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   Biotech / MedicalCoronavirus / COVID-19 Pandemic


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From: Glenn Petersen10/27/2020 6:57:04 AM
1 Recommendation   of 20291
 
Lilly antibody drug fails in a Covid-19 study; others go on

PUBLISHED MON, OCT 26 20208:02 PM EDT
UPDATED MON, OCT 26 20208:06 PM EDT
Associated Press via CNBC.com

KEY POINTS

-- Independent monitors had paused enrollment in the study two weeks ago because of a possible safety issue.

-- But on Monday, the National Institute of Allergy and Infectious Diseases, which sponsors the study, said a closer look did not verify a safety problem but found a low chance that the drug would prove helpful for hospitalized patients.

-- In a statement Lilly notes that the government is continuing a separate study testing the antibody drug in mild to moderately ill patients, to try to prevent hospitalization and severe illness.

U.S. government officials are putting an early end to a study testing an Eli Lilly antibody drug for people hospitalized with Covid-19 because it doesn’t seem to be helping them.

Independent monitors had paused enrollment in the study two weeks ago because of a possible safety issue. But on Monday, the National Institute of Allergy and Infectious Diseases, which sponsors the study, said a closer look did not verify a safety problem but found a low chance that the drug would prove helpful for hospitalized patients.

It is a setback for one of the most promising treatment approaches for Covid-19. President Donald Trump received a similar experimental, two-antibody drug from Regeneron Pharmaceuticals Inc. on an emergency basis when he was sickened with the coronavirus earlier this month.

In a statement Lilly notes that the government is continuing a separate study testing the antibody drug in mild to moderately ill patients, to try to prevent hospitalization and severe illness. The company also is continuing its own studies testing the drug, which is being developed with the Canadian company AbCellera.

Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help it be eliminated. The experimental drugs are concentrated versions of one or two specific antibodies that worked best against the coronavirus in lab and animal tests.

Lilly and Regeneron have asked the U.S. Food and Drug Administration to grant emergency use authorization for their drugs for Covid-19 while late-stage studies continue. Lilly says its request is based on other results suggesting the drug helps patients who are not hospitalized, and that it will continue to seek the FDA’s permission for emergency use.

cnbc.com

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From: Julius Wong10/27/2020 7:28:12 AM
6 Recommendations   of 20291
 
British study shows evidence of waning immunity to Covid-19

cnn.com

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From: Glenn Petersen10/27/2020 8:08:42 AM
1 Recommendation   of 20291
 
Pfizer’s late-stage coronavirus vaccine trial is near complete enrollment with 42,000 volunteers

PUBLISHED TUE, OCT 27 20206:54 AM EDT
UPDATED 16 MIN AGO
B erkeley Lovelace Jr. @BERKELEYJR
CNBC.com
KEY POINTS

-- Pfizer’s late-stage coronavirus vaccine trial has enrolled more than 42,000 volunteers, the company announced when it released a mixed third-quarter earnings report.

-- Pfizer said nearly 36,000 of the volunteers have already received the second of its two-dose Covid-19 vaccine.

Pfizer’s late-stage coronavirus vaccine trial has enrolled more than 42,000 volunteers, the company announced Tuesday when it released a mixed third-quarter earnings report.

It said nearly 36,000 of the volunteers have already received the second of its two-dose Covid-19 vaccine. Pfizer has as been working alongside German drugmaker BioNTech on the experimental vaccine. It contains genetic material called messenger RNA, or mRNA, which scientists hope provokes the immune system to fight the virus.

In September, Pfizer expanded the enrollment of its phase three trial to up to 44,000 volunteers from the initial target of up to 30,000. The company said the expansion would allow it to further increase diversity in the trial as well as include adolescents as young as 16 years old and people with preexisting conditions.

The phase three trials are a critical last step needed to get the vaccines cleared for distribution. Three other U.S.-backed candidates are in phase three: Moderna, AstraZeneca and Johnson & Johnson. Pfizer expects to apply for an emergency use authorization with the Food and Drug Administration next month.

In an earnings slide, Pfizer said the data monitoring board, which will assess whether the trial has been successful, has not conducted an interim efficacy analyses yet.

The update on the trial comes as Pfizer reports a mixed quarter. Third-quarter sales dropped by 4.3%, hurt in part by lower demand for some of its drugs due to the pandemic.

