Two Companies Restart Virus Trials in U.S. After Safety Pauses

AstraZeneca and Johnson & Johnson have restarted their late-stage trials after finding that serious illnesses in a few volunteers appeared not to be related to the vaccines.

#astrazeneca-plc, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #johnsonjohnson, #vaccination-and-immunization, #your-feed-healthcare, #your-feed-science

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Experts Tell F.D.A. It Should Gather More Safety Data on Covid-19 Vaccines

In a highly anticipated meeting of the agency’s vaccine advisory board, some said that the current guidelines, which require two months of safety data after a volunteer has been vaccinated, were not enough.

#coronavirus-2019-ncov, #food-and-drug-administration, #polls-and-public-opinion, #vaccination-and-immunization, #your-feed-healthcare, #your-feed-science

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F.D.A. Approves Remdesivir as First Drug to Treat Covid-19

The move indicated that the drug had cleared more rigorous hurdles since it was given emergency authorization in May.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #gilead-sciences-inc, #remdesivir-drug

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The F.D.A. Wanted to Ban Some Hair Straighteners. It Never Happened.

In 2016, agency scientists deemed hair straighteners containing formaldehyde to be unsafe, according to newly obtained emails.

#beauty-salons, #cosmetics-and-toiletries, #environmental-working-group, #food-and-drug-administration, #formaldehyde, #freedom-of-information-act, #hair, #hazardous-and-toxic-substances, #recalls-and-bans-of-products, #regulation-and-deregulation-of-industry, #your-feed-healthcare, #your-feed-science

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Antibody Treatments, Though Promising, Will Be in Short Supply

All the weak points of American health care — testing delays, communication breakdowns, inequity — are working against this potential treatment.

#antibodies, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #elderly, #eli-lilly-and-company, #food-and-drug-administration, #hospitals, #regeneron-pharmaceuticals-inc, #remdesivir-drug, #your-feed-healthcare, #your-feed-science

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Coronavirus Vaccine: Pfizer Says It Won’t Seek Authorization Before Mid-November

Friday’s announcement represents a shift in tone for the company and its leader, who has repeatedly emphasized the month of October in interviews and public appearances.

#bourla-albert, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #pfizer-inc, #presidential-election-of-2020, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-science

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Drug May Extend A.L.S. Patients’ Lives by Several Months, Study Finds

The two-drug combination invented by college students is one of many potential therapies being tested for this paralyzing fatal condition.

#als-assn, #amylyx-pharmaceuticals-inc, #amyotrophic-lateral-sclerosis, #clinical-trials, #cohen-joshua-b, #drugs-pharmaceuticals, #food-and-drug-administration, #klee-justin, #research, #your-feed-healthcare

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Covid-19 and Beyond: How Trump Has Hurt America’s Health

Downplaying the dangers of the pandemic and politicizing public health measures was grossly negligent and cost untold lives.

#appointments-and-executive-changes, #biden-joseph-r-jr, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #environmental-protection-agency, #food-and-drug-administration, #greenhouse-gas-emissions, #hahn-stephen-m-1960, #new-england-journal-of-medicine, #politics-and-government, #presidential-election-of-2020, #redfield-robert-r, #science-and-technology, #trump-donald-j

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A Rapid Test Offers Hope for Community Screening

In a small study in San Francisco, Abbott’s BinaxNOW identified infectious people nearly as accurately as a P.C.R. test.

#abbott-laboratories, #coronavirus-2019-ncov, #disease-rates, #food-and-drug-administration, #hispanic-americans, #mission-district-san-francisco-calif, #san-francisco-calif, #tests-medical, #united-states, #university-of-california-san-francisco, #your-feed-science

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With Russia’s Coronavirus Vaccine, Putin Jumps Ahead of Trump

As America retreats from world affairs, Russia is promising other nations help on the pandemic.

#clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #general-assembly-un, #putin-vladimir-v, #russia, #trump-donald-j, #united-states-international-relations, #vaccination-and-immunization, #world-health-organization

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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.

