Experimental Antibody Treatment for Covid-19 Patients Wins 'Emergency Approval' in America (msn.com) 81
America's Food and Drug Administration granted emergency authorization Saturday to an experimental antibody treatment (for people already experiencing Covid-19), reports the Washington Post:
The drug, made by Regeneron Pharmaceuticals, is designed to prevent infected people from developing severe illness. Instead of waiting for the body to develop its own protective immune response, the drug imitates the body's natural defenses. It is the second drug of this type — called a monoclonal antibody — to be cleared for treating covid-19. The FDA authorized Eli Lilly & Co.'s drug on Nov. 9.
Regeneron's drug is a cocktail of two monoclonal antibodies, called casirivimab and imdevimab. The FDA said in authorizing the cocktail that it may be effective in treating mild to moderate covid-19 in adults and children 12 or older, and is indicated for those at high risk of developing severe illness. Doctors hope the drugs will keep those patients from being hospitalized... Regeneron executives said on the company's earnings call in early November that they project having enough doses for 80,000 patients by the end of November, and 300,000 total doses by the end of January...
In a clinical trial, the Regeneron drug reduced hospitalizations or emergency room visits when given to people at high risk of developing severe disease. It was also shown to reduce the amount of virus in people's bodies... The safety and effectiveness of the drug will continue to be studied. It is not authorized for use in hospitalized patients... In a study published Oct. 28 in the New England Journal of Medicine, researchers said the Lilly cocktail lowered the risk of follow-up medical visits and reduced levels of virus in people with mild to moderate symptoms of covid-19.
The progress on monoclonal antibodies comes as pharmaceutical and biotech companies are racing to produce coronavirus vaccines... The antibody treatments can play an important role in making the disease less dangerous.
Regeneron's drug is a cocktail of two monoclonal antibodies, called casirivimab and imdevimab. The FDA said in authorizing the cocktail that it may be effective in treating mild to moderate covid-19 in adults and children 12 or older, and is indicated for those at high risk of developing severe illness. Doctors hope the drugs will keep those patients from being hospitalized... Regeneron executives said on the company's earnings call in early November that they project having enough doses for 80,000 patients by the end of November, and 300,000 total doses by the end of January...
In a clinical trial, the Regeneron drug reduced hospitalizations or emergency room visits when given to people at high risk of developing severe disease. It was also shown to reduce the amount of virus in people's bodies... The safety and effectiveness of the drug will continue to be studied. It is not authorized for use in hospitalized patients... In a study published Oct. 28 in the New England Journal of Medicine, researchers said the Lilly cocktail lowered the risk of follow-up medical visits and reduced levels of virus in people with mild to moderate symptoms of covid-19.
The progress on monoclonal antibodies comes as pharmaceutical and biotech companies are racing to produce coronavirus vaccines... The antibody treatments can play an important role in making the disease less dangerous.
Re: $34,000.00 a dose (Score:1)
Don't be silly. This will be a big government deal.
$34,000,000.00 per dose!
Re: $34,000.00 a dose (Score:5, Informative)
Don't be silly. This will be a big government deal.
$34,000,000.00 per dose!
From TFA:
the government has bought 300,000 doses each from Lilly and Regeneron at a cost of about $1,250 and $1,500 per dose, respectively
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Re: $34,000.00 a dose (Score:4, Insightful)
Re: $34,000.00 a dose (Score:5, Insightful)
It's also a bargain compared to paying people to stay at home for only a few weeks.
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I was going with the prices from TFA, my friend. I would also love very much getting paid 34K$ for a few weeks of work. Unless "a few weeks" means 52.
So it's not hydroxychloroquine then? (Score:2, Insightful)
Might Orange Man have been wrong?
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I guess if you're totally ignorant of the fact that Trump was funding and supporting this treatment from Regeneron a long time ago [whitehouse.gov]...
But yeah, if your only news sources are left-wing rags, then you may have never heard anything positive about President Trump over the last few years.
