breaking point. Considering that threat, Pfizer’s pill arrived just in time, Schrank said.

Two brand-new COVID-19 pills that were supposed to be an important weapon against the pandemic in the U.S. are in short supply and have played little role in the fight against the omicron wave of infections.

Virus Outbreak Treatment Explainer This image provided by Pfizer in October 2021 shows the company's COVID-19 Paxlovid pills. But that convenience comes with a catch: The pills have to be taken as soon as possible once symptoms appear. But that convenience comes with a catch: The pills have to be taken as soon as possible once symptoms appear. The antiviral pills aren't for everyone who gets a positive test. The antiviral pills aren't authorized for people hospitalized with COVID-19.

Newly infected COVID-19 patients have two new treatment options that can be taken at home.

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.

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Merck The Merck logo can be seen on a stained glass panel at a Merck company building in Kenilworth, N.J. on Dec.18, 2014. (Mel Evans/AP Photo, File)The Food and Drug Administration on Thursday issued an emergency use authorization for Merck’s molnupiravir COVID-19 pill, making it the second oral antiviral treatment available in the U.S. to treat the viral infection. >> Read more trending newsFDA issued an EUA for molnupiravir for the treatment of mild-to-moderate #COVID19 in adults with positive results of direct SARS-CoV-2 viral testing. The pill was not authorized to treat people younger than 18 because of concerns over its possible impact on bone and cartilage growth. “As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness.”>> Related: Coronavirus: FDA authorizes first pill to treat COVID-19The authorization came one day after regulators issued emergency use authorization for Pfizer’s COVID-19 pill, Paxlovid, for treatment of mild-to-moderate COVID-19 in people aged 12 and older.

The Food and Drug Administration authorization comes one day after the agency cleared a competing drug from Pfizer.

The Food and Drug Administration authorization comes one day after the agency cleared a competing drug from Pfizer.

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.

In a highly anticipated decision, the Food and Drug Administration authorized Pfizer's Paxlovid as the first antiviral pill to treat COVID-19 at home.

The company announced that laboratory testing shows the drug retains its potency against the Omicron variant.

Virus Outbreak Pfizer Pill FILE - This undated image provided by Pfizer in November 2021 shows the company's COVID-19 pills. (Pfizer via AP, File) (Uncredited)WASHINGTON — (AP) — Pfizer said Tuesday that its experimental COVID-19 pill appears effective against the omicron variant. Separate laboratory testing shows the drug retains its potency against the omicron variant, the company announced, as many experts had predicted. Pfizer tested the antiviral drug against a man-made version of a key protein that omicron uses to reproduce itself. Both the Merck and Pfizer pills are expected to perform well against omicron because they don’t target the coronavirus’ spike protein, which contains most of the new variant’s mutations.

Pfizer says that its experimental COVID-19 pill appears effective against the omicron variant.

Pfizer researchers looking for a drug to treat SARS found clues that gave the company a head start in its quest for a pill to treat COVID-19, including the omicron variant.

The vote paves the way for the agency to authorize molnupiravir for emergency use in American adults.

An FDA advisory panel has backed Merck's experimental antiviral medication to treat COVID.

The vote paves the way for the agency to authorize molnupiravir for emergency use in American adults.

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.

The pharmaceutical company is seeking emergency authorization for the pill to be used in high-risk patients who could become severely ill.

In a closely watched review, an FDA panel voted 13 to 10 to recommend authorization of Merck's COVID-19 pill, though with many caveats.

An advisory committee for the U.S. Food and Drug Administration will meet Tuesday to consider recommending approval of a pill that has been shown to cut hospitalization rates for those with the COVID-19 virus. > Read more trending newsThe FDA’s Antimicrobial Drugs Advisory Committee will take up the question of whether the antiviral pill molnupiravir, made by pharmaceutical company Merck, should be approved for use in the United States. As of Tuesday, the only FDA-authorized treatments for COVID-19 patients who are not hospitalized are monoclonal antibodies. According to Merck’s data analysis, molnupiravir cuts the risk of hospitalization and death in COVID-19 patients by 30%, compared to monoclonal antibodies, which have been shown to reduce this risk in severe COVID-19 patients by 70% to 85%. Merck’s research at first showed molnupiravir cut hospitalizations with severe COVID-19 and deaths from the virus by 50%.

The regulator said the experimental antiviral pill is effective against the virus but identified several potential risks, including birth defects.

The regulator said the experimental antiviral pill is effective against the virus but identified several potential risks, including birth defects.

Federal health regulators said they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy.

The Food and Drug Administration has determined that Merck’s COVID-19 pill is effective in treating the coronavirus, but more research on potential issues is needed. There are several potential risks including possible toxicity and birth defects. If approved, Merck’s COVID-19 pill would be the first treatment that can be used at home, the AP reported. More coronavirus pandemic coverage:>> Coronavirus: How long between exposure to the virus and the start of symptoms? This tool will tell you>> How to not let coronavirus pandemic fatigue set in, battle back if it does©2021 Cox Media Group

U.S. health officials say Merck's experimental COVID-19 pill is effective but they raised questions about its safety during pregnancy.