#antibodies, #astrazeneca-plc, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #einstein-albert-college-of-medicine, #elderly, #eli-lilly-and-company, #factories-and-manufacturing, #food-and-drug-administration, #immune-system, #nursing-homes, #regeneron-pharmaceuticals-inc, #roche-holding-ag, #sars-severe-acute-respiratory-syndrome, #trump-donald-j, #united-states, #united-states-army-medical-research-institute-of-infectious-diseases, #vaccination-and-immunization, #walker-laura, #your-feed-science

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The First Covid Vaccine Will Not Make Life Normal Again

Come spring, Americans may have their choice of several so-so coronavirus vaccines — with no way of knowing which one is best.

#clinical-trials, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #food-and-drug-administration, #national-institutes-of-health, #placebos, #public-private-sector-cooperation, #research, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-healthcare, #your-feed-science

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Nevada Revokes Halt on Rapid Antigen Testing in Nursing Homes

The reversal came just hours after the federal government threatened the state, calling the prohibition on the tests “illegal.”

#becton-dickinsonco, #coronavirus-2019-ncov, #disease-rates, #food-and-drug-administration, #giroir-brett-p, #health-and-human-services-department, #nevada, #nursing-homes, #quidel-corporation, #tests-medical, #your-feed-health, #your-feed-healthcare, #your-feed-science

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Battered by Trump, Robert Redfield of the C.D.C. Faces Pressure to Speak Out

The agency prides itself on avoiding Washington partisanship. But the White House has successfully pushed the agency to revise guidelines on matters like school reopenings and church gatherings.

#centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #food-and-drug-administration, #medicine-and-health, #redfield-robert-r, #trump-donald-j, #united-states-politics-and-government

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Can Trump Really Speed Approval of Covid Treatments?

Emergency-use authorizations, a formerly obscure corner of regulatory law, have become a centerpiece of the government’s response to the pandemic.

#clinical-trials, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #vaccination-and-immunization, #your-feed-health, #your-feed-healthcare, #your-feed-science

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Supreme Court Won’t Immediately Revive Abortion-Pill Restriction

A federal judge, citing the pandemic, had suspended a federal requirement that women seeking medication abortions pick up a pill in person.

#abortion, #abortion-drugs, #alito-samuel-a-jr, #american-college-of-obstetricians-and-gynecologists, #coronavirus-2019-ncov, #decisions-and-verdicts, #food-and-drug-administration, #pregnancy-and-childbirth, #supreme-court-us, #thomas-clarence, #women-and-girls

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Nevada Halts Use of Rapid Coronavirus Tests in Nursing Homes

Two tests made by Quidel and BD repeatedly delivered false-positive results, prompting the state to stop using them.

#abbott-laboratories, #becton-dickinsonco, #coronavirus-2019-ncov, #elder-care, #elderly, #food-and-drug-administration, #laboratories-and-scientific-equipment, #nevada, #nursing-homes, #tests-medical, #your-feed-health, #your-feed-healthcare, #your-feed-science

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A Dose of Vaccine Reality

The F.D.A. releases guidelines that had been trailed by politics: This is your morning tip sheet.

#coronavirus-2019-ncov, #food-and-drug-administration, #trump-donald-j, #vaccination-and-immunization

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White House Blocks New Coronavirus Vaccine Guidelines

The F.D.A. proposed stricter guidelines for emergency approval of a coronavirus vaccine, but the White House chief of staff objected to provisions that would push approval past Election Day.

#azar-alex-m-ii, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #hahn-stephen-m-1960, #meadows-mark-r-1959, #office-of-management-and-budget-us, #regulation-and-deregulation-of-industry, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-healthcare

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Against the Coronavirus, Imperfect Measures Do the Most Good

Speed and scale may matter more than absolute effectiveness when it comes to tests, masks, treatments and vaccines.

