Even those who supported the F.D.A.’s approval of the controversial new drug said authorizing it for anyone with Alzheimer’s disease was much too broad.
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Tag Archives: Clinical Trials
Wondering if the Covid Vaccine Worked? Get the Right Test, at the Right Time
Scientists generally recommend against antibody testing after vaccination. But for some people, it makes sense.
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A Pill to Treat Covid-19? The U.S. Is Betting on It.
A new $3.2 billion program will support the development of antiviral pills, which could start arriving by the end of this year.
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CureVac’s Covid Vaccine Performed Badly in Trial, In Part Due to Variants
The results were a blow to hopes that the vaccine could help meet the world’s urgent need. “This is pretty devastating” for the company, one expert said.
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Novavax Offers U.S. a Fourth Strong Covid-19 Vaccine
The company’s large U.S. trial found an efficacy rate of about 90 percent. But at this point, the nation is awash in other shots.
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Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug
The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients.
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Chicken Soup Can’t Treat Depression. Welcome to My TED Talk.
A myopic but seductive worldview has caught on among many influential people — and it might be hindering our ability to solve real-world problems.
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A “disgraceful decision:” Researchers blast FDA for approving Alzheimer’s drug
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.
The approval is, without a doubt, a landmark. It could provide hope to millions of patients, who currently have few options. And, given those limited options, it will certainly provide a massive money-maker for its developer, Biogen, which has already set the list price for a year’s worth of Aduhelm at $56,000. Analysists estimate that the drug will bring in $5 billion to $6 billion worth of sales per year in the US alone.
But, the FDA’s approval is far from a celebrated decision and the drug is far from a clear success. Since the FDA’s approval yesterday, researchers and pharma watchers have called the agency’s decision “disgraceful,” “a grave error” and a “dangerous precedent” that will end up “eroding confidence in the agency as a whole.”
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Alzheimer’s Drug Is Bonanza for Biogen, Most Likely at Taxpayer Expense
Despite scant evidence that it works, the drug, Aduhelm, is predicted to generate billions of dollars in revenue, much of it from Medicare.
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We’ll Probably Need Booster Shots for Covid-19. But When? And Which Ones?
Scientists are asking a lot of questions about Covid-19 booster shots, but they don’t yet have many answers. Here’s what they know so far.
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Alzheimer’s Drug Poses a Dilemma for the F.D.A.
If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say there isn’t enough evidence it works.
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Early analysis suggests that another mRNA vaccine is safe, but its effectiveness isn’t yet known.
The German company CureVac is developing an RNA vaccine that could be substantially cheaper than Moderna or Pfizer.
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People Want an Alzheimer’s Drug. Aducanumab Isn’t the One.
An F.D.A. sign-off for aducanumab would make finding a good treatment harder.
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Moderna Vaccine Highly Effective in Adolescents, Company Says
The U.S., which has a surplus of vaccines, could soon have two options for teens while many countries face shortages.
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In the Race for a Covid-19 Pill, a Little Lab Plays a Big Role
The Big Pharma drug model is inefficient and unsustainable. There is an alternative.
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Why the C.D.C. Changed Its Advice on Masks
Two scientific findings altered the calculus: Vaccinated people don’t transmit the virus, and the shots are effective against variants.
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Pfizer and Moderna Shots Are Powerfully Effective Against Covid, Analysis Says
A new study of 1,800 health care workers confirms that the vaccines are working well in the real world, outside clinical trials.
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New Drugs Could Help Treat Obesity. Could They End the Stigma, Too?
The hope is that new treatments will encourage people to think of obesity as a chronic disease, like high blood pressure or diabetes.
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FDA Authorizes Pfizer-BioNTech Vaccine for Children 12 to 15
The shots may allow millions of youngsters to get back to school, camps, sleepovers and hangouts with friends.
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This New Covid Vaccine Could Bring Hope to the Unvaccinated World
The German company CureVac hopes its RNA vaccine will rival those made by Moderna and Pfizer-BioNTech. It could be ready next month.
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FDA Set to Authorize Pfizer Vaccine for Adolescents by Early Next Week
The U.S. vaccination campaign will soon expand to millions more people, but public health experts say the move raises complicated questions about supply and access.
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MDMA Reaches Next Step Toward Approval for Treatment
A new study shows that MDMA, known as Ecstasy or Molly, can bring relief when paired with talk therapy to those with severe post-traumatic stress disorder.
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They Have Alzheimer’s. This Clinical Trial May Be a Last Hope.
In the narrow window in which patients are aware of their disease, they have sought help in clinical trials. But enrolling enough participants to make these trials count is not easy.
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No, We Don’t Know if Coronavirus Vaccines Affect Periods
We do know that researchers do not study menstruation enough.
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The Covid-19 Plasma Boom Is Over. What Did We Learn From It?
The U.S. government invested $800 million in plasma when the country was desperate for Covid-19 treatments. A year later, the program has fizzled.
