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153 workers at Houston Methodist Hospital quit or were fired after they refused a mandatory COVID-19 vaccine

The hospital said in late March that it would mandate COVID-19 vaccines for its 26,000 employees. FREDERIC J. BROWN/AFP via Getty Images Houston Methodist Hospital told The Washington Post that it had fired staff who refused a COVID-19 shot. Some staff quit over the vaccine mandate, too. More than 150 staff had left or were fired, it said. Earlier this month a judge dismissed a lawsuit that said the mandate treated staff like "guinea pigs." See more stories on Insider's business page. ...
Tags: Post, Texas, News, US, Trends, Healthcare, Delta, Goldman Sachs, Fda, Houston, The Washington Post, United Airlines, US Food and Drug Administration, Houston Methodist Hospital, Houston Methodist, Frederic J Brown


Behind the historic US vaccine effort is FDA's Peter Marks. The job is 'not for the faint of heart.'

The FDA's Dr. Peter Marks has played a key role in nearly every major vaccine-related decision since the United States' COVID-19 outbreak began.       [Author: USA TODAY]
Tags: Usa, News, US, United States, Fda, Usa Today, Peter Marks


United States: FDA Withdraws Notice Of Proposed Rulemaking For Premium Cigars - Troutman Pepper Hamilton Sanders

On June 11, 2021, the U.S. Food and Drug Administration (FDA) withdrew an advanced notice of proposed rulemaking (ANPRM) for premium cigars issued in March 2018 as part of the Spring 2021...
Tags: News, United States, Fda, U S Food and Drug Administration FDA, Premium Cigars Troutman Pepper Hamilton Sanders


Former FDA Chief Says COVID-19 Variant May Cause Surge In States With Low Vaccination

The warnings echo those of Dr. Anthony Fauci, who urged Americans earlier this month to get their vaccinations.
Tags: News, Fda, Anthony Fauci, COVID


New Alzheimer's drug sets dangerous precedent

Doctors Reshma Ramachandran and Joe Ross write that normally, FDA approval of a drug means that the agency has done its due diligence in reviewing data from pivotal clinical trials, confirming that the drug has proven benefits that outweigh any known or potential risks. But this was not the case for the newly-approved Alzheimer's drug, Aduhelm.
Tags: Cnn, Fda, Joe Ross, Reshma Ramachandran


The Biden administration plans to invest $3.2 billion in COVID-19 antiviral drugs

President Joe Biden. Evan Vucci/AP The Biden administration is putting $3.2 billion toward antiviral medicines for COVID-19. The ideal drug could be taken early in the course of an illness to prevent hospitalization. So far, the FDA has only approved one drug to treat COVID-19 in hospitalized patients. See more stories on Insider's business page. The Biden administration announced on Thursday that it will invest $3.2 billion in the development and manufacturing of antiviral medicines f...
Tags: Politics, News, Trends, Healthcare, Food And Drug Administration, World Health Organization, National Institutes of Health, Fda, The New York Times, Biden, Anthony Fauci, Fauci, National Institute of Allergy, Pandemic, Breaking, COVID


Why The FDA’s Approval Of A New Alzheimer’s Drug Should Worry You

Aduhelm may be a case study in everything that's wrong with how America manages prescription drugs.
Tags: News, America, Fda


United States: FDA Releases Guidance On The Drug Supply Chain Security Act - Arnold & Porter

On June 3, 2021, the US Food and Drug Administration (FDA) released one new draft guidance, two final guidances, and a revised draft guidance document regarding the Drug Supply Chain Security Act (DSCSA).
Tags: News, United States, Fda, Porter, US Food and Drug Administration FDA


A federal judge just ruled against over 100 Houston hospital workers who will be fired if they don't get the COVID-19 vaccine

Medical workers and pedestrians cross an intersection outside of the Houston Methodist Hospital on June 09, 2021 in Houston, Texas. Getty Images/Brandon Bell A federal judge threw out a lawsuit filed by over 100 Houston Methodist employees. The workers alleged the hospital's COVID-19 vaccine mandate forced them to be "human guinea pigs." The judge said the workers were not being forced or coerced to take a vaccine. See more stories on Insider's business page. A federal judge tossed...
Tags: Lawsuit, Texas, News, US, Trends, Fda, Pfizer, Nazi, Houston, US supreme court, Johnson Johnson, US Food and Drug Administration, Hughes, Jared Woodfill, Houston Methodist Hospital, Houston Methodist


