Posts filtered by tags: EUA[x]


 

Coronavirus update: FDA OKs Regeneron antibody EUA; AstraZeneca shows positive vaccine results

U.S. cases surpass 12 million as positive vaccine and antibody treatment news provide hope.
Tags: Astrazeneca, Fda, EUA, Regeneron


FDA announces advisory committee meeting to discuss vaccine candidate for COVID-19

The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.
Tags: Health, Fda, U S Food and Drug Administration, Pfizer Inc, EUA


FDA schedules meeting to discuss emergency use authorization of COVID-19 vaccine from Pfizer

The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.
Tags: Health, Fda, Pfizer, U S Food and Drug Administration, Pfizer Inc, EUA


Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

The FDA issued an EUA for two monoclonal antibodies to be administered together for treating mild to moderate COVID-19 in adults and...
Tags: Fda, EUA


FDA advisory committee to discuss emergency authorization for Pfizer's COVID-19 vaccine

A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. Sarah Silbiger/Getty Images An FDA advisory committee will meet next month to discuss an emergency use authorization (EUA) for Pfizer's COVID-19 vaccine. Earlier this week, Pfizer said clinical trials had shown its vaccine to be 95% effective. "While we cannot predict how long the FDA's review will take, the FDA will review the request as expeditiously as possible, while...
Tags: Science, US, Trends, Food And Drug Administration, Fda, Pfizer, Charles Davis, US Food and Drug Administration, EUA, ECRI, White Oak Maryland, Stephen M Hahn, COVID, Covid-19 Vaccine, Sarah Silbiger Getty, Marcus Schabacker


Pfizer and BioNTech to submit request for emergency use approval of their COVID-19 vaccine today

Two of the companies behind one of the leading COVID-19 vaccine candidates will seek approval from the U.S. Food and Drug Administration for emergency use authorization (EUA) of their preventative treatment with an application to be delivered today. Pfizer and BioNTech, who revealed earlier this week that their vaccine was 95% effective based on Phase 3 clinical trial data, are submitting for the emergency authorization in the U.S., as well as in Australia, Canada, Europe, Japan and the U....
Tags: Health, TC, Europe, Japan, Medicine, Australia, Tech, Medical Research, Canada, United States, United Kingdom, Vaccination, Fda, Pfizer, Biotech, Vaccines


Pfizer says its coronavirus vaccine is 95% effective as it gears up to ask the FDA to authorize the shot

A health care worker injects a patient with a syringe of an experimental coronavirus vaccine. Dogukan Keskinkilic/Anadolu Agency via Getty Images Pfizer's coronavirus vaccine candidate was 95% effective at protecting people against COVID-19, the pharmaceutical giant said in a Wednesday press release. Pfizer shared preliminary results from this late-stage study on November 9. Wednesday's release provided more details that come from the trial's final efficacy analysis. Pfizer began developin...
Tags: Health, Science, US, Trends, Healthcare, Fda, Pfizer, Biotech, Trump, US Food and Drug Administration, EUA, Pharmaceutical, Moderna, Peter Marks, Andrew Dunn, BioNtech


Pfizer says its COVID-19 vaccine is 95% effective in final clinical trial results analysis

Drugmaker Pfizer has provided updated analysis around its COVID-19 vaccine Phase 3 clinical trial data, saying that in the final result of its analysis of the 44,000-participant trial, its COVID-19 vaccine candidate proved 95% percent effective. This is a better efficacy rate than Pfizer reported previously, when it announced a 90% effectiveness metric based on preliminary analysis of the Phase 3 trial data. This result also follows a preliminary data report from Moderna about their own Phase...
Tags: Health, TC, Medicine, Tech, Medical Research, Pfizer, Vaccine, Biotech, Vaccines, U S Food and Drug Administration FDA, EUA, Moderna, BioNtech, Coronavirus, COVID-19, COVID


FDA approves first COVID-19 diagnostic test for at-home use

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results.
Tags: Health, Fda, U S Food and Drug Administration, EUA


Coronavirus live news: US doctors urge Trump to share Covid data; airlines offer testing