Re: No thanks to democrats (Score:1)
Well, there *is* no vaccine before 2021.
As you might have noticed, this is not up to scrutiny with what we expect before calling something a vaccine. Hence the nee for a emergency approval.
Also, your orange-based deity with its de-funding of science and education and empowering stupid people and claimin bleach is a vaccine isn't exactly to credit for this, now is he.
You are too cretin for this though.
Re:No thanks to democrats (Score:4, Insightful)
For heaven slakes stop being a partisan idiot!
Did you take the vaccine yet? Probably not unless you decided to put yourself into drug testing.
When do you honestly expect large scale deployment so Americans can get the Vaccines? Being that we are in late November of 2020 with 39 days left in the year? To get production up and being able to ramp up millions of affordable units, it will take a while. So yes there will be no vaccine before 2021.
Politicians are not scientist, so they will not get a fine detail on what will happen. However unlike the president. The Democrats were giving a much more realistic time frame. Remember when Trump said, it will only be two Weeks, then by Easter, Summer, Before the Election... This will all be over. Encouraging the other Parisian Idiots to reject safety measures such as Social Distancing and Masks and now the infection rate is at an all time high. So for us people who follow "LiBeRaL MeDiA" and listen to the warnings, had taken many of the measures seriously and prepped ourselves for it to be a long term problem. We are being much more safe, while especially Red States, and Red Areas of Blue States are seeing a lot more infections.
Yes the Trump Administration had done some things to help speed up vaccine development up a bit. However he had failed to lead America during a disaster, and encouraged reckless behavior.
So thanks to the Democrats and their Leadership, a lot of us are still alive, and uninfected. While the Trump Administration did more Harm than good.
To be perfectly accurate, about 40 million today (Score:5, Informative)
> ramp up millions of affordable units, it will take a while. So yes there will be no vaccine before 2021.
To be perfectly accurate, we have about 40 million doses as of today. In a week or two it'll be approved for use. By the end of the year, we'll have maybe 100 million. So yeah we so in fact have "millions of units".
While Trump is certainly a jackass, part of his Operation Warp Speed was producing the most likely vaccines BEFORE the studies were completed, so they'd be available for immediate use if and when the studies proved efficacy. *That* was a good idea.
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Yes, but in terms of providing information that is going to be useful for general population behavior. Saying after 2021 is a perfectly reasonable and responsible statement. 40 million units sounds like a lot, however that will not be enough to slow down the infection rate, it will need to be distributed to the most venerable groups. (These groups are also the most resistant on being first to try a new drug, because of some bad history)
Ps - he lost, so now we can shift gears (Score:2)
Until three weeks ago, Trump was running for re-election.
So it made sense to try to convince people that he's a horrible choice, or a wonderful choice. It could affect the outcome of the upcoming election.
Trump lost. In seven weeks he'll be heading out of Washington.
So that part is over.
Now is the time to shift our focus and our mindset. Now we have the task of putting aside "rooting for our team" and watching the game tapes to learn what worked well and what didn't. If we keep just rooting for our team at
Truth and elections (Score:2, Informative)
Gore only finally conceded on December 13, 2000 — and Democrats continue to claim "Bush was selected not elected" to this day...
But don't let the above stop you from reversing some of the more vile lies told about the man and his performance. Thank you.
I'd like four more years of that guy — I don't deal with him personally, so his being a jackass (if he is that), does not affect me
Gore's loss came down to 1 state (Score:2)
Moreover Bush got us Mired into Iraq & Afghanistan based on lies. That's a historic fact. Whether you consider that incompetence, bad judgement or malice is up to you. It's not a good look either way.
So you can understand why, when we're shipping the children of Iraq war vets off to fight in the war their dads
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There is plenty of evidence today, multiple states had massive election fraud. If we simply applied the standards we applied to elections in other countries before, we'd denounce our own elections as fraudulent. The tell-tale signs [bbc.com] are all over. For example, we considered Ukrainian elections in 2004 fraudulent [state.gov], because, of:
Subtraction (Score:2)
> Gore only finally conceded on December 13, 2000
Yep. You pointed out the year. How long ago was that?