Top stories this PM: 60 million wasted doses; a new Trump probe; Biden's gift to Boris

Good evening. Here are the top stories so far today.For more daily and weekly briefings, sign up for our newsletters here.What happened today:60 million doses down the drain. The FDA said Johnson & Johnson must throw out that many COVID-19 vaccine doses because of possible contamination. They were made at a Baltimore factory that's been closed for two months after workers accidentally mixed up ingredients.Probing "a gross abuse of power." The deputy attorney general asked the Justice Departm...
Tags: Apple, Europe, Texas, News, Mexico, Senate, White House, Newsletter, Trends, Joe Biden, Ap, Boris Johnson, Fda, Bmw, Biden, Nissan


Doctor says FDA decision was so egregious he resigned

CNN's Ana Cabrera speaks with Dr. Joel Perlmutter about his decision to resign from an FDA panel over the agency's approval of the controversial drug aducanumab to treat Alzheimer's.
Tags: News, Cnn, Stories, Fda, Ana Cabrera, Joel Perlmutter


FDA authorizes two batches of Johnson & Johnson Covid-19 vaccine doses from Baltimore plant

The US Food and Drug Administration announced Friday it was authorizing for use two batches of Johnson & Johnson Covid-19 vaccines that were produced at the troubled Emergent BioSolutions facility in Baltimore.
Tags: Cnn, Fda, Johnson, Baltimore, US Food and Drug Administration, Johnson Covid, Johnson Johnson Covid


FDA Adviser Quits Over ‘Probably The Worst Drug Approval In Recent U.S. History’

The controversial Alzheimer's drug costs $56,000 a year and some patients could face copayments of $11,500 annually.
Tags: News, Fda


US nears 600K deaths as variants increase; Reports: FDA rules millions of doses of J&J vaccine must be discarded: COVID-19 updates

While United States will enter the summer with some of the lowest COVID case rates in months, the country nears 600,000 deaths. Latest COVID news.       [Author: USA TODAY]
Tags: Usa, News, US, United States, Fda, Usa Today


FDA preparing to clear roughly 10 million Johnson & Johnson Covid-19 vaccine doses

The Food and Drug Administration is preparing to clear two batches of Johnson & Johnson Covid-19 vaccines that were produced at the troubled Emergent facility in Baltimore, a source familiar with the plans told CNN.
Tags: Cnn, Food And Drug Administration, Fda, Johnson, Baltimore, Johnson Covid, Johnson Johnson Covid


Top Stories this AM: A tentative infrastructure deal is struck; a COVID outbreak at a maskless crypto conference; elf ears are in

Good morning and welcome to your weekday morning roundup of the top stories you need to know.For more daily and weekly briefings, sign up for our newsletters here.What's going on today: Infrastructure - we've got it? Bipartisan Senate group strike early $1.2 trillion infrastructure agreement as Democrats grow impatient. The tentative deal faces a steep climb in both parties. Democrats want tax hikes, while Republicans are likely to balk at fresh spending. Ears the thing. People in China ...
Tags: News, China, US, Newsletter, Trends, Miami, Fda, Biden, Miller, Trump, Biogen, Jason Miller, Aaron Kesselheim, Bipartisan Senate, Longtime Trump, Top Stories This Am


The US government is blocking states from ordering Johnson & Johnson's COVID-19 vaccine so they can clear their backlog of unused doses

A clinical trial volunteer participates in Johnson & Johnson's study to test a coronavirus vaccine. Janssen The government has blocked any shipments of Johnson & Johnson's vaccine, health officials told the WSJ. States already have stockpiles of the single-dose J&J shot, and vaccination rates are falling. Millions of J&J vaccines are due to expire this month. See more stories on Insider's business page. The US government is stopping orders of Johnson & Johnson COVID-19 vaccines...
Tags: Politics, News, Cdc, White House, US, Trends, Joe Biden, Healthcare, Fda, Vaccine, Oklahoma, Johnson, Illinois, Journal, Johnson & Johnson, Food and Drug Administration FDA


A third member of a prestigious FDA panel has resigned over the approval of a controversial new Alzheimer's drug