Medical establishment says cooperation can save lives; UK pressed to open transatlantic travel corridors; South Australia locks down for 6 daysRepublican senator Chuck Grassley tests positiveTrump administration has ‘checked out’ as Covid-19 surges, experts sayUK urged to open up transatlantic corridors as ‘Covid-free’ flight arrivesUK police can resume issuing instant £10,000 Covid fines 5.19am GMT Regulators in the US have given the go ahead for the emergency use of the first rapid coronav...
Tags: UK, Science, US, World news, Joe Biden, US news, US politics, Infectious Diseases, Chuck Grassley, South Australia, Donald Trump, Trump, Reuters, EUA, Coronavirus


Coronavirus live news: Italy reports highest death toll since 3 April; Iran registers new case record

Italian , when country was in lockdown; Iran says in 24 hoursChemicals in everyday products could hinder vaccine effectivenessSouth Korea forced to tighten Covid measuresPfizer trials vaccine delivery procedures in four US statesModerna vaccine’s effectiveness bodes well for Oxford jabUK coronavirus updates - live 4.14pm GMT The US Food and Drug Administration said on Tuesday it would make public reviews of all data and information regarding the emergency use authorization (EUA) granted ...
Tags: Europe, Science, Africa, US, UK News, World news, Australia news, US news, Iran, Asia Pacific, Middle East and North Africa, Infectious Diseases, Italy, Oxford, Korea, Fda


The man in charge of evaluating coronavirus vaccines for the FDA lays out why it will take weeks to vet a COVID-19 shot

FDA's Dr. Peter Marks Amanda Andrade-Rhoades/Getty Images As coronavirus vaccines inch closer to reality, the man in charge of reviewing the approval applications wants Americans to trust the process. That means we're not going to get surprise Food and Drug Administration approvals in the coming days, despite two COVID-19 vaccine frontrunners announcing success over the past week. The review process will be measured in weeks, Dr. Peters Marks, director of the FDA's center for biologica...
Tags: Health, Science, News, Massachusetts, Trends, Healthcare, Food And Drug Administration, Fda, Pfizer, Biotech, Business Insider, EUA, Pharmaceutical, Marks, Steve Parsons, Moderna


The CEO of Moderna says every American will likely have access to a COVID-19 vaccine by June 2021

Moderna CEO Stephane Bancel. Andrew Harnik/AP Images Moderna CEO Stephane Bancel told Business Insider that a coronavirus vaccine will available to any American adult who wants one by June.  The upstart Massachusetts biotech company said Monday that its experimental vaccine was highly effective at preventing COVID-19 in a late-stage study. Bancel shared his prediction for how the next year plays out as vaccines are distributed, including a return to normal in summer 2021 for the US. For mo...
Tags: Health, Science, Massachusetts, US, Trends, Healthcare, Fda, Pfizer, Biotech, Anthony Fauci, Business Insider, Health And Human Services, US Food and Drug Administration, Fauci, EUA, Moderna


Moderna reports its COVID-19 vaccine is 94.5% effective in first data from Phase 3 trial

Following fast on the heels of Pfizer’s announcement of its COVID-19 vaccine efficacy, Moderna is also sharing positive results from its Phase 3 trial on Monday. The biotech company says that its COVID-19 vaccine candidate has shown efficacy of 94.5% in its first interim data analysis, which covers 95 confirmed COVID cases among its study participants, of which 90 were given the placebo, and only 5 received Moderna’s mRNA-based vaccine. Further, of 11 severe cases of COVID-19, none were found am...
Tags: Health, TC, Messenger, Medicine, Tech, Medical Research, Vaccination, National Institutes of Health, Fda, Pfizer, Vaccine, Biotech, Vaccines, EUA, Moderna, BioNtech


Covid-19 vaccines shouldn’t get emergency-use authorization

I really want a covid-19 vaccine. Like many Americans, I have family members and neighbors who have been sickened and killed by the new coronavirus. My sister is a nurse on a covid-19 ward, and I want her to be able to do her job safely. As a health-care lawyer, I have the utmost confidence in the career scientists at the US Food and Drug Administration who would ultimately determine whether to issue an emergency-use authorization for a covid-19 vaccine. But I am deeply worried about what could ...
Tags: Opinion, Middle East, Innovation, Fda, Pew Research Center, Biotechnology, Zika, US Food and Drug Administration, EUA, Andy Slavitt, US Centers for Disease Control and Prevention CDC, South America Africa Asia, Coronavirus, Related Biological Products Advisory Committee, EUA Pfizer, Reagan Udall Foundation


