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Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 ‘cure’ over safety concern

By Michael Erman and Carl O’Donnell

(Reuters) – Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by U.S. President Donald Trump has been paused because of a safety concern.

Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc that he received for his COVID-19, as tantamount to a cure in a video he posted last week.

The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill. J&J said it does not yet know if that person was given the vaccine or a placebo.

AstraZeneca Plc’s U.S. trial for its experimental COVID-19 vaccine has also been on hold for over a month after a volunteer in its UK study fell ill. Trials of that vaccine resumed in other regions after a brief halt.

Lilly said earlier this month it was applying for emergency use authorization (EUA) for the antibody drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial.

It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem. Because of the urgent need for drugs and vaccines to tackle a pandemic that has claimed over 1 million lives worldwide – and the speed with which they are being developed – these trials have come under intense scrutiny.

“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” Lilly spokeswoman Molly McCully said in an emailed statement. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The Indianapolis-based drugmaker did not comment on the implications for the paused trial, called ACTIV-3, which is testing the treatment on COVID-19 patients who require hospitalization, or on its other ongoing trials. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration and the National Institutes of Health did not immediately reply to requests for comment.

Lilly began its ACTIV-3 trial in August and is aiming to recruit 10,000 patients primarily in the United States.

The trial compares patients who receive its antibody drug plus Gilead Sciences Inc’s antiviral drug remdesivir with those who receive remdesivir alone.

Lilly sought the EUA from U.S. regulators after publishing data in September showing LY-CoV555 helped cut hospitalization and emergency room visits for COVID-19 patients. The treatment is being developed with Canadian biotech AbCellera.

Lilly shares closed nearly 3%.

(Reporting by Michael Erman and Carl O’Donnell in New York; Additional reporting by Deena Beasley in Los Angeles; Editing by Bill Berkrot)

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An ambassador and trained facilitator under Eco Femme (a social enterprise working towards menstrual health in south India), Sanjina is also an active member of the MHM Collective- India and Menstrual Health Alliance- India. She has conducted Menstrual Health sessions in multiple government schools adopted by Rotary District 3240 as part of their WinS project in rural Bengal. She has also delivered training of trainers on SRHR, gender, sexuality and Menstruation for Tomorrow’s Foundation, Vikramshila Education Resource Society, Nirdhan trust and Micro Finance, Tollygunj Women In Need, Paint It Red in Kolkata.

Now as an MH Fellow with YKA, she’s expanding her impressive scope of work further by launching a campaign to facilitate the process of ensuring better menstrual health and SRH services for women residing in correctional homes in West Bengal. The campaign will entail an independent study to take stalk of the present conditions of MHM in correctional homes across the state and use its findings to build public support and political will to take the necessary action.

Saurabh has been associated with YKA as a user and has consistently been writing on the issue MHM and its intersectionality with other issues in the society. Now as an MHM Fellow with YKA, he’s launched the Right to Period campaign, which aims to ensure proper execution of MHM guidelines in Delhi’s schools.

The long-term aim of the campaign is to develop an open culture where menstruation is not treated as a taboo. The campaign also seeks to hold the schools accountable for their responsibilities as an important component in the implementation of MHM policies by making adequate sanitation infrastructure and knowledge of MHM available in school premises.

Read more about his campaign.

Harshita is a psychologist and works to support people with mental health issues, particularly adolescents who are survivors of violence. Associated with the Azadi Foundation in UP, Harshita became an MHM Fellow with YKA, with the aim of promoting better menstrual health.

Her campaign #MeriMarzi aims to promote menstrual health and wellness, hygiene and facilities for female sex workers in UP. She says, “Knowledge about natural body processes is a very basic human right. And for individuals whose occupation is providing sexual services, it becomes even more important.”

Meri Marzi aims

Bill Gates says Trump’s coronavirus treatment won’t work for everyone, shouldn’t be called ‘cure’

Microsoft co-founder and billionaire philanthropist Bill Gates said Sunday that the Regeneron antibody cocktail administered to President Trump to treat a case of COVID-19 shouldn’t be referred to as a “cure.”

