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It's probably time to reset your expectations about when we'll get a COVID-19 vaccine. The timeline was always aspirational.

Nurse Kath Olmstead gives volunteer Melissa Harting an injection as part of a COVID-19 vaccine trial, developed by the National Institutes of Health and Moderna, on July 27, 2020. Hans Pennink/AP The estimated timelines for when we might see a coronavirus vaccine are slipping.  Anthony Fauci recently said it "could be January, could be later," before the FDA green-lights a coronavirus vaccine. Johnson and Johnson and AstraZeneca have both had to temporarily delay their clinical trials, whi...
Tags: Health, Science, News, Washington Post, New York City, US, Trends, South Africa, Arizona, Food And Drug Administration, Astrazeneca, National Institutes of Health, Fda, Pfizer, Pascal Soriot, Johnson


Gilead sold $873 million worth of its antiviral COVID-19 treatment even though data on its success remains mixed

FILE PHOTO: A vial of remdesivir Reuters Gilead posted its first numbers detailing how much money the pharmaceutical company has made through Veklury, a COVID-19 antiviral treatment.  Gilead sold $873 million worth of Veklury, also known as remdesivir, in three months. The FDA authorized Veklury as the first antiviral treatment approved to treat COVID-19 patients.  Studies on the effectiveness of Veklury present mixed results. The World Health Organization tested  Veklury on more than 2,75...
Tags: News, US, Trends, Healthcare, Food And Drug Administration, Who, World Health Organization, Fda, Antiviral, Gilead Sciences, Gilead, Geoffrey Porges, Andrew Dunn, SVB Leerink, Allana Akhtar, Coronavirus


The US is close to having 'exponential spread' in some areas, and the hardest part may still be ahead, former FDA official says

The country is facing another cycle of the Covid-19 pandemic, and it may be the hardest yet, former Food and Drug Administration Commissioner Dr. Scott Gottlieb said Monday.
Tags: US, Cnn, Food And Drug Administration, Fda, Scott Gottlieb


Taxes also to be decided by several Nov. 3 ballot initiatives

In addition to selecting who gets to go to, or stay in, Washington, D.C., voters across the country on Nov. 3 will decide on a variety of ballot measures. This coming Election Day, citizens in 32 states will decide the fate of 120 statewide initiatives. There also are measures on the ballots in the District of Columbia, Puerto Rico and the U.S. Virgin Islands. And yes, there are plenty of tax questions that will be decided. Ballotpedia, the Wisconsin-based nonprofit that's been tracking electio...
Tags: Texas, Taxes, Colorado, California, Washington, Austin, United States, Arizona, Food And Drug Administration, Wisconsin, Nebraska, Illinois, General Assembly, Golden State, Grand Canyon State, U S Virgin Islands


Symposium: Coronavirus litigation lurks in the shadows

This article is part of a symposium on the Supreme Court’s “shadow docket.” Stephen Wermiel writes the “SCOTUS for law students” column for SCOTUSblog. He is a professor of practice at American University Washington College of Law, where he teaches constitutional law and a seminar on the Supreme Court. The Supreme Court has been wrestling with a steady stream of legal issues related to the coronavirus pandemic, all in the form of emergency applications decided without full briefing or oral argum...
Tags: Texas, Featured, Maryland, Supreme Court, Law, California, Virginia, Chicago, Commerce, San Diego, Food And Drug Administration, Fda, Nevada, Louisiana, Illinois, Orange County


AstraZeneca's COVID-19 vaccine produces an immune response in older people, raising hopes a vaccine will protect those at greatest risk

Dr. Mustafa Gerek is vaccinated in volunteer in trials of a COVID-19 vaccine from China at Ankara City Hospital in Ankara, Turkey on October 13, 2020. Aytac Unal/Anadolu Agency via Getty Images AstraZeneca's COVID-19 vaccine triggers an immune response in elderly people as well as young adults, the drugmaker said Monday.  "Immunogenicity responses were similar between older and younger adults," an AstraZeneca spokesperson said. The vaccine, being developed with the University of Oxford, is...
Tags: White House, China, US, Trends, Bbc, Food And Drug Administration, Astrazeneca, University of Oxford, Anthony Fauci, Financial Times, Ankara Turkey, Fauci, Kate Duffy, Mustafa Gerek, Ankara City Hospital, Aytac Unal Anadolu Agency