Here’s everything you need to know about Pfizer’s positive vaccine news (ars technica)

Enlarge / A woman wears a facemask as she walks by the Pfizer world headquarters in New York on November 9, 2020. (credit: Getty | KENA BETANCUR ) An experimental mRNA coronavirus vaccine developed by pharmaceutical giant Pfizer and German firm BioNTech appeared to be more than 90-percent effective at preventing symptomatic COVID-19 cases in an interim analysis of their large Phase III clinical trial. The two companies reported the top-line results of the analysis in a press release early Mon...
Tags: New York, News, Fda, Pfizer, Trump, Beth Mole, US Food and Drug Administration, EUA, KENA BETANCUR, BioNtech


IMAX CEO Calls Potential COVID-19 Vaccine a “Game Changer” for Movie Theaters as AMC Launches Private Rental Program

Movie theaters are in trouble right now, but there might be some light at the end of the tunnel. Yesterday, Pfizer Inc. announced its COVID-19 vaccine could be 90 percent effective, and while nothing is written in stone yet, that’s the best news regarding a potential vaccine we’ve heard yet. And if the vaccine is effective, and its distribution successful, experts predict movie theaters might be able to reopen sooner rather than later in 2021. As a result, the CEO of IMAX is calling the news a ...
Tags: Business and Industry News, AMC, Coronavirus, IMAX, Regal


Eli Lilly COVID Antibody Treatment Gets Emergency FDA Authorization

U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Eli Lilly & Companies investigational monoclonal antibody therapy bamlanivimab for the treatment of... [[ This is a content summary only. Visit my website for full links, other content, and more! ]]
Tags: Innovation, U S Food and Drug Administration, EUA, Eli Lilly Companies


U.S. has a plan to start Pfizer vaccine shots in December: Health Secretary Azar

If Pfizer Inc submits the positive initial data from its COVID-19 vaccine trial to health regulators as quickly as expected, the U.S. government plans to begin vaccinating Americans in December, Health Secretary Alex Azar said on Tuesday. Pfizer on Monday said the vaccine it has been developing with German partner BioNTech SE was 90% effective against COVID-19, based on an early look at results from its large, late-stage trial. The U.S. drugmaker said it expects to have safety data as soon...
Tags: News, Pfizer, Pfizer Inc, EUA, U S government, Azar, Alex Azar


Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

Today, the FDA issued an EUA for an investigational monoclonal antibody therapy for treatment of mild-to-moderate COVID-19 in adult and...
Tags: Fda, EUA


Dr. Fauci predicts no COVID-19 vaccine until at least January, and warns of a 'whole lot of pain' if US cases continue to surge

Dr. Anthony Fauci, Director of National Institute of Allergy and Infectious Diseases. Alex Edelman / AFP via Getty Images A vaccine for COVID-19 isn't likely to be available in the US until at least January, according to Dr. Anthony Fauci, America's top infectious disease expert. Several vaccines are in late-stage trials, and they could be granted emergency authorization in "January, could be later – we don't know," he told the Journal of the American Medical Association. Dr. Fauci also wa...
Tags: UK, New York, US, America, Trends, Atlantic, Philadelphia, Pfizer, Msnbc, Anthony Fauci, Cnbc, US Food and Drug Administration FDA, Fauci, EUA, Journal of the American Medical Association, Moderna


The US will spend $375 million on 300,000 vials of Eli Lilly's experimental COVID-19 antibody therapy — if the FDA approves it

Eli Lilly's antibody therapy is currently pending FDA approval. Reuters Eli Lilly has agreed to supply 300,000 vials of its COVID-19 antibody treatment in the US, pending the treatment's emergency approval by the Food and Drug Administration (FDA). The US government has agreed to spend $375 million on the vials, Eli Lilly said Wednesday.  It said the therapy, bamlanivimab, would be used in "high-risk" patients with mild-to-moderate COVID-19. Patients would not have to pay for the medic...
Tags: Europe, US, Trends, Fda, Donald Trump, Food and Drug Administration FDA, EUA, Eli Lilly, Kate Duffy, Reuters Eli Lilly, EUA Eli Lilly, David A Ricks Lilly