“The word ‘cure’ is inappropriate because it doesn’t work for everyone,” Gates told NBC’s “Meet the Press.” “But yes, of all the therapeutics, this is the most promising.”

Although an effective vaccine is an ultimate goal for putting an end to the pandemic, Gates noted that monoclonal antibodies allow for treatment that doesn’t require admission to a high percentage of the population.

“With the monoclonal antibodies, it’s only once somebody tests positive, show symptoms and they’re old enough they’re at risk,” Gates said. “That’s the target for this therapeutic.”

He added that if the monoclonal antibody treatments can be approved for an emergency use authorization in a timely manner, they will “save more lives than the vaccine will,” particularly if given in low doses.

“The president got eight grams and we’re trialing things that are down at more like 0.7 grams, and 0.3 grams,” Gates said. “Of course, that changes the cost and capacity a lot but that’s also unproven at this point, but it’s important that we explore.”

REGENERON CEO SAYS PRESIDENT TRUMP’S ANTIBODY COCKTAIL TREATMENT IS ‘CASE REPORT’

Gates is optimistic that antibody treatments, including those developed by Regeneron and Eli Lilly, could potentially earn an emergency use authorization within the next few months, but warned against the president’s recent push for the regulators to accelerate the approval timeline. 

“You don’t want politicians saying something should be approved because it’s wrong to think of political pressure as needing to be appropriate in these cases,” he said.

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REGN REGENERON PHARMACEUTICALS INC. 602.07 +2.19 +0.37%
LLY ELI LILLY & COMPANY 156.88 +3.38 +2.20%

As for vaccines, Gates said the majority of vaccines will likely get emergency use authorizations by early next year, with Pfizer and BioNTech’s vaccine potentially being an exception with a possible authorization by the end of this year.

“The phase three data is the key thing, particularly for the safety, making sure we’re not seeing side effects. So the tool is ramping up and, over the course of the first half of the year, those volumes will get to the point where we really will be asking Americans to, you know, step forward,” Gates said. “The effectiveness could range, you know, could be as low as 50% or as high as 80 [percent] or 90% and, different of the vaccines, some will fail completely and others will hit a very high bar. But we don’t know yet.”

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He added that almost all of the vaccines will

Bill Gates on Trump virus treatment: The word ‘cure’ is inappropriate because it won’t work for everyone

Microsoft founder and philanthropist Bill Gates said Sunday that the monoclonal antibodies treatment President TrumpDonald John TrumpNorth Korea unveils large intercontinental ballistic missile at military parade Trump no longer considered a risk to transmit COVID-19, doctor says New ad from Trump campaign features Fauci MORE received for his coronavirus infection is not a “cure,” but is the most promising option thus far.

“The word ‘cure’ is inappropriate because it won’t work for everyone,” Gates said Sunday on NBC’s “Meet the Press.” “But of all the therapeutics, this is the most promising.”

Gates added that the Bill & Melinda Gates Foundation has “been working with companies doing antibodies, we reserved factory capacity back in the spring, and now we’re partnered with Eli Lilly, who with Regeneron, has been the fastest to get these antibodies ready.”

“They could reduce the death rate quite a bit … adding this to the tools would be a great thing,” he added.

“They call them therapeutic, but to me it wasn’t therapeutic,” Trump said in a video he tweeted last week, five days after receiving the experimental treatment from the biotech company Regeneron

Trump said that he felt better immediately after taking the drugs.

“I call that a cure,” he said. “It’s a cure.”

Bill Gates on Sunday also warned against politicians opening large venues without social-distancing measures.

“I guess politicians will show what their value system is there,” he said. “Society should be able to have things like schooling that get a priority, vs. certain more entertainment-related things.”

“The only way we’ll get completely back to normal is by having … a vaccine that is super effective and that a lot of the people take,” he said.