#clinical-trials, #content-type-service, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #deaths-fatalities, #dexamethasone-drug, #disease-rates, #drugs-pharmaceuticals, #food-and-drug-administration, #masks, #protective-clothing-and-gear, #remdesivir-drug, #tests-medical, #united-states, #vaccination-and-immunization

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Ro makes the weight loss product Plenity commercially available to everyone in the U.S.

In what could be the first step in the development of a significant new line of business for the telemedicine prescription provider Ro, the company is finally announcing the general commercial availability of weight loss product, Plenity.

Developed by Gelesis, a biotech company that makes treatments for gastro-intestinal disorders, Plentiy is a weight loss treatment that uses citric acid and cellulose to create a non-toxic paste that makes people feel more full after they ingest it. Taken before meals, the pill becomes a substance that expands to take up about 25% of the stomach, so people eat less.

The product has been approved by the U.S. Food and Drug Administration and is available for a much broader segment of the population than other weight loss products. While most prescription medicines are intended for people who are obese, the Gelesis product is made for people who are overweight, too.

“That’s adults who have a BMI from 25 up to 40. That’s 150 million Americans,” according to Gelesis chief commercial and operating officer, David Pass.

Plenity received FDA approval last April and Gelesis started working with Ro soon after, according to Pass. The idea was to craft a strategy that could get the treatment, which is classified as a medical device and not a drug, in the hands of as many patients as quickly as possible.

For Ro, the agreement with Gelesis is a sign of potential things to come. The company is the exclusive online provider of the Plenity treatment and Ro founder Zachariah Reitano said that there’s an incredible potential to engage in more of these types of deals.

“We would love to be able to partner with pharmaceutical companies to decrease the cost of distribution,” said Reitano. “We were excited to build an exciting treatment solution for weight management. Our high-level mission is to be the patient’s first call.”

With the Gelesis partnership Ro can add another highly desirable treatment to its roster of therapies — and one that can be a contributing factor to increasing the severity of other conditions that the company already provides treatment for, Reitano said. 

“There are a few conditions that we currently treat that are exacerbated by a patient being overweight or obese. People who struggle with weight management will also experience ED. Obesity can lead to heart failure stroke, coronary heart disease, hypetension, depression,” Reitano said. “The breadth of the label is interesting. Only FDA approved with a BMI from 25 to 40. FDA approved treatment have been between 30 and 40. [It] makes the treatment more accessible to a wider variety of people.”

As the only online provider of the treatment, Ro has developed an onboarding process to ensure that the Plenity therapy isn’t abused by people who suffer from eating disorders.

“During our onboarding we not only ask questions to patients about their weight management. There’s a consecutive set of images that need to be uploaded and taken with the provider. That’s something we’ve taken a lot of time and energy to make sure about,” said Reitano. 

Like the other treatments Ro offers, Plenity is a cash pay prescription, because the weight loss treatments aren’t typically covered by insurance, he said.

The benefit of working with an online pharmacy like Ro to provide distribution for a new therapy was obvious to both startups.

“We turned this market on its head by putting the consumer at the heart of everything we do,” said Pass. The treatment costs $98 per month, compared to other therapies or branded medications that could be as much $300 and $350 per month, according to Pass.

One reason that Gelesis is able to reduce the price of the drug is that it won’t have to hire a massive sales force to pitch it. The company has Ro for that.

“Normally you have a pharmaceutical company that would have to hire a sales force and go door to door and it increases the cost of a new drug. [Ro] can make a new, innovative treatment available, like Plenity, available nationwide,” Reitano said. 

#depression, #drugs, #energy, #food-and-drug-administration, #health, #obesity, #officer, #online-pharmacy, #pharmaceutical, #ro, #tc, #telemedicine

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Will Pfizer’s Vaccine Be Ready in October? Here’s Why That’s Unlikely.

Despite slim chances that its vaccine will be ready by October, Pfizer has big incentives to hint that it might be.

#astrazeneca-plc, #bourla-albert, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #johnsonjohnson, #moderna-inc, #pfizer-inc, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-healthcare, #your-feed-science

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Trump’s Stalinist Approach to Science

Bully and ignore the experts, and send in the quacks.