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Can the Covid Vaccine Protect Me Against Virus Variants?
Vaccines do a good job of protecting us from coronavirus, but fear and confusion about the rise of variants have muddled the message. Here are answers to common questions.
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Joe Biden Made a Promise to Scientists. He Can Still Keep It.
Researchers who receive federal help consistently fail to report their results to the public. The government should hold them accountable.
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Researchers Are Hatching a Low-Cost Coronavirus Vaccine
A new formulation entering clinical trials in Brazil, Mexico, Thailand and Vietnam could change how the world fights the pandemic.
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Researchers Are Hatching a Low-Cost Covid-19 Vaccine
A new formulation entering clinical trials in Brazil, Mexico, Thailand and Vietnam could change how the world fights the pandemic.
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Covid-19 Vaccine Side Effects: Your Questions Answered
The most common questions about vaccination side effects, answered.
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Can Vaccinated People Spread the Virus? We Don’t Know, Scientists Say.
Researchers pushed back after the C.D.C. director asserted that vaccinated people “do not carry the virus.”
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A ‘Game Changer’ for Patients With Esophageal Cancer
A drug that unleashes the immune system offers a rare glimmer of hope for those with a cancer that resists most treatments.
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The Pfizer-BioNTech Vaccine Is Said to Be Powerfully Protective in Adolescents
A clinical trial found no symptomatic infections among vaccinated children ages 12 to 15, the companies said, and there were no serious side effects. The data have not yet been reviewed by independent experts.
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Getting One Vaccine Is Good. How About Mix-and-Match?
Researchers are exploring the possible benefits of pairing doses from two different Covid-19 vaccines.
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We Need to Vaccinate Kids Against Covid-19
So far, children have mostly been spared from the worst aspects of Covid-19. Let’s keep it that way.
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Pfizer Begins Testing Its Vaccine in Young Children
Other drug makers have begun similar trials of their Covid-19 vaccines. If they work in children younger than 12 as expected, it will be easier for the U.S. to reach herd immunity.
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Vaccinated People Can Get Covid, but It’s Most Likely Very Rare
“Breakthrough” cases, though quite uncommon, are a sharp reminder that vaccinated people should wear masks while the virus is circulating widely.
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AstraZeneca’s Covid-19 Vaccine Found to Be 79% Effective in U.S. Study
The vaccine maker is preparing to apply for emergency authorization from the Food and Drug Administration. But the vaccine may not be needed in the United States.
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Europe’s Vaccine Ethics Call: Do No Harm and Let More Die?
Ethicists are worried about the gamble Germany took to halt AstraZeneca doses over seven cases of blood clots. It will not be the last time hard decisions are made in this pandemic.
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Moderna Starts Testing Its Covid Vaccine in Babies and Young Children
The company will study its vaccine in children ages six months through 11 in the United States and Canada.
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The AstraZeneca Vaccine: Should You Be Concerned?
There is no evidence so far of a link between the AstraZeneca shots and a few new cases in Europe of serious illness and deaths. But investigations are underway.
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Can the World Learn From South Africa’s Vaccine Trials?
Vaccine trials are often done in wealthier countries. Scientists say the South Africa experience proves the value of trials in the global south.
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Nobody Wants Cancer. But a ‘Big C’ Label Has Surprising Upsides.
Classifying a rare blood disorder as a cancer opened new doors for disease investigation, treatment and hope for a cure.
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The U.S. Is Sitting on Tens of Millions of Vaccine Doses the World Needs
Those tens of millions of doses from AstraZeneca are waiting for trial results, while countries that authorized the vaccine beg to have them.
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Sickle Cell Treatment Not Linked to Cancer, Researchers Say
Trials of experimental gene therapy for sickle cell disease were halted when patients developed worrying illnesses.
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Women Report Worse Side Effects After a Covid Vaccine
Men and women tend to respond differently to many kinds of vaccines. That’s probably because of a mix of factors, including hormones, genes and the dosing of the shots.
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As Covid Deaths Soar in Brazil, Bolsonaro Hails an Untested Nasal Spray
Vaccines and critical-care beds are in short supply. Yet President Jair Bolsonaro is railing against social distancing and calling an experimental treatment from Israel “miraculous.”
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In Oregon, Scientists Find a Virus Variant With a Worrying Mutation
In a single sample, geneticists discovered a version of the coronavirus first identified in Britain with a mutation originally reported in South Africa.
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India’s Covaxin Covid-19 Vaccine, Already in Use, Shows Promise in Trials
Interim results from clinical trials suggested that Covaxin could be safe and effective, potentially removing one hurdle to New Delhi’s ambitious campaign to inoculate a vast population.
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Plan to Ditch the Mask After Vaccination? Not So Fast.
It’s not clear how easily vaccinated people may spread the virus, but the answer to that question is coming soon. Until then, scientists urge caution.
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