Gates went on to express confidence that ” it’s likely that by early next year that several of these vaccines” currently in development “will get that emergency-use authorization.”

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Trump’s Regeneron Antibody Treatment Is Not a ‘Cure’

First, there simply are not yet enough doses in the world. Regeneron currently has enough doses for 50,000 patients. Eli Lilly, which makes a different COVID-19 monoclonal-antibody therapy that is also in clinical trials, says it will have 100,000 doses in October. To put that in context, the United States has 50,000 new cases of COVID-19 every day.

The manufacturing of monoclonal antibodies can’t just scale up on a dime to treat everyone, says Howard Levine, who leads a group of pharmaceutical manufacturing consultants at BioProcess Technology Group. The antibodies are made inside large stainless-steel tanks using genetically engineered ovary cells from hamsters. Like all living things, they can grow only so fast. The tanks are also sophisticated pieces of equipment that can take months to install, Levine says. Regeneron and Eli Lilly have already been increasing manufacturing capacity, and they expect to have 300,000 and 1 million doses, respectively, by the end of the year. The two companies have recently also filed for an emergency use authorization—a looser and faster process than formal approval by the Food and Drug Administration—-which Trump says will come soon.

The monoclonal antibodies will have to be reserved for patients who are at highest risk for eventually developing severe COVID-19. “To be able to treat thousands [of patients] is probably doable,” says Wayne Marasco, who studies monoclonal antibodies at Harvard. “Tens of thousands is pushing it, short-term.” Doctors will have to predict who might benefit the most. People who are older, have underlying conditions, or are already exhibiting serious symptoms such as low oxygen—like the president himself—would be more likely to get monoclonal antibodies.

But doctors will have to make the decision early in the course of illness, before those patients get seriously sick. Monoclonal antibodies are likely to work best when the virus is still trying to gain a foothold in the body. In general, you want to “stop the replication of a microbe—in this case, the virus—at the earliest point in time,” Cohen says. But stopping the virus depends on patients being able to get tested for COVID-19 early, receive their results quickly, and go to a hospital that stocks an experimental treatment before they really even need hospitalization. For now, monoclonal antibodies have to be administered through an IV, so they can’t be offered at pharmacies or at most doctor’s offices.

These hurdles don’t pose a problem for the president, who has the very best medical care the country has to offer. But as my colleague Olga Khazan writes, COVID-19 treatment is markedly less comprehensive and accessible for the average person. Ordinary Americans have repeatedly, in the course of this pandemic, experienced delays in testing. And when the U.S. earlier this year began allocating initially scarce doses of the antiviral drug remdesivir, which Trump has also taken, many hospitals came up empty-handed.

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Trump hails his COVID ‘cure’ as leading medical journal calls him ‘dangerously incompetent’ on pandemic






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President Trump continued to hail an experimental monoclonal antibody treatment as a “cure” for COVID-19, telling conservative radio host Rush Limbaugh in a Friday interview that it sped his recovery from the disease and was “better than a vaccine.”

“I was not in great shape, but we have a medicine that healed me, that fixed me,” Trump said of the antibody “cocktail” manufactured by Regeneron Pharmaceuticals. ”It’s a great medicine. I recovered immediately.”

Since being released from Walter Reed Medical Center on Monday, where he was treated for three days after being admitted with a high fever, chills and breathing problems, Trump has often pointed to the antibody therapy he undertook at the hospital as a “cure” for COVID-19. There is no known cure for the disease caused by exposure the coronavirus, and the FDA has not, so far, approved the drug’s use for treating COVID-19.

Just as he had done with the anti-malarial drug hydroxychloroquine, which Trump took in May as a prophylactic against COVID-19, the president didn’t hesitate describing Regeneron’s “cocktail” in the most glowing possible terms.

“We have a cure. More than just a therapeutic, have a cure,” Trump said of the antibody treatment, adding, “This is better than the vaccine.”

