Posts filtered by tags: Food And Drug Administration[x]


 

MyPillow CEO Mike Lindell said he lost $7 million making COVID-19 masks in the operation he announced alongside Trump

My Pillow CEO Mike Lindell speaks as President Donald Trump listens during a briefing about the coronavirus in the Rose Garden of the White House, Monday, March 30, 2020, in Washington. Alex Brandon/AP Last year, MyPillow CEO Mike Lindell said his company would make and donate COVID-19 masks. Lindell told The Daily Beast he lost $7 million on the effort and has millions of masks left over. "I can't give them away," Lindell told The Daily Beast. "No one wants the things anymore." See mo...
Tags: Politics, Minnesota, Washington, White House, Masks, US, Trends, Food And Drug Administration, Donald Trump, The Daily Beast, Trump, Lindell, Rose Garden, Daily Beast, Alex Brandon, Jacob Shamsian


mRNA Companies are Now Testing Cancer-Fighting Vaccines

USA Today reports: Companies like Moderna and Pfizer's partner BioNTech, whose names are familiar from COVID-19 vaccines, are using mRNA to spur cancer patients' bodies to make vaccines that will — hopefully — prevent recurrences and treatments designed to fight off advanced tumors. If they prove effective, which won't be known for at least another year or two, they could be added to the arsenal of immune therapies designed to get the body to fight off its own tumors... Over the last decade, ...
Tags: Europe, Tech, Merck, Food And Drug Administration, Pfizer, Usa Today, Regeneron, United Kingdom Australia, Moderna, Stephen Hahn, COVID, Melissa J Moore Moderna


The US is scrambling to send promised vaccines abroad after the production plant that ruined millions of J&J vaccines may have tainted AstraZeneca shots

A person receives the AstraZeneca vaccine in Bologna, Italy on March 19, 2021. Michele Lapini/Getty Images Emergent BioSolutions in Baltimore ruined at least 15 million Johnson & Johnson vaccines earlier this year. 100 million AstraZeneca and Johnson & Johnson vaccines from the facility are under safety review. The US is scrambling to send vaccines from other manufacturers abroad, The New York Times reported. See more stories on Insider's business page. The US is working to replace ...
Tags: Science, US, Trends, New York Times, The Times, Food And Drug Administration, Astrazeneca, Fda, Pfizer, Biden, Baltimore, Johnson Johnson, Bologna Italy, Moderna, Coronavirus, Sarah Al Arshani


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


One year or 5? Doctors and drug companies increasingly disagree about when we'll need COVID-19 booster shots

Marianne Ayala/Insider Booster shots may not be medically necessary for another one to five years, disease experts wager. But pharmaceutical companies are prepping to distribute boosters to the US before the end of 2021. In either case, boosters probably won't require the same urgency as initial vaccines do. See more stories on Insider's business page. The next vaccine race is underway - this time for booster shots.Leading vaccine developers, including Pfizer, Moderna, and Novavax...
Tags: Science, News, Cdc, White House, Israel, US, Trends, UPS, Healthcare, Food And Drug Administration, Philadelphia, Goldman Sachs, Pfizer, Anthony Fauci, Centers For Disease Control And Prevention, Cornell University


Covid live: UK reports 9,055 new cases – highest daily total since February; France and Spain ease mask-wearing

UK reports nine deaths amid highest new cases since February; France to also bring curfew-lifting date forwardFrance and Spain ease mask-wearing as vaccine schemes gather paceNew drug cuts deaths among patients with no Covid antibodiesJapan could allow up to 10,000 spectators at Tokyo Olympic eventsUK again excluded from EU’s Covid-safe travel list, but US addedUK coronavirus updates – live 5.27pm BST Russian’s Sputnik Covid jab has not yet been approved by Thai regulators as important data ...
Tags: UK, France, US, Eu, Spain, World news, Thailand, Food And Drug Administration, Tokyo, Associated Press, Vaccines and immunisation, Ecuador, Quito, UCI, Vallejo, Quito Ecuador


Novavax climbs 9% after clinical trial shows the firm's COVID-19 vaccine is 90% effective

Jane Tyska/Digital First Media/East Bay Times via Getty Images Novavax shares climbed as much as 9% on Monday following the biotech firm's upbeat data about its potential COVID-19 vaccine. The study of nearly 30,000 people in the US and Mexico produced an overall efficacy rate of 90.4%. The company is aiming to file for FDA approval in the third quarter of this year. See more stories on Insider's business page. Novavax shares climbed as much as 9% on Monday after the company sa...
Tags: New York, Mexico, Amc, US, Trends, Markets, Research and development, Food And Drug Administration, Fda, Novavax, Carla Mozee, Jane Tyska, Coronavirus, COVID-19, COVID, Covid-19 Vaccine