South Korea pharma Celltrion's COVID test gets U.S. emergency use authorisation

South Korea's Celltrion Inc said on Monday it has received emergency use authorisation (EUA) from the U.S. Food & Drug Administration (FDA) for its rapid COVID-19 testing kit Sampinute, which boosted shares of the company and its affiliates. Celltrion said Sampinute delivers coronavirus test results within 10 minutes, with a sensitivity of around 94%. The authorisation came three months after requesting approval in late July and the product has already been launched in the United States in A...
Tags: South Korea, News, United States, EUA, Celltrion Inc, Celltrion, U S Food Drug Administration FDA, Sampinute


Pfizer Says Coronavirus Vaccine Could Be Ready for FDA Review by End of November

Pharmaceutical giant Pfizer has put the kibosh on any dreams of rushing out its experimental covid-19 vaccine before the U.S. election day. The good news is that the company is optimistic that its vaccine will be ready to apply for the Food and Drug Administration’s emergency use authorization (EUA) by the end of…Read more...
Tags: Science, Food And Drug Administration, Fda, Pfizer, Vaccines, EUA, Coronavirus, Covid 19, Emergency Use Authorization


FDA reissues EUA for certain filtering face-piece respirators manufactured in China

Today, the U.S. Food and Drug Administration (FDA) reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH).
Tags: Health, China, Fda, U S Food and Drug Administration FDA, EUA


Eli Lilly seeks EUA from FDA for Covid-19 antibody treatment

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.
Tags: Cnn, Fda, Eli Lilly and Company, EUA, Eli Lilly


Trump's coronavirus vaccine czar is siding with the FDA on safety standards that would make a vaccine approval unlikely if not impossible before the election

Dr Moncef Slaoui speaks at a White House press conference on May 15, 2020, announcing a program to rapidly develop a coronavirus vaccine. AP Photo/Alex Brandon The man in charge of the Trump administration's efforts to aid the development of coronavirus vaccines told Business Insider he supports a decision to require two months of safety data before approving any COVID-19 vaccine. "I do think it is appropriate to set the threshold of safety follow-up," Moncef Slaoui, the scientific head of...
Tags: Health, New York, Science, White House, US, Trends, Healthcare, Fda, GlaxoSmithKline, Pfizer, Biotech, Donald Trump, Anthony Fauci, Trump, US Food and Drug Administration, EUA


Trump's coronavirus vaccine czar is siding with the FDA on safety standards that make a vaccine approval unlikely if not impossible before the election

Dr Moncef Slaoui speaks at a White House press conference on May 15, 2020, announcing a program to rapidly develop a coronavirus vaccine. AP Photo/Alex Brandon The man in charge of the Trump administration's efforts to aid the development of coronavirus vaccines told Business Insider he supports a decision to require two months of safety data before approving any COVID-19 vaccine. "I do think it is appropriate to set the threshold of safety follow-up," Moncef Slaoui, the scientific head of...
Tags: Health, New York, Science, White House, US, Trends, Healthcare, Fda, GlaxoSmithKline, Pfizer, Biotech, Donald Trump, Anthony Fauci, Business Insider, Trump, US Food and Drug Administration


Trump's coronavirus vaccine czar is backing the FDA on safety standards that make a vaccine approval unlikely if not impossible before the election

Dr Moncef Slaoui speaks at a White House press conference on May 15, 2020, announcing a program to rapidly develop a coronavirus vaccine. AP Photo/Alex Brandon The man in charge of the Trump administration's efforts to aid the development of coronavirus vaccines told Business Insider he supports a decision to require two months of safety data before approving any COVID-19 vaccine. "I do think it is appropriate to set the threshold of safety follow-up," Moncef Slaoui, the scientific head of...
Tags: Health, New York, Science, White House, US, Trends, Healthcare, Fda, GlaxoSmithKline, Pfizer, Biotech, Donald Trump, Anthony Fauci, Business Insider, Trump, US Food and Drug Administration


U.S. FDA safety guidelines likely to push COVID-19 vaccine authorization past election

A senior administration official confirmed the White House had approved the plan, which undercuts President Donald Trump's hopes of getting a vaccine before voters go to polls. The FDA released the guidance laying out more stringent recommendations for drugmakers hoping to apply for an emergency use authorization (EUA) for their experimental vaccines.
Tags: News, White House, Fda, Donald Trump, EUA