Twenty years ago? Before some of today's voters were even *born*. You're living in twenty years ago?
Re:Truth and elections (Score:4, Informative)
That's because in 2000, the whole thing came down to less than 1000 votes in a single state that never did manage to do a recount and a then rare case where the results in the EC were in opposition to the nationwide popular vote.
Nevertheless, Gore did concede for the good of the country.
Currently, we are looking at margins of not less than 10,000 and the states have already recounted and certified their results. It looks like Georgia will actually do TWO recounts and the GOP is still throwing one of their own under the bus.
Then there's the matter of a sitting President, who took an oath to defend the country and it's Constitution urging legislatures to just throw out the entirety of the ballots and make an un-democratic decision that he gets to be President again...
And then just to show us what he's really made of, he skips out on a G20 meeting to discuss combating the pandemic to play a few rounds of golf.
Is that REALLY the sort of person you want running the country?
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I don't see the relevance of this objection. Does a victim of fraud lose the right to fight it, when the fraud is too big?
What fraud? I'm going to have to say ***CITATION NEEDED*** to that one. Multiple judges in multiple courts in multiple suits across several states have ruled that no evidence was presented AT ALL for anything.
The relevance is the usual margin of error in a ballot count. In 2000, the margin of victory fell within the margin of error (as they say in science, the signal was lost in the noise). Here in 2020, the margin of victory for Biden is well beyond the margin of error and just to be safe there have been
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By the standards we — rightfully — used, when judging the elections-fairness in other countries [slashdot.org], there's been plenty of fraud.
A comment like this, made by a Conservative, would cause a Facebook account be suspended for racism.
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No, I want evidence you wouldn't be ashamed to bring before a judge. Where is it?
Put up or shut up.
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Much like the 'fraud' your team is claiming.
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That's funny... Trump had endure years of investigations based on wet-dreams of a British spy fed material by Putin. We just lived through the riots motivated — as well as excused and encouraged — by baseless accusations of police racism. Search as might, I can find you demanding courtroom-grade evidence in any of those case.
But now that we're discussing elections-fraud, you insist on the standard of evidence stronger, than our
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I made that statement in light of actual court decisions. That is, Trump got his day in court and was sent packing when it turned out he hadn't a single shred of evidence.
If you actually looked over my posting history, you would have seen that I questioned if the problem was police racism or just violence in general.
Even now, my suggestion was that if you had actual evidence that might have any value in court, you should bring it forward and make it known. Based on your response, I'm guessing you have none?
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And my point remains, that we've denounced other countries' elections as unfair with the same evidence we have today about fraud in our own...
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Not really, no. Your link needed a lot of really desperate stretching to make even a half-assed comparison. Also it needed taking the word of Trump supporters in spite of their arguments being shot down by every judge that reviewed them every single time.
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At least some of the judges in this case were Republicans.
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What Supreme court ruling? If you think this is going to get to the Supreme Court, you're in La La Land.
While Adam and Jamie proved that with sufficient determination, you can, in fact, polish a turd, there's no polishing whatever that is Giuliani has been spewing.
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Ok, but if it does get there — and the ruling is in Trump's favor, will you accept it?
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The economic prosperity of 2016-2019, until the pandemic interrupted things, was amazing. Best job prospects ever for black Americans, etc. Now if you're stuck in rooting for your team, you want to deny that happened. Just because Trump happens to be a jackass, you'd be tempted to NOT learn from what worked well. You'd then go back to policies that result in more crack in low-income neighborhoods instead of more jobs. Which is more important, hating some dude who uses to be president, or actually helping millions of people?
I say it's time to be done focusing on hating the guy who is on the way out the door and start focusing on helping the country be better for all of us.