Atthapon Raksthaput/Shutterstock A third member of an FDA expert panel has resigned over the agency's accelerated approval of a new Alzheimer's drug. The committee voted against approving the treatment. The FDA isn't required to follow the panel's recommendation but usually does. Aduhelm failed one of its late-stage clinical trials and didn't produce conclusive results in another trial. See more stories on Insider's business page. A third member of a Food and Drug...
Tags: Science, News, US, Trends, Healthcare, Food And Drug Administration, Alzheimer's, Fda, Mayo Clinic, Cnbc, Harvard Medical School, Biogen, Washington University in St Louis, Aaron Kesselheim, Knopman, Kesselheim


United States: FDA's Unapproved Drugs Initiative Revived, With Gusto! - Mintz

Although we've now entered June of 2021 and President Biden has yet to nominate someone to serve as the Commissioner of Food and Drugs.
Tags: News, United States, Fda, Biden, Mintz


FDA's vaccine advisers debate urgency of vaccinating kids against coronavirus

Vaccine advisers to the US FDA debated what kind of detailed information the agency would need to consider authorizing the use of coronavirus vaccines in children under age 12 on Thursday.
Tags: US, Cnn, Fda


Moderna seeks FDA approval to vaccinate kids 12-17; J&J vaccine has longer shelf life; Pfizer donates 500M doses: Live COVID-19 updates

Moderna said it has requested an "emergency use authorization" to vaccinate kids as young as 12. Latest COVID-19 news.       [Author: USA TODAY]
Tags: Usa, News, Fda, Pfizer, Usa Today, Moderna


As some doses approach expiration, FDA extends shelf life for Johnson & Johnson vaccine

The US Food and Drug Administration authorized an extension of the shelf life of Johnson & Johnson's Covid-19 vaccine, the company said in a statement Thursday.
Tags: Cnn, Fda, Johnson, Johnson Johnson, US Food and Drug Administration, COVID


U.S. Officials Extend Expiration Dates On Johnson & Johnson Vaccine Doses

It comes after an FDA review found the shots remained safe and effective for an extra six weeks.
Tags: News, Fda, Johnson


Moderna seeks FDA approval to vaccinate kids as young as 12; Pfizer to donate 500M doses for low-income countries: Live COVID-19 updates

Ohio has two more Vax-a-Million winners. California withdraws controversial masking rules for vaccinated employees. The latest COVID-19 updates.       [Author: USA TODAY]
Tags: Usa, News, California, Ohio, Fda, Pfizer, Usa Today, Moderna


Moderna seeks FDA authorization for Covid-19 vaccine for people ages 12 to 17

Moderna has filed with the US Food and Drug Administration for emergency use authorization for its Covid-19 vaccine for people ages 12 to 17, according to a news release from the company.
Tags: Cnn, Fda, US Food and Drug Administration, Moderna


A “disgraceful decision:” Researchers blast FDA for approving Alzheimer’s drug (ars technica)

Enlarge (credit: Getty | Congressional Quarterly) The US Food and Drug Administration on Monday approved the antibody drug Aduhelm (generic name aducanumab) to treat Alzheimer’s disease. Aduhelm is the first new Alzheimer’s drug to earn FDA approval since 2003. It’s also the first drug to target a theoretical cause of the irreversible neurodegenerative disease—clumps of beta-amyloid peptides that build up in the brains of Alzheimer's patients—rather than just treating the disease’s symptoms. T...
Tags: News, US, Fda, Beth Mole, US Food and Drug Administration, Biogen, Aduhelm


FDA adviser resigns over approval of new Alzheimer's drug

A member of an FDA advisory committee said Wednesday he had resigned over the agency's approval of a new Alzheimer's drug.
Tags: Cnn, Fda


Johnson & Johnson Doses At Risk Of Expiring As FDA Mulls Extension

The FDA's decision to pause distribution of the one-dose vaccine is credited with damaging its reputation in the U.S.
Tags: News, Fda, Johnson


Johnson & Johnson COVID-19 Vaccine Doses At Risk Of Expiring As FDA Mulls Extension

The FDA's decision to pause distribution of the one-dose vaccine is credited with damaging its reputation in the U.S.
Tags: News, Fda, Johnson


United States: FDA Considers Petition To Ban PFAS Food Uses, As Companies Move Toward Phase-Out - Kelley Drye & Warren LLP

A coalition of environmental, food safety, and consumer health advocacy groups petitioned the U.S. Food and Drug Administration (FDA) yesterday to ban per- and poly-fluoroalkyl substances (PFAS) from food contact uses.
Tags: News, United States, Fda, U S Food and Drug Administration FDA, Kelley Drye, Warren LLP



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