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AMSTERDAM — (AP) — The European Medicines Agency said it has received a request from Merck to authorize its coronavirus antiviral, the first pill shown to treat COVID-19. In a statement Tuesday, the EU drug regulator said it had started evaluating molnupiravir, made by Merck and Ridgeback Biotherapeutics, and that a decision could be made within weeks on whether it might be cleared. The agency said the drug should be given as soon as possible after COVID-19 has been diagnosed and within five days of symptoms starting. The U.K. licensed molnupiravir for adults diagnosed with COVID-19 and with at least one risk factor for severe disease. Merck has said it can produce 10 million treatment courses this year, but much of that supply has already been purchased by governments worldwide.

The European Medicines Agency says it has received a request from Merck to authorize its coronavirus antiviral, the first pill shown to treat COVID-19.

The European Medicines Agency has issued emergency use advice for using Merck’s COVID-19 pill, even though the oral medicine has not yet been authorized.

Bill Gates says vaccines and antiviral drugs could get the Covid pandemic to a manageable point by summer 2022. Here's how.

Antiviral pills that treat Covid are on the way to approval. Here's what you need to know about molnupiravir from Merck and Paxlovid from Pfizer, two promising medications.

It is one of a handful of pills that have recently been shown to significantly cut hospitalizations and deaths among people infected with COVID-19.

Drugmaker is asking regulators to authorize its experimental coronavirus pill for people with mild to moderate infections.

Pfizer COVID Pill This image provided by Pfizer shows its COVID-19 pill. (Pfizer via AP) (thomas hansmann.fotograf)WASHINGTON — (AP) — Pfizer said Tuesday it is asking U.S. regulators to authorize its experimental pill for COVID-19, setting the stage for a likely launch of the promising therapy in the coming weeks. All FDA authorized treatments against COVID-19 require an IV or injection given by a health professional at a hospital or clinic. Pfizer reported earlier this month that its pill cut hospitalizations and deaths by 89% among high-risk adults who had early symptoms of COVID-19. For best results, patients need to start taking the pills within three days of symptoms, underscoring the need for speedy testing and diagnosis.

Pfizer is seeking U.S. authorization of its experimental COVID-19 treatment pill.

THE HAGUE, Netherlands — (AP) — The European Union's medicines agency on Monday began reviewing Merck's COVID-19 treatment pill so that it can swiftly advise national drug authorities in the 27-nation bloc that want to begin using it before it gets official approval. Merck's COVID-19 pill is already under review by the U.S. Food and Drug Administration after showing strong initial results. Patients with mild-to-moderate COVID-19 would take four pills of the drug twice a day for five days. In the United States, the FDA has set a public meeting later this month to review molnupiravir. That genetic activity has led some independent experts to question whether the drug could potentially cause mutations leading to birth defects or tumors.

Merck and Pfizer are pursuing emergency authorization for pills to treat COVID-19.

Top health officials sounded off before a key Senate committee about what happens next in the fight against the coronavirus.

Booster doses as well as Pfizer's new Covid pills could be a powerful combo in the fight against Covid.

Based on the strength of the trial's results, Pfizer says it will ask the FDA for emergency use authorization rather than enroll more people for clinical trials.

Pfizer says its experimental pill for COVID-19 cut rates of hospitalization and death by nearly 90% among patients with mild-to-moderate infections.

Britain has granted a conditional authorization to Merck’s coronavirus antiviral.

A new study found a cheap antidepressant reduced the need for hospitalization among high-risk adults with COVID-19.

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Drugmaker Merck says its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus.

A decline in COVID-19 cases across the United States over the past several weeks has given overwhelmed hospitals some relief.

Stocks rebounded on Wall Street Friday but still ended with their worst weekly decline since February.

U.S. regulators have approved a new pneumonia vaccine from Merck, more than a month after OK'ing an improved version of rival Pfizer’s shot.

A new study shows screening and the HPV vaccine have led to drops in cervical cancers over the last two decades in the U.S. But those gains are offset by a rise in other tumors caused by the virus.

White House aides said Biden’s first priority is ensuring that Americans are vaccinated before considering distributing doses elsewhere. AdRussia has sent millions of doses of its Sputnik V vaccine to countries around the world, even as it vaccinates its own population. Israel, which has vaccinated more than half of its population with Pfizer vaccines produced in Europe, has also attempted to use vaccine diplomacy to reward allies. Biden's purchasing strategy has come under criticism from nongovernmental organizations who have encouraged the White House to develop clear plans and thresholds for sharing vaccine with the world. So we’re not going to be ultimately safe until the world is safe,” acknowledged Biden.

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.

(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 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. It said last fall that it had started early-stage research in volunteers on potential vaccines that require only one dose. Five potential vaccines have reached late-stage testing in the United States, the final phase before a drugmaker seeks approval from regulators.

The strong result was due to sales slightly higher than a year ago, plus restrained spending. The Kenilworth, New Jersey, company on Tuesday said it’s making progress on three efforts to combat the coronavirus pandemic: two vaccines and an antiviral drug. Meanwhile, Merck is developing two experimental vaccines that only require one dose, unlike the many two-dose vaccines further along in human testing. Merck reported revenue of $12.55 billion, also easily beating analyst projections for $12.26 billion. Veterinary medicine sales jumped 9%, to $1.22 billion.