Southern California hospitals don’t require vaccines as condition of employment

By Fred Shuster, City News Service LOS ANGELES >> While some hospitals in other parts of the country face pushback from employees over mandatory COVID-19 vaccination policies, hospitals in Los Angeles and Orange counties have largely avoided the issue, with hospital representatives telling City News Service they aren’t requiring workers to get the vaccine. The uproar from some hospital employees gained national attention this week, when the Houston Methodist hospital system in Texas suspended 17...
Tags: Texas, News, Maryland, California, Washington, Los Angeles, Sport, Hospitals, Soccer, Pennsylvania, Healthcare, Food And Drug Administration, Houston, Local News, Orange, University Of California


Justice department watchdog launches inquiry into seizure of Democrats’ data – as it happened

Congress members’ phone records targeted by Trump DoJ Schumer calls for Barr and Sessions to testify before SenateTrump DoJ secretly seized House Democrats’ data in crackdown on leaks 1.01am BST That’s all from me today! Here’s a rundown of the day’s biggest politics stories: 12.36am BST The Food and Drug Administration will require at least 60m doses of the Johnson & Johnson coronavirus vaccine to be discarded due to problems at a factory, the Washington Post reports. The spoiled doses...
Tags: Republicans, Congress, Washington Post, Joe Biden, US news, Democrats, US politics, House, Food And Drug Administration, Donald Trump, Baltimore, Trump, Johnson Johnson, Schumer, Barr


What a controversial drug approval could mean for future Alzheimer's treatments

Hello,Welcome to Insider Healthcare. I'm Lydia Ramsey Pflanzer, and this week in healthcare news:A controversial Alzheimer's drug approval poses some big challenges for the future of the field;We chronicled the history of Noom, which raised $540 million from top investors after spending a decade trying to crack the weight-loss app business;Amazon and Walmart face off on discounting prescriptions.If you're new to this newsletter, sign up here. Tips, comments? Email me at [email protected]
Tags: Amazon, Newsletter, Trends, Walmart, Alzheimer's Disease, Healthcare, Food And Drug Administration, Fda, Morgan Stanley, Silver Lake, Pharmacy, Shelby, Megan, Allison, Gabby, Biogen


Johnson & Johnson has to throw away 60 million vaccine doses because of possible contamination at the beleaguered Emergent BioSolutions plant

Michael Ciaglo/Getty Images The Food and Drug Administration has told Johnson & Johnson to throw out about 60 million COVID-19 vaccine doses from a beleaguered plant, people familiar with the situation told The New York Times.The vaccine doses were made at a factory for Emergent BioSolutions, a biotech firm that's known for producing anthrax vaccines.The factory has been closed for two months because of regulatory concerns after Emergent BioSolutions discovered that workers had acciden...
Tags: Science, Trends, Food And Drug Administration, The New York Times, Vaccine, Johnson, Johnson & Johnson, Kelly McLaughlin, Coronavirus, COVID-19, Covid-19 Vaccine, Michael Ciaglo Getty, Johnson & Johnson vaccine, Speed desk


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


Young people are experiencing rare cases of heart inflammation after getting coronavirus vaccines, but doctors say the risk of COVID-19 is far greater

Pfizer BioNTech's COVID-19 vaccine at Desert Valley Hospital. Irfan Khan / Los Angeles Times via Getty Images Young people who receive COVID-19 vaccines are reporting higher rates of heart inflammation, a possible side effect. The CDC is investigating a potential link between Pfizer and Moderna shots and these events. Even if there is a link, doctors said the risk is far greater from COVID-19 than from the vaccines. See more stories on Insider's business page. Young people who rece...
Tags: Cdc, Israel, US, Trends, Food And Drug Administration, University of Pennsylvania, Pfizer, Centers For Disease Control And Prevention, Rubin, Northwell Health, Paul Hennessy, Melbourne Florida, Cohen Children s Medical Center, Moderna, Andrew Dunn, COVID


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


CDC To Meet On Rare Heart Inflammation Following COVID Vaccine

An anonymous reader quotes a report from Reuters: The Centers for Disease Control and Prevention announced Thursday that will convene an "emergency meeting" of its advisers on June 18th to discuss rare but higher-than-expected reports of heart inflammation following doses of the mRNA-based Pfizer and Moderna COVID-19 vaccines. So far, the CDC has identified 226 reports that might meet the agency's "working case definition" of myocarditis and pericarditis following the shots, the agency disclosed...
Tags: Cdc, Israel, Tech, Food And Drug Administration, Pfizer, Centers For Disease Control And Prevention, Reuters, U S Department of Defense, Moderna, Shimabukuro, Tom Shimabukuro