Why are you under the assumption that we aren't going to separate the orange man from his positive actions? It's plenty easy to learn from what this sociopath happen to do right while not giving him any credit for it and tossing his selfish, lying.ass under the bus.
Re:To be perfectly accurate, about 40 million toda (Score:4, Informative)
Everyone had that idea, and many publicized it. Even Billy G had it before Trump did. It's not Trump's idea.
Trump also didn't chip in any money for any vaccines, only made a promise to buy them, and we all know what Trump's promises are worth. Dolly Parton literally did more to produce a vaccine than did Trump.
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The staffer who convinced Trump to use the name 'Operation Warp Speed' is the real hero. With that, Trump had something he and his supporters could understand.
It's probably the only thing that kept Trump from effing it all up.
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"So yeah we so in fact have "millions of units"."
Who is this "we" that will, in fact, have "millions of units"? Is it doctors? Health care generally? People who can actually administer the vaccines? No, of course not.
"We" being a manufacturer that is in the process of earliest production doesn't matter at all, what matters when people can receive the vaccine. So far we have none and won't have any until at least there is a approval, manufacturing and distribution. There are 5 weeks left in the year.
".
Vaccinations start December 11 (Score:2)
> So far we have none and won't have any until at least there is a approval, manufacturing and distribution. There are 5 weeks left in the year.
You don't seem to be understanding that manufacturing has been occurring for the last two months. Approval should be December 8th or 9th. Distribution is in place so vaccinations are scheduled to begin December 11. This is the expected schedule for Dr. Slaoui.
>an obvious thing to do
And yet you still don't seem to *quite* understand the concept.
You're still s
Re: To be perfectly accurate, about 40 million tod (Score:2)
we have about 40 million doses as of today.
That's more than both Moderna and Pfizer are predicting... Combined... By Jan 1st.
Pfizer a month ago said they had a couple hundred thousand doses ready.
We hopefully will have 40m before the end of the year. But many are going to other countries and the third world as well. So we won't get everything.
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Well as of TWO WEEKS AGO, Pfizer had already *adminstered* 90,000 doses and Moderna about the same number, so ...
A couple hundred thousand would be how many doses have already been administered today.
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I can certainly understand your concern.
Like you said, one time the Philippines government approved a vaccine after a study that didn't account for what makes dengue so different from other diseases. It was noted that other countries didn't think it was ready for approval, but the Philippines government went ahead and used it since dengue was killing a lot of people. As you may know, after the Philippine government screwed that up, hundreds of people died after being vaccinated.
Philippines doesn't use the
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> which has lead to 300,000 of your countrymen dying and their bodies being stuck in freezer trucks.
Vaccinating people after experts around the world agree that it's safe and effective has killed 300,000 people in some country? What country is that? What the *hell* are you talking about?
Re: (Score:2)
> Let me know when you tell your side to start to apply the same standard to their Thanksgiving Travel plans and mask wearing in public...
I'm not sure I'm understanding you, so let me clarify.
You're saying that before traveling for the holidays, people should listen to the consensus of experts around the world? Just like they should when it comes to medications? Is that correct, or did I misunderstand you?
Moving goalposts (Score:1, Interesting)
Amazing, Trump leads America and organizes "Warp Speed" and produces a vaccine. Now democrats say, it doesn't count unless every single man, woman, child, cat, dog, and world has the vaccine first. Until then, doesn't count. Meanwhile "El Supremo" Overlord Biden has pledged that he will ship any vaccines to the world at large BEFORE giving it to US citizens. Democrats just refuse to give Trump credit. And then you accuse me of being partian.
Now as far as being an idiot, that I will grant. Biden has already
Re: Moving goalposts (Score:3)
Hard to say Trump "led" anything since they basically haven't had a covid task force meeting since July 3rd.