US stocks waver as investors mull dwindling chances for near-term stimulus

JOHANNES EISELE/AFP/Getty Images US stocks wavered on Friday as new commentary from the White House cut into hopes for pre-election stimulus.While House Speaker Nancy Pelosi indicated a bill could still be approved before Election Day, Treasury Secretary Steven Mnuchin noted that "significant differences" remain between each side's respective proposals.The tepid session led the S&P 500 to post its first weekly loss in three weeks.Oil sank after Libya announced it will lift production. West...
Tags: Senate, White House, US, Trends, Markets, Bank Of America, Joe Biden, Intel, House, Food And Drug Administration, Treasury, Earnings, Libya, Oil Price, Goldman Sachs, Nancy Pelosi


US stocks climb as traders place bets on last-minute stimulus breakthrough

Traders work on the floor of the New York Stock Exchange shortly after the opening bell in New York, U.S., March 17, 2020. Lucas Jackson/Reuters US stocks gained on Friday as Wall Street monitored Washington for updates to stimulus negotiations.House Speaker Nancy Pelosi previously said she hopes to reach an agreement before the weekend, and said Thursday that Democrats and the White House are "just about there" on a compromise.Still, Senate Republicans are poised to block the measure, and ...
Tags: New York, Washington, Wall Street, Senate, White House, US, Trends, Markets, Joe Biden, Intel, House, Food And Drug Administration, Treasury, Oil Price, Goldman Sachs, Nancy Pelosi


The FDA's panel of experts said its COVID-19 vaccine approval rules aren't strict enough, and could lead to vaccines being rushed out

A volunteer receives an injection from a medical worker. REUTERS/Siphiwe Sibeko The Food and Drug Administration's (FDA) panel of experts questioned the safety standards of the agency's COVID-19 vaccine approval at an advisory meeting Thursday. Independent experts in the FDA's vaccine advisory board said they were concerned about a vaccine being rushed out, and later proving unsafe or ineffective, per Bloomberg. The FDA requires a two-month follow-up after a final vaccine dose before emerg...
Tags: Trends, Bloomberg, Food And Drug Administration, Fda, Pfizer, Donald Trump, Gilead Sciences, Stanford University Medical Center, Siphiwe Sibeko, Diana Zuckerman, National Center for Health Research, COVID, Kate Duffy, Archana Chatterjee, Chicago Medical School, Amanda Cohn


Cuomo warns head of FDA to 'save your soul,' urges against rushed coronavirus vaccine

New York Gov. Andrew Cuomo encouraged Dr. Stephen Hahn, the head of the Food and Drug Administration, to "save your soul" and not kotow...
Tags: Food And Drug Administration, Fda, Andrew Cuomo, Cuomo, Stephen Hahn


FDA Approves Remdesivir to Treat Hospitalized Covid-19 Patients Despite Mixed Trial Results

The Food and Drug Administration has approved remdesivir to treat hospitalized covid-19 patients. The antiviral drug, which is manufactured and sold by the pharmaceutical company Gilead under the brand name Veklury, is the first to be approved for treating the virus in the U.S.Read more...
Tags: Science, Food And Drug Administration, Fda, Gilead, Coronavirus, Covid 19, Sars Cov 2, Remdesivir


Remdesivir Approved By FDA As First COVID-19 Treatment Drug

SACRAMENTO (AP/CBS13) – Remdesivir, an antiviral medicine given to hospitalized patients through an IV, was approved by U.S. regulators on Thursday as the first drug to treat COVID-19. The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health. “The speed and rigor with which we have reached this milestone reflect the shared commitment of Gilead, g...
Tags: Health, News, California, Sacramento, Ap, United States, Food And Drug Administration, World Health Organization, Fda, Donald Trump, Nih, Daniel, Gilead Sciences, Gilead Sciences Inc, Gilead, U S National Institutes of Health


FDA Approves Gilead's Remdesivir as Coronavirus Treatment

The Food and Drug Administration on Thursday approved Gilead Sciences' antiviral drug remdesivir as a treatment for the coronavirus. From a report: In May, the FDA granted the drug an emergency use authorization, allowing hospitals and doctors to use the drug on patients hospitalized with the disease even though the drug has not been formally approved by the agency. The intravenous drug has helped shorten the recovery time of some hospitalized Covid-19 patients. It was one of the drugs used to t...
Tags: Tech, Food And Drug Administration, Fda, Donald Trump, Anthony Fauci, Gilead Sciences, Gilead, Remdesivir