#atlas-scott-w, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #food-and-drug-administration, #stalin-joseph, #trump-donald-j, #united-states-politics-and-government

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New York Will Review Virus Vaccines, Citing Politicization of Process

New York officials do not play a role in the approval of a vaccine, but could delay distribution if they believed the vaccine was not safe.

#coronavirus-2019-ncov, #cuomo-andrew-m, #food-and-drug-administration, #new-york-city, #new-york-state, #vaccination-and-immunization

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F.D.A. Requires Stronger Warning Label for Xanax and Similar Drugs

Benzodiazepines — commonly prescribed for anxiety, insomnia, seizures and panic disorders — are highly addictive and come with health risks, especially when combined with other drugs.

#drug-abuse-and-traffic, #drugs-pharmaceuticals, #food-and-drug-administration, #mental-health-and-disorders, #opioids-and-opiates, #your-feed-healthcare

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F.D.A. to Release Stricter Guidelines for Emergency Vaccine Authorization

The new guidelines underscore the fact that a vaccine is highly unlikely before the election.

#clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-health, #your-feed-healthcare

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In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over F.D.A.

Experts said the memo would make it more difficult for the F.D.A. to issue new rules, but it’s unclear how it would affect the vetting of coronavirus vaccines.

#centers-for-disease-control-and-prevention, #centers-for-medicare-and-medicaid-services, #coronavirus-2019-ncov, #food-and-drug-administration, #regulation-and-deregulation-of-industry, #united-states-politics-and-government

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When Will You Be Able to Get a Coronavirus Vaccine?

Despite the president’s repeated claims that a vaccine will be available in October, scientists, companies and federal officials all say that most people won’t get one until well into next year.

#advisory-committee-on-immunization-practices, #astrazeneca-plc, #centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #johnsonjohnson, #moderna-inc, #novavax-inc, #pfizer-inc, #redfield-robert-r, #shortages, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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Should We Fast-Track a Vaccine for the Coronavirus?

It’s complicated.

#coronavirus-2019-ncov, #food-and-drug-administration, #medicine-and-health, #trump-donald-j, #vaccination-and-immunization

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Vaccine Makers Keep Safety Details Quiet, Alarming Scientists

Researchers say drug companies need to be more open about how vaccine trials are run to reassure Americans who are skittish about getting a coronavirus vaccine.

#astrazeneca-plc, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #krumholz-harlan-m, #moderna-inc, #offit-paul-a, #oxford-university, #pfizer-inc, #research, #trump-donald-j, #vaccination-and-immunization

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Trump Pressed for a Plasma Treatment. Officials Worry, Is a Vaccine Next?

New details of how the president has demanded faster action from health agencies help explain the intensifying concern that he could demand pre-Election Day approval of a vaccine.

#azar-alex-m-ii, #birx-deborah-l, #blood, #clinical-trials, #collins-francis-s, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #health-and-human-services-department, #kushner-jared, #marks-peter, #mayo-clinic, #meadows-mark-r-1959, #national-institutes-of-health, #presidential-election-of-2020, #republican-national-convention, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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The Towering Lies of President Trump

It’s simple. Everything that benefits Mr. Trump is true and everything that inconveniences him is false.

#coronavirus-2019-ncov, #food-and-drug-administration, #hydroxychloroquine-drug, #machiavelli-niccolo, #masks, #presidential-election-of-2020, #republican-national-convention, #republican-party, #rumors-and-misinformation, #the-prince-book, #trump-donald-j, #vaccination-and-immunization, #woodward-bob

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F.D.A. Regulators Publish Rare Self-Defense Amid Rising Vaccine Pressure

A group of career scientists at the Food and Drug Administration vowed that their work would continue unimpeded and independent of political influence.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #trump-donald-j, #united-states-politics-and-government

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Even Big Pharma Is Turning On Trump

The president is the Coronavirus vaccine’s worst hype man.