Both Regeneron and the drug manufacturer Eli Lilly have released limited studies showing that monoclonal antibody treatments can decrease the viral load of COVID-19 in patients who have not been hospitalized for the disease. Trump’s assertions about the drug have not been proven in any study, and he received other drugs, including Remdesivir and the steroid dexamethasone, since testing positive for COVID-19 on Thursday, Oct. 1.

On Tuesday, Trump voiced his frustration with the Food and Drug Administration for requiring drug manufacturers to follow safety protocols that will slow the availability of a vaccine until after the Nov. 3 election.

Perhaps the central issue in the presidential election is Trump’s handling of the coronavirus pandemic, and during his rambling two-hour phone call with Limbaugh, the president again complained about not receiving enough praise for his administration’s efforts to slow the spread of the virus.

“We’ve done such a good job on the pandemic. We get zero credit,” Trump said.



a man wearing a suit and tie: President Trump arrives at the White House wearing a facemask upon his return from Walter Reed Medical Center on October 5, 2020. (Photo by NICHOLAS KAMM/AFP via Getty Images)


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President Trump arrives at the White House wearing a facemask upon his return from Walter Reed Medical Center on October 5, 2020. (Photo by NICHOLAS KAMM/AFP via Getty Images)

As of Friday afternoon, at least 7.6 million Americans had tested positive and at least 213,158 had died from COVID-19, far more than in any other country.

On Thursday, the New England Journal of Medicine broke precedent and for the first time in its history published an editorial calling for a president to be voted out of office. The editors disagreed that Trump did “such a good

The President Who Cried ‘Cure’

With hydroxychloroquine a bust and vaccines not coming until after the election, President Donald Trump is touting a new silver bullet against COVID-19: monoclonal antibodies. “They call them therapeutic, but to me it wasn’t therapeutic,” he said in a video he tweeted on Wednesday, five days after receiving the experimental treatment from the biotech company Regeneron. He claimed that he felt better immediately. “I call that a cure,” he said. “It’s a cure,” he said again, defying whoever might have told him to please just say “therapeutic” instead.



diagram


© Shutterstock / The Atlantic


Preliminary and still-unpublished data from small studies suggest that monoclonal antibodies, which are lab-grown versions of antibodies the immune system naturally makes to fight pathogens, are indeed promising. Although Trump claims to be on the mend from COVID-19, it’s impossible to conclude from his case alone that the treatment is a “cure,” especially given that he got a “kitchen sink” of treatments. “No one ever got the drugs he got before, in the sequence he got them,” says Myron Cohen, an infectious-disease researcher at the University of North Carolina who is studying monoclonal antibodies in clinical trials against COVID-19.

The president is only one data point. Clinical trials need thousands of data points to determine whether a treatment works, and his endorsement could ironically make it harder to recruit patients for the trials. In hyping a treatment without the data proving that it works and without the groundwork for deploying it “immediately,” as Trump said yesterday he wants to do, he is breezing right past the scientific and logistical challenges still ahead. Trump might have gotten antibodies immediately, but most Americans won’t.

[Read: Vaccine chaos is looming]

First, there simply are not yet enough doses in the world. Regeneron currently has enough doses for 50,000 patients. Eli Lilly, which makes a different COVID-19 monoclonal-antibody therapy that is also in clinical trials, says it will have 100,000 doses in October. To put that in context, the United States has 50,000 new cases of COVID-19 every day.

The manufacturing of monoclonal antibodies can’t just scale up on a dime to treat everyone, says Howard Levine, who leads a group of pharmaceutical manufacturing consultants at BioProcess Technology Group. The antibodies are made inside large stainless-steel tanks using genetically engineered ovary cells from hamsters. Like all living things, they can grow only so fast. The tanks are also sophisticated pieces of equipment that can take months to install, Levine says. Regeneron and Eli Lilly have already been increasing manufacturing capacity, and they expect to have 300,000 and 1 million doses, respectively, by the end of the year. The two companies have recently also filed for an emergency use authorization—a looser and faster process than formal approval by the Food and Drug Administration—-which Trump says will come soon.