FDA approves remdesivir as treatment for COVID-19 patients in hospital

The Food and Drug Administration on Thursday approved the antiviral drug remdesivir as a treatment for patients with COVID-19 who require hospitalization.         [Author: USA TODAY]
Tags: Usa, News, Food And Drug Administration, Fda, Usa Today


FDA approves remdesivir for hospitalized COVID-19 patients

The Food and Drug Administration on Thursday approved the antiviral drug remdesivir as a treatment for patients with COVID-19 who require hospitalization.         [Author: USA TODAY]
Tags: Usa, News, Food And Drug Administration, Fda, Usa Today


6 vaccine experts told us how they'll decide whether to get a coronavirus shot

Getty Business Insider asked six infectious-disease experts when they'd feel confident getting a coronavirus vaccine.  Their answers varied in terms of which data would convince them.  Richard Condit, a retired University of Florida virologist, said he'd trust the scientists making the critical regulatory decision. Ultimately, if they recommended people his age get the shot, he'd likely get it, he said.  Other experts wanted more. University of Pennsylvania's Dr. Paul Offit emphasized the...
Tags: Science, US, Trends, Public Health, Harvard, Healthcare, Food And Drug Administration, National Institutes of Health, Philadelphia, Fda, University of Pennsylvania, University of Florida, GlaxoSmithKline, Pfizer, Vaccine, Bill


The 9 biggest takeaways from 'Totally Under Control,' a new documentary filmed in secret about the Trump administration's coronavirus response

The official poster for "Totally Under Control," a new documentary about the US government's response to the coronavirus pandemic. Courtesy of Neon "Totally Under Control," a documentary about the US government's response to the coronavirus pandemic, is now streaming on Hulu. It was filmed mostly in secret over five months and blasts the Trump administration for failing to contain the pandemic. Here are nine key takeaways from the film.  Visit Business Insider's homepage for more stori...
Tags: Health, Politics, New York, Science, Movies, Entertainment, Obama, Congress, California, Cdc, Ebay, Senate, White House, China, Virginia, Massachusetts


Study finds lowering nicotine decreases addictiveness of smoking in vulnerable populations

A study in JAMA Network Open provides evidence that, even in smokers from vulnerable populations, reducing nicotine content to low levels decreases addictiveness - a timely finding as the Food and Drug Administration considers a policy to lower nicotine content in all cigarettes sold in the U.S.
Tags: Science, Food And Drug Administration


See the pitch deck a healthcare startup founded by 2 ex-Googlers used to raise $47 million

Welcome to Business Insider's daily healthcare newsletter, your daily dose of pharma, biotech, and healthcare news. Subscribe here to get this newsletter in your inbox every weekday. Hollis Johnson/Business Insider Hello,Today in healthcare news: The pitch deck that convinced J&J to bet on a new kind of healthcare company, Pfizer plans to submit its vaccine in November for emergency authorization if it works, and Keeps co-founders Demetri Karagas and Steven Gutentag Courtesy Keeps ...
Tags: Cdc, US, Trends, West, Healthcare, Food And Drug Administration, Fda, Pfizer, Donald Trump, Johnson Johnson, Gilead Sciences, J J, Moderna, BLAKE DODGE, Thirty Madison, Demetri Karagas


Don't inject politics into vaccine policy

People are already suspicious about vaccines. Political pressure on the Food and Drug Administration will further undermine trust.         [Author: The Ledger]
Tags: News, Food And Drug Administration, Don, The Ledger


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


Pfizer Announcement All But Ends Worries About Pre-Election Day Vaccine Campaign Prop

Pfizer said that it would likely seek emergency approval for a COVID-19 vaccine in late November, citing recent federal guidance that toughened approval standards for a vaccine, despite President Trump’s efforts to push for a shot by the “special day” of Nov. 3. In an open letter released Friday, Pfizer CEO and Chairman Albert Bourla said that “assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of...
Tags: UK, News, Senate, Food And Drug Administration, Astrazeneca, Fda, Pfizer, Vaccine, Trump, Vanderbilt University, HHS, TPM, William Schaffner, Moderna, Schaffner, Muckraker