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Worst president in a lifetime was Hussein Obama. I'll give him credit, the man could speak well, but he was all talk and no action. Trump to be fair doesn't speak as well as Hussein Obama, but he definitely got things done. Where Hussein Obama literally bowed in subservience to the Muslim we can expect "Il Duce Supremo" Biden to do the same for the Chinese.
So exactly like Russia then? (Score:1)
Exprimental *is* good enough, after all?
But yours is different. And there is an emergency. And dicks are to be compared?
That's what the Russians told us too.
You two are such pansies. ;)
If we weren't in the middle, I'say fight it out. Huge nuclear dick slapping contest. We'll declare what corpse got the biggest. And reclaim the wasteland afterwards.
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Not inclined to recommend it... (Score:2)
Personally, I'm not one to trust a medical treatment pushed by a company whose executives dump a million dollars worth of stock options the day after the president claims their miracle drug is a cure [nbcnews.com]. CEOs who are confident in their product stand by it [king5.com]. Snake oil salesmen get outta town the moment they know shit's about to hit the fan.
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OK, Ivan. We got your message, and you presumably got paid. You can run along now.
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Personally, I'm not one to trust a medical treatment pushed by a company whose executives dump a million dollars worth of stock options the day after the president claims their miracle drug is a cure [nbcnews.com].
"Sell on the news" is standard investment advice, whether the company's product is medications or car mufflers.
Go ahead and sacrifice yourself for Jesus. If I get Covid, I'm taking this treatment.
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Personally, I'm not one to trust a medical treatment pushed by a company whose executives dump a million dollars worth of stock options the day after the president claims their miracle drug is a cure [nbcnews.com]. CEOs who are confident in their product stand by it [king5.com].
So what you're saying is that rich people don't like money and would not take advantage of a temporal spike in value due to endorsement from POTUS?
I get what you're saying, if you're confident in your business you wouldn't dump stock. However it doesn't matter how much confidence you have in your business. Big pharma is predominantly a blue-chip stock with stability and competition. Their product could be completely perfect and it won't move the price even remotely as much as a media blitz endorsement of a
And there's already a commercial for it! (Score:2)
A commercial starring His Orangeness, no less: https://www.youtube.com/watch?... [youtube.com]
Expect more such deals (Score:2)
I think we can expect more of regulatory approvals in th
America? (Score:1)
I apologize for being pedantic and off topic (and acknowledge that it is both), but I get frustrated when the term "America" is used as a proxy for the place called the United States of America. Why not say "U.S." or "U.S.A."? Canada is in "America", as is Mexico, and Brazil, and Peru, and Honduras, and every other country in North and South America. I get that "American" has generally been accepted as meaning "someone from the United States", but geographically the U.S. is a part of the Americas. It's jar
Re: America? (Score:4, Insightful)
Maybe because the US is the only state in the Western hemisphere with "America" in the name? This is also a US website that uses primarily US sources, and "America" is commonly used worldwide to apply to the US. Hell, even Iran shouts "death to America" and not "death to the US" and no one assumes they are talking about Mexico, or Brazil, or Chile.
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It's short for "the United States of". But you knew that already. Who ever says "The Dominion of Canada"? Nobody.
but I get frustrated when the term "America" is used as a proxy
"Why" would be a good question to explore here. It appears you have some deep-seated issues.
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The Free State of Saxony was never part of Saxon territory, and wasn't even attached to an entity with "Saxony" in the name until the 15th century.
Where is your outrage for that?
Hmmm. Apparently, used on trump (Score:2)
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It was already approved for use with a compassionate use exception waiver, which Trump's doctors applied for to he company and then the FDA for him and got approved (like a dozen or so others did). The others who already got it were included in the various clinical trials, which is the preferred pre-approval method to get a new treatment.
Is this the drug (Score:2)
which uses ground up babies, or was that the one the con artist received and which Evangelicals cheered his miraculous recovery?
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The Trump Administration paid closer to $1,200 per dose back in July when they agreed to pre-fund $450 million worth of production.