US extends expiration date on Johnson & Johnson vaccine

By Matthew Perrone | Associated Press WASHINGTON — Johnson & Johnson said Thursday that U.S. regulators extended the expiration date on millions of doses of its COVID-19 vaccine by six weeks. The company said a Food and Drug Administration review concluded the shots remain safe and effective for at least 4 1/2 months. In February, the FDA originally authorized J&J’s vaccine for up to three months when stored at normal refrigeration levels. Thursday’s announcement comes after state officials warn...
Tags: Business, News, Cdc, Washington, US, Sport, World news, Joe Biden, Soccer, Food And Drug Administration, Fda, Associated Press, Pfizer, Johnson, Biden, Baltimore


COVID-19 vaccines could be available for kids as young as 6 months old starting this fall

Dado Ruvic/Reuters Pfizer and Moderna said they could have COVID-19 vaccines for kids as young as 6 months by the fall. Pfizer told The New York Times it would start testing its vaccine in infants in the next few weeks. See more stories on Insider's business page. COVID-19 vaccines could be available for children as young as 6 months in the US by the fall, Pfizer and Moderna told The New York Times on Tuesday.Pfizer announced on Tuesday that it was testing its COVID-19 vaccine in 5- t...
Tags: Science, News, US, Trends, Healthcare, The Times, Food And Drug Administration, Fda, Pfizer, The New York Times, Moderna, Stéphane Bancel, Coronavirus, Bancel, COVID-19, Covid-19 Vaccine


10 Things in Politics: Trump haunts Biden's DOJ

Welcome back to 10 Things in Politics. Sign up here to receive this newsletter. Send tips to [email protected] or tweet me at @BrentGriffiths.No that's not rain; it's cicadas.Here's what we're talking about:Trump may be gone, but his administration's legacy hangs over the Justice DepartmentVice President Harris told Guatemalan migrants 'do not come' to the USThese are the 7 federal judges helping to decide the fate of the Capitol riotersOne thing to watch for: Co...
Tags: Amazon, Post, Washington, Senate, Russia, US, Trends, Georgia, Bloomberg, Joe Biden, Cnn, Getty Images, Canada, Philippines, House, The Times


US stocks move lower as investors see hotter inflation and higher rates on the horizon

A trader on the floor of the New York Stock Exchange. JOHANNES EISELE/AFP via Getty Images The S&P 500 and the Dow Jones Industrial Average turned lower during Monday's session. Investors are anticipating the consumer price inflation reading for May to accelerate from an already multi-year high. A rally in shares of so-called meme stock AMC resumed. See more stories on Insider's business page. US stocks mostly moved lower Monday as investors prepared to see a potential kick high...
Tags: China, Amc, US, Trends, Markets, Tesla, Economy, Food And Drug Administration, Treasury, Stocks, Janet Yellen, US Treasury, West Texas Intermediate, Republican, S&P 500, Dow Jones Industrial Average


FDA Approves Alzheimer's Drug Despite Fierce Debate Over Whether It Works

The Food and Drug Administration on Monday approved the first new medication for Alzheimer's disease in nearly two decades, a contentious decision, made despite opposition from the agency's independent advisory committee and some Alzheimer's experts who said there was not enough evidence that the drug can help patients. From a report: The drug, aducanumab, which will go by the brand name Aduhelm, is a monthly intravenous infusion intended to slow cognitive decline in people with mild memory and ...
Tags: Tech, Food And Drug Administration, Fda, Biogen


The FDA Just Approved a Controversial Alzheimer's Drug

The Food and Drug Administration on Monday approved the drug aducanumab as a treatment for Alzheimer’s disease, the first ever intended to slow the progression of the incurable dementia. The go-ahead marks a rare case in which the FDA went against the recommendations of the outside panel it solicited for advice, who…Read more...
Tags: Health, Science, Food And Drug Administration, Fda, Life Sciences, Biogen, Pharmaceutical Industry, Drug Discovery, Aducanumab, Clinical Trial, Alzheimers Disease, Health Sciences, FDA Drug, Monoclonal Antibodies, Maria Carrillo, Health Medical Pharma


The FDA just approved the first new Alzheimer's drug in 18 years

Dr. William Burke going over a PET brain scan at Banner Alzheimer's Institute in Phoenix. Biogen's drug was tested against carriers of the APOE gene, which is linked to Alzheimer's, and non-carriers. Matt York/Associated Press The FDA on Monday approved the first new Alzheimer's disease treatment in nearly two decades. Biogen had initially deemed the drug a failure and shut down two late-stage trials. Experts were divided on the drug. One analyst had estimated a 15% chance ...
Tags: Science, News, Trends, Alzheimer's Disease, Healthcare, Food And Drug Administration, Fda, Biotech, Agency, Citi, Alzheimer, William Burke, RBC Capital Markets, Biogen, Eli Lilly, Namenda


