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World

An unproven Covid-19 drug is turning out to be a proven moneymaker for its manufacturer.

The United States reached a milestone, of sorts, when last week the Food and Drug Administration approved the first treatment for Covid-19: Veklury, better known by its scientific name, remdesivir.But the F.D.A.’s decision to grant the drug full approval — which means its manufacturer, Gilead Sciences, can begin marketing it broadly to doctors and patients — has puzzled several outside experts. They say that it may not deserve the agency’s stamp of approval because it is, at best, a mediocre treatment for the disease caused by the coronavirus.One large, government-run trial found that the drug shortens patients’ recovery times, but the two other studies the F.D.A. used to justify its approval — sponsored by Gilead — did not compare the treatments with a placebo, the gold standard for ev...

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Health

Gilead’s Covid-19 Drug is Mediocre. It Will Be a Blockbuster Anyway.

The United States reached a milestone, of sorts, when last week the Food and Drug Administration approved the first treatment for Covid-19.The drug is called Veklury, although most people know it by its scientific name, remdesivir.On Wednesday, its manufacturer, Gilead Sciences, said that remdesivir, which has been authorized for emergency use since the spring, had brought in $873 million in revenues so far this year and that it was the company’s second-best-selling drug in the third quarter, behind its H.I.V. drug, Biktarvy.But the F.D.A.’s decision to grant the drug full approval — which means the company can now begin broadly marketing it to doctors and patients — has puzzled several outside experts, who say that it may not deserve the agency’s stamp of approval because it is, at bes...

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Health

Pfizer C.E.O. All but Rules Out Vaccine Before Election Day

After weeks of dangling the possibility of coronavirus vaccine results by October, Pfizer’s chief executive said on Tuesday that would now be nearly impossible.The announcement, by Dr. Albert Bourla, came on the same day that Pfizer announced third-quarter earnings, and all but ruled out the possibility of early results before the presidential election next Tuesday. President Trump had long sought to tie the possibility of positive vaccine news to his own prospects for re-election.In a call with investors on Tuesday, Wall Street analysts pushed Dr. Bourla to be more specific about when the company would have early results that could show the effectiveness of its vaccine, and how much detail the company would provide. Pfizer is one of four companies with large, late-stage clinical trials...

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Science

Pfizer C.E.O. All but Rules Out Vaccine Before Election Day

After weeks of dangling the possibility of coronavirus vaccine results by October, Pfizer’s chief executive said on Tuesday that would now be nearly impossible.The announcement, by Dr. Albert Bourla, came on the same day that Pfizer announced third-quarter earnings, and all but ruled out the possibility of early results before the presidential election next Tuesday. President Trump had long sought to tie the possibility of positive vaccine news to his own prospects for re-election.In a call with investors on Tuesday, Wall Street analysts pushed Dr. Bourla to be more specific about when the company would have early results that could show the effectiveness of its vaccine, and how much detail the company would provide. Pfizer is one of four companies with large, late-stage clinical trials...

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World

Eli Lilly said its antibody treatment does not work on patients hospitalized with Covid-19.

The drug maker Eli Lilly said on Monday that its antibody treatment was ineffective on patients hospitalized with advanced Covid-19 and that a government-sponsored trial would not administer the drug to new participants.The company said that other trials of the treatment, in people who are not as sick or who have been exposed to the virus, would continue, and that it remained optimistic that the treatment could work if given early in the course of the disease.Earlier this month, Chris Christie, the former governor of New Jersey, said he had received the experimental treatment shortly after he was diagnosed with Covid-19. President Trump received a similar therapy, made by Regeneron, soon after he was infected. Both companies have applied to the Food and Drug Administration for emergency...

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Business

Experts Tell F.D.A. It Should Gather More Safety Data on Covid-19 Vaccines

Vaccine experts peppered officials at the Food and Drug Administration with a range of questions on Thursday about its guidelines for approving a coronavirus vaccine, pushing the agency on whether it should wait longer to collect more safety data and whether an emergency approval could jeopardize the outcome of the broader clinical trials.The stakes, the experts said, could not be higher. Even as a vaccine is seen as crucial to ending the pandemic, opinion polls have shown that Americans are increasingly skeptical about the products and worry that the vetting process is being rushed.“In this particular case, public trust equals success,” said Sheldon Toubman, the consumer representative on the advisory group. “Lack of trust means no success.”The meeting, which lasted all day and was bro...

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World

Promising antibody treatments will be in short supply.

Nearly two weeks ago, President Trump told Americans that they would soon be getting an antibody treatment that he had promoted, without evidence, as a “cure” for the coronavirus. Last weekend, as the country braced for another major wave of coronavirus infections, Mr. Trump’s health secretary promised such therapies were just around the corner.But these statements are misleading, at best. Even if the drugs are proven to work — still a big if — there’s little chance that they will soon be widely available. A smooth distribution of the antibody treatments will be dependent on the very same factors that have so far bedeviled the country’s response to Covid-19: fast and plentiful testing, coordination between state and federal officials, and equitable access to health care.Supply will be e...

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Health

Antibody Treatments, Though Promising, Will Be in Short Supply

Nearly two weeks ago, President Trump told Americans that they would soon be getting an antibody treatment that he had promoted, without evidence, as a “cure” for the coronavirus. This weekend, as the country braced for another major wave of coronavirus infections, Mr. Trump’s health secretary promised such therapies were just around the corner.But these statements are misleading, at best. Even if the drugs are proven to work — still a big if — there’s little chance that they will soon be widely available. A smooth distribution of the antibody treatments will be dependent on the very same factors that have so far bedeviled the country’s response to Covid-19: fast and plentiful testing, coordination between state and federal officials, and equitable access to health care.Supply will be e...

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Health

9 Drug Companies Pledge to ‘Stand With Science’ on Coronavirus Vaccines

Nine pharmaceutical companies issued a joint pledge on Tuesday that they would “stand with science” and not put forward a vaccine until it had been thoroughly vetted for safety and efficacy.The companies did not rule out seeking an emergency authorization of their vaccines, but promised that any potential coronavirus vaccine would be decided based on “large, high quality clinical trials” and that the companies would follow guidance from regulatory agencies like the Food and Drug Administration.“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved,” the companies said.President Trump has repeatedly claimed in recent weeks that a vaccine could be available before ...

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Health

Clinical Trials of Coronavirus Drugs Are Taking Longer Than Expected

At some hospitals, officials have been able to use existing facilities. In Tyler, Texas, the UT Health North Campus medical center is an old tuberculosis hospital, with rooms that use negative air pressure to prevent viruses from spreading.But in other locations, like Holy Cross Hospital in Fort Lauderdale, Fla., finding the right spot has been a struggle. Dr. Joshua Purow, who is overseeing the Eli Lilly outpatient trial at the hospital, rushed to get his site ready once he saw that infections were rising in the area.The Coronavirus Outbreak ›Frequently Asked QuestionsUpdated August 12, 2020Can I travel within the United States?Many states have travel restrictions, and lots of them are taking active measures to enforce those restrictions, like issuing fines or asking visitors to quaran...

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