#biden-joseph-r-jr, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #harris-kamala-d, #presidential-election-of-2020, #regulation-and-deregulation-of-industry, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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Pharma Companies Plan Joint Pledge on Vaccine Safety

The statement is meant to reassure the public that the companies will not seek a premature approval of vaccines under pressure from the Trump administration.

#astrazeneca-plc, #centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #medicine-and-health, #moderna-inc, #pfizer-inc, #presidential-election-of-2020, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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New Treatment for Lou Gehrig’s Disease Shows Promise

A study of their therapy and clinical trials of other experimental treatments are offering glimmers of hope that paralysis from the disorder can be slowed.

#als-assn, #amylyx-pharmaceuticals-inc, #amyotrophic-lateral-sclerosis, #clinical-trials, #cohen-joshua-entrepreneur, #drugs-pharmaceuticals, #food-and-drug-administration, #klee-justin, #koroshetz-walter-j, #national-institute-of-neurological-disorders-and-stroke, #new-england-journal-of-medicine, #research, #your-feed-healthcare

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Backed by Federal Funds, New Virus Tests Are Hitting the Market

Six months into the pandemic and with no coherent national testing strategy, the Trump administration is encouraging private development of an array of faster and cheaper techniques.

#abbott-laboratories, #budgets-and-budgeting, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #fluidigm, #food-and-drug-administration, #giroir-brett-p, #health-and-human-services-department, #national-institutes-of-health, #quidel-corporation, #regulation-and-deregulation-of-industry, #tests-medical, #trump-donald-j, #united-states-politics-and-government

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We Don’t Know Enough About Convalescent Plasma

More than 70,000 Covid-19 patients have received it. We have no idea whether it helps.

#blood, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #placebos, #research, #united-states

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American Clinical Research Needs to Step Up Its Game Against Covid-19

Here’s how: Follow Britain’s example.

#clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #great-britain, #national-health-service, #national-institutes-of-health, #research, #united-states

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Your Coronavirus Test Is Positive. Maybe It Shouldn’t Be.

The usual diagnostic tests may simply be too sensitive and too slow to contain the spread of the virus.

#abbott-laboratories, #centers-for-disease-control-and-prevention, #contact-tracing-public-health, #coronavirus-2019-ncov, #food-and-drug-administration, #laboratories-and-scientific-equipment, #medicine-and-health, #quarantines, #tests-medical, #your-feed-healthcare

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Emily Miller and Another P.R. Expert Ousted At F.D.A. After Blood Plasma Fiasco

The agency’s chief spokeswoman, Emily Miller, was removed from her position just 11 days into the job. And the contract was terminated of a consultant who had advised the F.D.A. chief to correct misleading claims about plasma’s benefits.

#apco-worldwide, #appointments-and-executive-changes, #azar-alex-m-ii, #blood, #convalescent-plasma, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #health-and-human-services-department, #miller-emily-j, #pines-wayne-l, #trump-donald-j, #vaccination-and-immunization

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More of Your Coronavirus Testing Questions, Answered

Our readers sent in smart questions about this thorny issue.

#antibodies, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #food-and-drug-administration, #laboratories-and-scientific-equipment, #tests-medical, #united-states

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The F.D.A. Commissioner’s Fuzzy Math

Stephen Hahn made misleading remarks about a coronavirus treatment. How did that happen?

#coronavirus-2019-ncov, #food-and-drug-administration, #hahn-stephen-m-1960, #national-institutes-of-health, #united-states, #vaccination-and-immunization

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Where We Stand on the Pandemic

As summer draws to a close, four new developments in the treatment and understanding of the coronavirus have arisen in the United States and abroad.

#antibodies, #china, #coronavirus-2019-ncov, #food-and-drug-administration, #health-and-human-services-department, #russia, #united-states

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Politicizing Medical Science Will Cost American Lives

Sowing doubt about the safety of treatments will imperil the fight against coronavirus in the months and years to come.

#centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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