Let’s Get Real About the President’s Antibody Treatment
54 years, 11 months ago

Let’s Get Real About the President’s Antibody Treatment

Wired  

The President claimed on Wednesday that he’d had a rapid “cure” from Covid-19, thanks to an experimental drug from Regeneron that’s “like, unbelievable!” Trump also said he has “emergency use authorization all set” for the treatment, and Regeneron quickly followed by requesting that approval from the US Food and Drug Administration. What’s more, the Eli Lilly trial is not designed to test effectiveness, while the Regeneron report describes only about one-quarter of the patients it would need to show whether the treatment works. A clamor for presidentially juiced drugs, and prompt approval for their emergency use by the FDA, might end up driving people away from randomized trials where they could end up receiving a placebo or “standard care.” Read all of our coronavirus coverage here. Indeed, on September 1, the National Institutes of Health challenged the FDA’s decision to authorize the emergency use of convalescent plasma by concluding there wasn’t enough evidence to make a recommendation either way.

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History of this topic

US authorises new antibody drug bebtelovimab to fight Omicron
2 years, 10 months ago

US authorises new antibody drug bebtelovimab to fight Omicron

Firstpost  

The Food and Drug Administration said it cleared the Eli Lilly drug for adults and adolescent patients with mild-to-moderate cases of COVID-19 that also works against the emerging BA.2 mutation of Omicron Washington: US health regulators have authorised a new antibody drug that targets the Omicron variant, a key step in restocking the nation’s arsenal against the latest version of …

US FDA authorises Eli Lilly's Covid-19 antibody drug to fight omicron
2 years, 10 months ago

US FDA authorises Eli Lilly's Covid-19 antibody drug to fight omicron

India Today  

US health regulators on Friday authorised a new antibody drug that targets the omicron variant, a key step in restocking the nation's arsenal against the latest version of COVID-19. It's "an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge," said Dr. Patricia Cavazzoni, FDA's drug center director. …

US authorises new antibody drug 'Eli Lilly' to fight Omicron variant
2 years, 10 months ago

US authorises new antibody drug 'Eli Lilly' to fight Omicron variant

India TV News  

US health regulators have authorised a new antibody drug that targets the omicron variant, a key step in restocking the nation's arsenal against the latest version of COVID-19. Lilly announced work on the treatment late last year after testing revealed that its previous antibody therapy was ineffective against the dominant omicron variant. It's "an important step in meeting the need …

US buys 600K doses of new COVID antibody awaiting clearance
2 years, 10 months ago

US buys 600K doses of new COVID antibody awaiting clearance

Associated Press  

WASHINGTON — Addressing diminished treatment options in the omicron wave, the Biden administration has purchased enough of a yet-to-be approved antibody drug to treat 600,000 COVID-19 patients, officials said Thursday. The new monoclonal antibody from pharmaceutical giant Eli Lilly will be shipped out to states free of charge if the Food and Drug Administration approves the company’s request for emergency …

DeSantis blasts FDA for halting drugs ineffective on omicron
2 years, 10 months ago

DeSantis blasts FDA for halting drugs ineffective on omicron

Associated Press  

TALLAHASSEE, Fla. — Florida Gov. Ron DeSantis pushed Tuesday for coronavirus patients to continue receiving antibody treatments deemed ineffective against the omicron variant, vowing to fight White House health regulators in his latest feud with President Joe Biden. At a news conference Tuesday, DeSantis referenced anecdotal cases in which people were helped by the monoclonal antibody treatments and said it …

FDA halts use of antibody drugs that don’t work vs. omicron
2 years, 11 months ago

FDA halts use of antibody drugs that don’t work vs. omicron

Associated Press  

WASHINGTON — COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they don’t work against the omicron variant that now accounts for nearly all U.S. infections, U.S. health regulators said Monday. But officials resumed distribution after complaints from Republican governors, including Florida’s Ron DeSantis, who claimed that the drugs continued to help some omicron patients. …

AstraZeneca Asks FDA to Authorise Covid Antibody Treatment
3 years, 2 months ago

AstraZeneca Asks FDA to Authorise Covid Antibody Treatment

News 18  

AstraZeneca, the Anglo-Swedish drugmaker that developed one of the first COVID-19 vaccines, has asked the U.S. Food and Drug Administration to authorise the emergency use of an antibody treatment to prevent the disease. The company said Tuesday that the treatment, known as AZD7442, would be the first long-acting antibody combination to receive an emergency use authorization for COVID-19 prevention. The …

AstraZeneca asks FDA to authorise COVID antibody treatment
3 years, 2 months ago

AstraZeneca asks FDA to authorise COVID antibody treatment

The Hindu  

AstraZeneca, the Anglo-Swedish drugmaker that developed one of the first COVID-19 vaccines, has asked the U.S. Food and Drug Administration to authorise the emergency use of an antibody treatment to prevent the disease. The company said Tuesday that the treatment, known as AZD7442, would be the first long-acting antibody combination to receive an emergency use authorization for COVID-19 prevention. The …