COVID-19: THE SYSTEM, Part 2

In Part 1 we ended with the documentary’s discussion of the type of business model that has been created around COVID-19, or to match the title of the film, a system. The system consists of interlocking and mutually enforcing actors, institutions, and processes: Government, working in tandem with establishment scientists, transnational business interests and the […]
Tags: Debt, Austerity, European Union, Canada, Bill Gates, Anthropology, Income Inequality, Food And Drug Administration, Who, World Health Organization, Astrazeneca, Fda, Pfizer, Authoritarianism, Anthony Fauci, Quebec


FDA Approves 'Game Changer' Weight Loss Drug, Likely First in a New Era of Obesity Treatment (gizmodo)

On Friday, the Food and Drug Administration approved a new injectable medication for treating obesity—one shown to help people lose a significant amount of weight in clinical trials when taken regularly. The drug, called Wegovy, may just signal a new era in obesity treatment.Read more... [Author: Ed Cara]
Tags: News, Food And Drug Administration, Fda, Ed Cara, Wegovy


FDA Approves 'Game Changer' Weight Loss Drug, Likely First in a New Era of Obesity Treatment

On Friday, the Food and Drug Administration approved a new injectable medication for treating obesity—one shown to help people lose a significant amount of weight in clinical trials when taken regularly. The drug, called Wegovy, may just signal a new era in obesity treatment.Read more...
Tags: Science, Medicine, Obesity, Diabetes, Food And Drug Administration, Fda, Novo Nordisk, Bariatric Surgery, Donna Ryan, Semaglutide, Clinical Medicine, Medical Specialties, Hospitality Recreation, Health Medical Pharma, Glucagon Like Peptide 1, Anti Diabetic Drugs


Fate of Biogen’s Stock Rides on Alzheimer’s Drug Decision

(Bloomberg) -- For Biogen Inc., the Food and Drug Administration’s expected decision Monday on its Alzheimer’s drug is what a JPMorgan...
Tags: Food And Drug Administration, Biogen, Bloomberg For Biogen Inc


FDA weighs approval of a lucrative Alzheimer’s drug but benefits are iffy

The Food and Drug Administration's decision next week whether to approve the first treatment for Alzheimer's disease highlights a deep division over the drug's benefits as well as criticism about the integrity of the FDA approval process.
Tags: Health, Food And Drug Administration, Fda


Why Scientists Are Worried About a New Alzheimer's Drug Up for FDA Approval

The fate of an experimental dementia drug will be decided within days. On Monday, the Food and Drug Administration is set to announce whether it will approve Biogen’s antibody-based therapy aducanumab as a treatment for Alzheimer’s disease—the first intended to slow down the progression of the incurable ailment. But…Read more...
Tags: Science, Food And Drug Administration, Life Sciences, Biogen, Mild Cognitive Impairment, Aducanumab, Alzheimers Disease, Health Sciences, Monoclonal Antibodies, Amyloid Beta, Cognitive Disorders, Amyloidosis, Branches Of Biology, Health Medical Pharma, Psychiatric Diagnosis, Neurimmune


People who've had COVID-19 vaccines should get a state-issued 'driver's license' to party, top bioethicist says

COVID-19 vaccine cards from the CDC are bulky, and subject to fraud. Maybe the DMV should be in charge? Leonard Ortiz/MediaNews Group/Orange County Register via Getty Images, Ben Hasty/MediaNews Group/Reading Eagle via Getty Images, Hilary Brueck/Insider The CDC's COVID-19 vaccine cards are subject to fraud, and too big to carry around. A top bioethicist says we should get DMV-style licenses for vaccination, with a QR code. See more stories on Insider's business page. Dr. Ezekiel E...
Tags: New York, Science, Jay Leno, Cdc, White House, US, Trends, Eu, Getty Images, Public Health, DMV, Switzerland, Food And Drug Administration, University of Pennsylvania, Lindsay Lohan, Centers For Disease Control And Prevention


UC San Diego Health offers new immunotherapy treatment for multiple myeloma following FDA approval

Following the Food and Drug Administration's approval, UC San Diego Health is the first designated medical center in San Diego certified to offer a new immunotherapy treatment of multiple myeloma outside of a clinical trial.
Tags: Health, San Diego, Food And Drug Administration, Fda, UC San Diego Health