The monoclonal antibodies will have to be reserved for patients who are at highest risk for eventually developing severe COVID-19. “To be able to treat thousands [of patients] is

COVID drug Trump touted as a “cure” was developed using cells derived from aborted fetal tissue

The antibody cocktail that President Trump received for his COVID-19 infection and touted on Wednesday evening as a “cure” for the deadly virus was developed using cells derived from aborted fetal tissue, a practice the White House and anti-abortion rights groups oppose.

Last week, Mr. Trump received Regeneron Pharmaceuticals’ cocktail of monoclonal antibodies, an experimental therapeutic for coronavirus that is still undergoing testing and is not FDA approved. In a nearly five-minute video posted to Twitter on Wednesday, the president lauded its effects, calling it “the key.”

“I think this was a blessing from God that I caught [the virus], I think it was a blessing in disguise,” Mr. Trump said in the video. “I caught it, I heard about this drug, I said, ‘Let me take it’ … and it was incredible the way it worked.”

But the way in which the antibody cocktail was developed is at odds with the Trump administration’s position on stem cell research. The drug’s potency was tested in a lab using HEK 293T cells, a cell line originally derived from the kidney tissue of a fetus aborted in the Netherlands in the 1970s, said a spokesperson for Regeneron in an email to CBS News on Thursday. The cells “were used in testing the antibody candidates’ ability to neutralize the virus” and helped researchers “determine the ‘best’ two antibodies, which now make up the REGN-COV2 cocktail,” the spokesperson said.  

There is no fetal tissue present in the final product.

Remdesivir, an antiviral drug Mr. Trump received, also was tested using the HEK 293T cells.

Last year, the Trump administration said it would no longer support long-standing funding for medical research by government scientists using human fetal tissue, a move that countered advice from physicians and researchers. The decision was seen as a major victory for anti-abortion rights groups.

Because the fetal cells used in developing Regeneron’s antibody cocktail were originally derived from an abortion prior to the funding ban, a White House official told CBS News on Thursday that the therapeutic wasn’t in violation of the administration’s new policy.

“The Administration’s policy on the use of human fetal tissue from elective abortions in research specifically excluded ‘already-established (as of June 5, 2019) human fetal cell lines,” the official said. “Thus, a product made using extant cell lines that existed before June 5, 2019 would not implicate the Administration’s policy.”

Anti-abortion groups, which generally oppose the use of fetal tissue in pharmaceutical research, did not raise issue with the therapeutics used and promoted by the president.

“The president was not given any medicines to treat COVID-19 that involved the destruction of human life,” wrote David Prentice, Ph.D., and Tara Sander Lee, Ph.D., of the Charlotte Lozier Institute, the research arm of the anti-abortion rights political group the Susan B. Anthony List, in a statement emailed to CBS News Wednesday afternoon. “No human embryonic stem cells or human fetal tissue were used to produce the treatments President Trump received – period.”

The researchers did not

Trump politicizes promising coronavirus antibody treatments, erroneously calling them a ‘cure’

Trump also claimed in the videos he had granted the drugs an emergency use authorization (EUA), a designation that would make the medicines more broadly available. But the companies said they have submitted the requests to the Food and Drug Administration — a process that the agency has repeatedly tried to assure the public is based on science and free of political interference.

“We’re going to make them available immediately, we have an emergency use authorization that I want to get signed immediately,” Trump said in the video posted Thursday afternoon.

Experts said that by inserting himself and his own recovery story into an area of ongoing medical research, Trump risks disappointing and confusing the American public with a hopeful anecdote that may not reflect how the drug works for others or how broadly it will become available when it is approved, which he also promised would be free.