Swiss Pharma Giant Roche Reports Promising Results from Anti-Covid Cocktail
3 years, 9 months ago

Swiss Pharma Giant Roche Reports Promising Results from Anti-Covid Cocktail

News 18  

Swiss pharma giant Roche announced Tuesday promising results from clinical trials of an anti-Covid cocktail developed with US biotech firm Regeneron. Levi Garraway, Roche’s chief medical officer and head of global product development, said “new infections continue to rise globally with over three million reported cases last week. “This investigational antibody cocktail may offer hope as a potential new therapy …

Regeneron to stop giving placebo in Covid-19 drug trial after 'clear efficacy'
3 years, 9 months ago

Regeneron to stop giving placebo in Covid-19 drug trial after 'clear efficacy'

Hindustan Times  

Regeneron Pharmaceuticals said on Thursday that an independent panel found the company's Covid-19 antibody cocktail to have "clear clinical efficacy" in reducing the rates of hospitalization and deaths in patients. In January, the US government said it will buy 1.25 million additional doses of Regeneron Pharmaceuticals' Covid-19 antibody cocktail. Independent Data Monitoring Committee found that both 1,200mg and 2,400mg doses …

US pharmaceutical Eli Lilly's, biotech firm Regeneron's Covid-19 antibodies study data shows promising results
3 years, 10 months ago

US pharmaceutical Eli Lilly's, biotech firm Regeneron's Covid-19 antibodies study data shows promising results

Hindustan Times  

US pharmaceutical company Eli Lilly's combination of two synthetic antibodies against Covid-19 reduced hospitalizations and deaths by 70 percent in high-risk patients with recent positive tests, the company said Tuesday. "Bamlanivimab and etesevimab together have the potential to be an important treatment that significantly reduces hospitalizations and death in high-risk COVID-19 patients," Lilly's chief scientific officer Daniel Skovronsky said. - …

I got ultra-rare Regeneron to cure my COVID, Rudy Giuliani says
4 years ago

I got ultra-rare Regeneron to cure my COVID, Rudy Giuliani says

Daily Mail  

Rudy Giuliani has revealed that he was treated with a rare and in-demand experimental drug while he was hospitalized with the coronavirus – making him just the latest powerful Donald Trump associate to get special care. Giuliani, who has been heading Trump's legal effort to overturn the election results, told the New York Daily News he had in fact been …

U.S. FDA grants emergency use authorization to...
4 years, 1 month ago

U.S. FDA grants emergency use authorization to...

Daily Mail  

The FDA on Saturday issued emergency use authorization for Regeneron Pharmaceuticals Inc's COVID-19 antibody therapy, an experimental treatment given to President Donald Trump that he said helped cure him of the disease. The FDA said the monoclonal antibodies, casirivimab and imdevimab, should be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive …

FDA Grants Emergency Authorization For A 2nd COVID-19 Antibody Treatment
4 years, 1 month ago

FDA Grants Emergency Authorization For A 2nd COVID-19 Antibody Treatment

NPR  

FDA Grants Emergency Authorization For A 2nd COVID-19 Antibody Treatment Enlarge this image toggle caption Susan Walsh/AP Susan Walsh/AP One of the experimental drugs that President Trump received while he was battling the coronavirus has been approved for emergency use by the Food and Drug Administration. The drug, made by the biotech company Regeneron, is the second antibody treatment to …

FDA authorizes use of Regeneron’s antibody cocktail given to Trump to treat Covid-19
4 years, 1 month ago

FDA authorizes use of Regeneron’s antibody cocktail given to Trump to treat Covid-19

CNN  

CNN — The US Food and Drug Administration on Saturday issued an emergency use authorization for Regeneron’s antibody cocktail to treat Covid-19 in high-risk patients with mild to moderate disease. Regeneron’s chief executive officer, Dr. Leonard S. Schleifer, said in a statement that demand may initially exceed supply, “making it even more critical that federal and state governments ensure REGEN-COV2 …

FDA allows emergency use of antibody drug Trump received
4 years, 1 month ago

FDA allows emergency use of antibody drug Trump received

LA Times  

In an image from video, scientists work with a bioreactor at a Regeneron Pharmaceuticals facility in New York. U.S. health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental medicine that President Trump was given when he was sickened last month. The Food and Drug Administration authorized use …

Roche on track to produce Regeneron’s COVID-19 antibody cocktail
4 years, 1 month ago

Roche on track to produce Regeneron’s COVID-19 antibody cocktail

Al Jazeera  

Roche and Regeneron aim to be able to make two million doses of the antibody cocktail next year, but are awaiting clearance from regulators. Roche Holding AG has completed early tests of its ability to produce large quantities of Regeneron Pharmaceuticals Inc’s COVID-19 antibody treatment, putting it on track to begin manufacturing the drug once it is authorised by regulators, …