Remdesivir, the only antiviral authorized for COVID-19 in the US, did not improve chances of survival in a massive WHO study

Remdesivir has an emergency-use authorization for all hospitalized patients with COVID-19 in the US. Reuters A World Health Organization study of more than 2,750 COVID-19 patients suggested that the antiviral drug remdesivir had "little or no effect" on survival. The Solidarity trial, which has not yet been peer-reviewed, found remdesivir did not "substantially affect mortality," reduce the need to ventilate patients, or shorten hospital stays. President Donald Trump received the antiviral...
Tags: US, Trends, European Union, Food And Drug Administration, Who, World Health Organization, Donald Trump, Nih, Solidarity, Gilead, US National Institutes of Health, COVID, Kate Duffy, US Reuters A World Health Organization, WHO Solidarity


Remdesivir, the only antiviral authorized for COVID-19 in US, does not improve chances of survival, a massive WHO study found

Remdesivir has an emergency use authorization for all hospitalized patients with COVID-19 in the US. Reuters A World Health Organization study of more than 2,750 COVID-19 patients suggested that antiviral drug Remdesivir has "little or no effect" on survival. The Solidarity trial, which has not yet been peer-reviewed, found Remdesivir did not "substantially affect mortality," reduce the need to ventilate patients, or shorten hospital stays. President Donald Trump received the antiviral dru...
Tags: US, Trends, Eu, Food And Drug Administration, Who, Donald Trump, Nih, Solidarity, World Health Organization WHO, Gilead, US National Institutes of Health NIH, COVID, Remdesivir, WHO s Solidarity, Kate Duffy, US Reuters A World Health Organization


Regeneron gets FDA approval for Ebola drug

Regeneron Pharmaceuticals Inc. said late Wednesday the Food and Drug Administration approved its treatment for the Ebola virus. The...
Tags: Food And Drug Administration, Fda, Regeneron, Regeneron Pharmaceuticals Inc


The Race for a Super-Antibody Against the Coronavirus

A network of scientists is chasing the pandemic's holy grail: an antibody that protects against not just the virus, but also related pathogens that may threaten humans. From a report: Dozens of companies and academic groups are racing to develop antibody therapies. Already Regeneron and the drug company Eli Lilly have requested emergency use authorizations for their products from the Food and Drug Administration. These drug companies have the long experience and deep pockets needed to win the ra...
Tags: Tech, New Hampshire, Food And Drug Administration, Albert Einstein College of Medicine, Eli Lilly, Regeneron, Kartik Chandran


Don't inject politics into vaccine policy

Our View: People are already suspicious about vaccines. Political pressure on the Food and Drug Administration will further undermine trust.
Tags: News, Food And Drug Administration, Don


Don't inject politics into vaccine policy

Our View: People are already suspicious about vaccines. Political pressure on the Food and Drug Administration will further undermine trust.         [Author: USA TODAY]
Tags: Usa, News, Food And Drug Administration, Usa Today, Don


The return of virtual SCOTUS

Amid an ongoing pandemic, the recent death of Justice Ruth Bader Ginsburg and a looming confirmation battle, the eight justices of the Supreme Court began a new term last Monday. SCOTUStalk host Amy Howe sits down with SCOTUSblog media editor Katie Barlow to discuss the first week of the term, including an apparent procedural tweak to telephonic oral arguments and which justice is now handling emergency appeals from the U.S. Court of Appeals for the 2nd Circuit (Ginsburg had been the “circuit ju...
Tags: Google, Featured, Maryland, Supreme Court, Law, Obama, Gop, Arizona, Food And Drug Administration, Ruth Bader Ginsburg, Oracle, Kennedy, Economist, Trump, Amy, First Circuit


First, a Vaccine Approval. Then 'Chaos and Confusion.'

The United States may be within months of a profound turning point in the country's fight against the coronavirus: the first working vaccine.Demonstrating that a new vaccine was safe and effective in less than a year would shatter the record for speed, the result of seven-day workweeks for scientists and billions of dollars of investment by the government. Provided enough people can get one, the vaccine may slow a pandemic that has already killed 1 million people worldwide.It's tempting ...
Tags: News, United States, New York Times, Food And Drug Administration, Poland, Who, World Health Organization, National Institutes of Health, Fda, University of Florida, Pfizer, Donald Trump, Nih, Centers For Disease Control And Prevention, Latin America, University of Washington