Sales fell to $12.13 billion, down from $12.68 billion a year earlier and lower than the $12.32 billion Wall Street analysts surveyed by Refinitiv were expecting. Still, the company’s profits were slightly better than expected at 72 cents per share, higher than the 71 cents analysts were expecting.

Pfizer will hold an earnings call at 10 a.m. ET where investors will await further details on its vaccine.

Shares of the company were essentially flat in premarket trading Tuesday.

cnbc.com

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To: kidl who wrote (9912)10/27/2020 8:21:18 AM
From: Sam
   of 20291
 
Is there another head of state who portraits Covid as a "topic" purely designed to undermine his leadership?

It must be a world wide conspiracy to undermine The Donald. They are all in on it because they are afraid of him and his leadership which will make it impossible for them to take advantage of the US like they have been doing for so long.

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From: Julius Wong10/27/2020 8:57:08 AM
   of 20291
 
Eli Lilly COVID-19 antibody treatment comes up empty in NIAID study
Oct. 27, 2020 7:05 AM ET|About: Eli Lilly and Company (LLY)|By: Douglas W. House, SA News Editor

NIH's National Institute of Allergy and Infectious Diseases (NIAID) will not enroll any more participants in a substudy in a Phase 3 clinical trial, ACTIV-3, evaluating Eli Lilly's (NYSE: LLY) investigational monoclonal antibody LY-CoV555 in hospitalized COVID-19 patients due to the low likelihood that it will demonstrate a treatment benefit.

The independent Data and Safety Monitoring Board (DSMB) reviewed the results yesterday and recommended that no further participants be randomized and the data be unblinded. Enrollment closed with 326 subjects.

The study was assessing the LY-CoV555 plus standard-of-care (SOC) treatment, including Gilead Sciences' (NASDAQ: GILD) Veklury (remdesivir), compared to placebo + SOC.

The primary endpoints were pulmonary ordinal outcome at day 5, pulmonary + ordinal outcome at day 5 and time from randomization to sustained recovery up to day 90.

Participants will be continue to be followed until day 90. NIAID and trial-coordinating investigators are continuing their analyses of the results and will release additional information in another report.

LLY is down 5% premarket on light volume. GILD is down a fraction.

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From: Wharf Rat10/27/2020 9:41:09 AM
4 Recommendations   of 20291
 
A Right-Wing Think Tank Is Behind the Controversial Great Barrington Declaration Calling for COVID-19 Herd Immunity

The institution behind the Great Barrington Declaration, the American Institute for Economic Research (AIER), is a free-market think tank tied to funding from the Koch petrochemical and industrial empire and an investment firm with significant holdings in fossil fuels.

desmogblog.com

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To: Wharf Rat who wrote (9936)10/27/2020 9:54:59 AM
From: Sam
   of 20291
 
Gee, what a surprise....

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To: Moonray who wrote (9928)10/27/2020 10:37:44 AM
From: marcher
2 Recommendations   of 20291
 
...Abbott’s rapid coronavirus tests, called the ID NOW and BinaxNOW, are speedy, portable and easy to operate, delivering results in minutes. But the convenience comes at a cost: The products are less accurate than laboratory tests that use a technique called polymerase chain reaction, or P.C.R., and they more frequently miss infections or mistakenly designate healthy people as infected...

nytimes.com

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From: Thomas M.10/27/2020 10:45:44 AM
   of 20291
 
We are doing 6 times as many tests per day as we were earlier in the year.



Tom

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To: marcher who wrote (9938)10/27/2020 11:05:37 AM
From: marcher
1 Recommendation   of 20291
 
hhs statement about binaxnow:
hhs.gov

fda august statement:
fda.gov

atlantic october article:
theatlantic.com


“...The point I'm trying to make here, and I'll be blunt, is that antigen testing will not and cannot work for asymptomatic screening, and [it] will probably kill a lot of people,” Geoffrey Baird, the acting laboratory-medicine chair at the University of Washington, told us...
The [FDA] emergency use authorization only covered testing for people within the first seven days of developing symptoms, when viral loads remain high.

...in the general, symptom-free population, the expected levels of infection are actually quite low, so the false-positive rate could be very high.

...“One branch of the government is saying, ‘Use this test for asymptomatic people,’ and then on the other side, they are saying, ‘Use this test for symptomatic people,’” he said. Baird is particularly anxious that the performance of tests will deteriorate in the field and when applied to asymptomatic people.



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