Regeneron, Used to Treat Trump's Covid-19, Announces More Positive Results for Covid-19 Treatment
4 years, 1 month ago

Regeneron, Used to Treat Trump's Covid-19, Announces More Positive Results for Covid-19 Treatment

News 18  

Regeneron, the US biotech firm that supplied synthetic antibodies to treat President Donald Trump’s Covid-19, announced Wednesday it had more positive results to show from an ongoing clinical trial. The company had previously announced results for 275 people in its late-stage study of non-hospitalized Covid-19 patients on REGN-COV2, and said data from an additional 524 people bore out the trend. …

Covid: US halts study into promising antibody treatment
4 years, 1 month ago

Covid: US halts study into promising antibody treatment

The Independent  

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Trump’s pursuit of coronavirus vaccine comes at the expense of therapies he now claims as a ‘cure’
4 years, 2 months ago

Trump’s pursuit of coronavirus vaccine comes at the expense of therapies he now claims as a ‘cure’

CNN  

CNN — When President Donald Trump huddled with vaccine makers last spring, the CEO of Regeneron – who landed an audience with the President after a private call to a well-placed White House adviser – made the most of the chance to plug his company’s coronavirus treatment. “He’s always had this magical thinking about biomedical interventions, starting with hydroxychloroquine.” The …

Trump praises Regeneron's COVID-19 antibody treatment with no real proof: All you need to know
4 years, 2 months ago

Trump praises Regeneron's COVID-19 antibody treatment with no real proof: All you need to know

Firstpost  

There are only early indications that REGN-COV2 works, or that it could, against COVID-19. The following day, President Trump took an experimental COVID-19 treatment – an 8 gram dose of US drugmaker Regeneron’s double-antibody cocktail ‘REGN-COV2’. There’s no way of knowing Regeneron’s treatment is a cocktail of two powerful antibodies that are thought to boost immune response to the SARS-CoV-2 …

If I catch covid-19, can I get the medications Donald Trump received?
4 years, 2 months ago

If I catch covid-19, can I get the medications Donald Trump received?

Live Mint  

Here’s what we know about treatments Trump received—and how a person on some of those medicines might be faring at this point in their care It has been more than a week since President Trump was diagnosed with Covid-19, the illness caused by the novel coronavirus, and his physician said Thursday that he has completed his course of therapy. It …

Antibody drugs are no cure but seem promising for COVID-19
4 years, 2 months ago

Antibody drugs are no cure but seem promising for COVID-19

Associated Press  

WASHINGTON — They’re not cures and it’s not likely that everyone will be able to get them as President Donald Trump has suggested. But experimental antibody drugs like the one Trump was given are among the most promising therapies being tested for treating and preventing coronavirus infections. Eli Lilly and Regeneron Pharmaceuticals Inc. are asking the U.S. government to allow …

Trump admits that a vaccine won't be available until after the election
4 years, 2 months ago

Trump admits that a vaccine won't be available until after the election

Daily Mail  

President Donald Trump has admitted that a vaccine will likely not be available until after the November 3 election and called the antibody cocktail drug he received as treatment for the coronavirus a 'cure'. Regeneron, which makes the experimental drug given to President Trump, had not announced the submission of its application for emergency use authorization with the Food and …

Eli Lilly seeks EUA from US Food and Drug Administration for Covid-19 antibody treatment
4 years, 2 months ago

Eli Lilly seeks EUA from US Food and Drug Administration for Covid-19 antibody treatment

CNN  

CNN — Eli Lilly and Company’s monoclonal antibody combination therapy reduced virus levels, hospitalizations and emergency room visits in patients with mild-to-moderate Covid-19, the pharmaceutical company said Wednesday. Based on new interim data and previous study results, the pharmaceutical company said it submitted a request to the US Food and Drug Administration for emergency use authorization for its single monoclonal …

WHAT ARE THE DRUGS TRUMP IS BEING TREATED WITH?
4 years, 2 months ago

WHAT ARE THE DRUGS TRUMP IS BEING TREATED WITH?

Daily Mail  

President Trump has been given at least three potent drugs since announcing he tested positive for COVID-19 on Thursday night: Regeneron's cocktail of lab-made antibodies, the antiviral remdesivir, and the steroid dexamethasone. The drugs he was treated with and their potential side effects are: REGENERON'S EXPERIMENTAL ANTIBODY COCKTAIL DRUG WHEN HE GOT IT: Trump received a single 8 gram dose …

They prepared for years for a pandemic. Now the pressure is on to create a therapy that could help control it
4 years, 6 months ago

They prepared for years for a pandemic. Now the pressure is on to create a therapy that could help control it

CNN  

CNN — Kristin Pascal jokes with friends at Zoom game night that she’s spent the Covid-19 pandemic moving clear liquids around the office. “So we thought, let’s be prepared.” To prepare, Pascal and her team ran speed challenges to see exactly how fast they could create a treatment for an emerging threat. “And, like, growing amounts of pressure.” They work …

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