“The fundamental problem with monoclonal antibodies is there’s not enough worldwide capacity to produce enough of them to have a real impact on the disease,” said Ezekiel Emanuel, a health policy expert who is advising the campaign of Joe Biden. “Yes, they might be great, but for a small number of patients.”

The president also said in the video that people in hospitals should receive the drugs, but the data so far supports using them in people with mild or moderate illness who are recently diagnosed. Early data from ongoing studies have shown evidence the drugs reduce symptoms over days, knock back the virus by reducing levels in the body and may cut down the need for further medical visits. That data is considered very promising, but not definite evidence of a cure.

Trump’s endorsement of monoclonal antibodies comes as the authorization of a coronavirus vaccine before Election Day appears increasingly unlikely. Such an okay had loomed as a potential “October surprise” that some believed could alter the course of the election with the prospect of a quick return to normalcy. An influential medical journal argued in an editorial Wednesday that the Trump administration’s handling of the pandemic took “a crisis and turned it into a tragedy,” so the antibody drugs could offer a rare victory.

Trump said in one video that the therapies were “more important” than the vaccine, the same day that both companies disclosed that they had filed with regulators for emergency authorization to use the drugs in some patients. On Fox Business on Thursday morning, he called the Regeneron drug “a gift from heaven.”

Both the Regeneron and Eli Lilly drugs are being tested in clinical trials, and no one knows if the former helped Trump recover, whether it did so in addition to all the other treatments he received or whether he would have recovered on his own as part of the natural course of the disease.

Several experts said that Trump touting a drug as a cure will make it even harder to persuade patients to participate in ongoing clinical trials where they will have

Covid-19 Live Updates: Treatment That Trump Called a ‘Cure’ Was Tested With Cells Derived From Fetal Tissue

Here’s what you need to know:

Credit…Doug Mills/The New York Times

The antibody cocktail for Covid-19 that President Trump touted on Wednesday afternoon was developed with cells originally derived from fetal tissue, a practice that the president had repeatedly condemned.

In June 2019, the Trump administration suspended federal funding for most new scientific research involving fetal tissue derived from abortions.

“Promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration,” the Department of Health and Human Services said in a prepared statement.

“Intramural research that requires new acquisition of fetal tissue from elective abortions will not be conducted,” the statement added.

Mr. Trump last week received Regeneron’s cocktail of monoclonal antibodies — essentially, antibodies synthesized in living cells and administered to help the body fight off the infection.

To develop the antibodies, Regeneron relied on 293T, a human cell line once derived from fetal tissue. At least two companies racing to produce vaccines against the coronavirus, Moderna and AstraZeneca, also are using the cell line.

Remdesivir, an antiviral drug Mr. Trump received, also was tested using these cells.

“293Ts were used in testing the antibodies’ ability to neutralize the virus,” said Alexandra Bowie, a spokeswoman for Regeneron. “They weren’t used in any other way, and fetal tissue was not used in the research.”

In a video released Wednesday, Mr. Trump praised Regeneron’s treatment, calling it a “cure” for Covid-19 and promising to provide it free to any patient who needed it. The company said on Wednesday that it had applied to the Food and Drug Administration for emergency use authorization.

Scientists noted that the trials of the antibody cocktail are far from complete, and that Mr. Trump is taking a variety of drugs that may have explained why he said he felt better.

The White House did not immediately respond to a request for comment.

In July, the International Society for Stem Cell Research sent a letter to the Human Fetal Tissue Research Ethics Advisory Board at the National Institutes of Health, urging the board to allow fetal tissue to be used to develop treatments for Covid-19 and for other diseases.

“Fetal tissue has unique and valuable properties that often cannot be replaced by other cell types,” the letter said.

In August, the board rejected 13 of the 14 proposals involving fetal tissue. The approved proposal relied on tissue that had already been acquired.

Credit…Anna Moneymaker for The New York Times

Senator Mitch McConnell, Republican of Kentucky and the majority leader, said on Thursday that he had been avoiding the White House since midsummer because of concerns that officials there were not taking proper precautions to guard