Tag: FDA

FDA Asks for Internal Review of Approval Process for Alzheimer’s Drug

Michigan Star Staff

The U.S. Food and Drug Administration is asking for an internal review of its own approval process that gave a greenlight to a drug to treat Alzhiemer’s, a move that could shed more light on the controversial chain of decision-making that led to the drug’s being okayed for use.

The FDA last month approved drug company BioGen’s product Aduhelm, the first medicine greenlit in the U.S. to slow the cognitive decline of those living with Alzhiemer’s.

Yet that decision was shrouded in controversy: The approval went against the advice of an outside panel of FDA experts and even led to the resignation of several of those experts in protest.

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Fully Vaccinated Do Not Need Booster for Delta Variant, CDC and FDA Say

Michigan Star Staff

Fully vaccinated Americans do not need to receive a booster shot to protect against the Delta variant, the Centers for Disease Control and Prevention and Food and Drug Administration said in a press release.

“People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta,” a joint statement said on Thursday.

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U.S. Government Allocates $3.2 Billion for COVID-19 Antiviral Pills

Michigan Star Staff
Department of Health & Human Services

The Department of Health and Human Services will invest $3.2 billion to develop and manufacture COVID-19 antiviral medicines, it announced Thursday.

The initiative, funded as part of the American Rescue Plan, is designed to accelerate research into antivirals as well as build platforms for urgent response to future viral threats, the Department of Health and Human Services (HHS) said in a statement Thursday. Specifically, the plan expands antiviral clinical trials, forms partnerships between health agencies and pharmaceutical companies, and funds “drug discovery groups” tasked with innovating new antiviral medicines.

“New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” said chief medical adviser Dr. Anthony Fauci in the statement.

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Study Finds Novavax COVID-19 Vaccine 90 Percent Effective

Michigan Star Staff
Doctor preparing COVID-19 Vaccine

Novavax announced on Monday that its two-dose COVID-19 vaccine is 90% effective, according to a press release on Novavax’s website.

The phase-3 trial enrolled 29,960 participants ages 18 and older in the U.S. and Mexico. The study found that 77 of the participants tested positive for COVID-19, with 63 testing positive in the placebo group and 14 in the vaccine group, according to the press release.

“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” Stanley C. Erck, President, and CEO of Novavax said in the press release.

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Pro-Life Groups Accuse FDA of ‘Ignoring the Science’ on at-Home Abortion Drugs

Michigan Star Staff

Pro-life groups are accusing the Food and Drug Administration of “ignoring the science” by removing restrictions that prevented abortion drugs from being delivered by mail.

The national pro-life Susan B. Anthony List (SBA List) and its research and education arm, the Charlotte Lozier Institute (CLI), said Tuesday that the FDA’s decision to remove restrictions on abortion drugs “ignores the risk of increased mortality and morbidity for women taking the abortion pill,” according to an SBA List press release.

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Arizona House Passes Bill Banning Abortions Based on Genetic Abnormality

Michigan Star Staff
Susan B. Anthony List State Policy Director Sue Liebel

The Arizona House passed a bill Thursday that bans abortions based on diagnosis of genetic abnormality, such as Down syndrome.

S.B. 1457 states that the rights of “an unborn child at every stage of development” must be acknowledged and prohibits abortions based on the sex, race, or genetic abnormality of the child. The bill makes exceptions for medical emergencies.

“A person who knowingly” performs such an abortion “is guilty of a class 3 felony,” according to the legislation.

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Factory Mixup Ruins 15 Million Johnson & Johnson Coronavirus Vaccines

Michigan Star Staff
COVID-19 Vaccinations

Workers at a Baltimore plant responsible for producing two separate coronavirus vaccines mistakenly mixed up their respective ingredients, ruining approximately 15 million doses of Johnson & Johnson’s vaccine and pausing all production at the plant, the company confirmed Wednesday.

The facility, run by Emergent BioSolutions, had partnered with both Johnson & Johnson and AstraZeneca to produce vaccines. Federal officials said that the mistake was a result of human error, according to The New York Times, which first reported the mix up that reportedly occurred several weeks ago.

A quality control review “identified one batch of drug substance that did not meet quality standards at Emergent BioSolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine,” Johnson & Johnson said in a statement. “This batch was never advanced to the filling and finishing stages of our manufacturing process.”

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FDA Panel Votes to Recommend Johnson & Johnson’s Coronavirus Vaccine for Emergency Authorization

Michigan Star Staff

The Food and Drug Administration’s vaccine advisory panel voted Friday evening to recommend Johnson & Johnson’s coronavirus vaccine for emergency approval, clearing the way for its authorization, distribution and administration nationwide.

The vote followed hours of the panel live-streaming its process of scouring over data from the pharmaceutical company in order to reaffirm that the vaccine was safe for the millions of Americans who will receive it. The FDA also released the vaccine’s clinical trial data on Wednesday showing that the vaccine was effective in fighting the virus itself.

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Coronavirus Vaccines Can Guard Against New, More Contagious UK Strain, Experts Say

Michigan Star Staff

The two coronavirus vaccines that have been approved for emergency use authorization in the U.S. will be able to combat a new, more contagious strain of the virus in the U.K., experts said Monday.

Vaccines made by pharmaceutical companies Pfizer and Moderna will be effective against the new strain, which is “very similar” to previous strains at the genetic level, University of Washington’s Institute for Health Metrics and Evaluation affiliate assistant professor Vin Gupta told CNBC. The Food and Drug Administration has approved both vaccines for emergency use authorization after large-scale human trials showed efficacy of more than 90%.

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FDA Grants Moderna’s Coronavirus Vaccine Emergency Authorization

Michigan Star Staff

The FDA approved Moderna’s coronavirus vaccine for emergency use Friday, making the United States the first country to have approved two safe and effective vaccines against COVID-19.

Its approval follows a key FDA panel’s overwhelming vote Thursday to endorse the vaccine’s safety and efficacy. The Moderna vaccine’s approval means that its distribution could begin within hours, providing hospitals and long-term care facilities across the country thousands of much-needed doses.

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FDA Authorizes First Over-the-Counter Home Coronavirus Test

Michigan Star Staff

The Food and Drug Administration approved the first over-the-counter, at-home coronavirus test Tuesday.

The test, developed by the Australian company Ellume Limited, is a rapid antigen test that can deliver results in approximately 20 minutes, and works on any patient older than two years of age, the FDA said in its announcement.

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FDA Review Reaffirms Moderna Coronavirus Vaccine’s Safety, Efficacy

Michigan Star Staff

The FDA released data Tuesday reaffirming that Moderna’s coronavirus vaccine is safe and effective in preventing severe cases in adults.

The release is a sign that the vaccine is likely to be granted emergency use from the FDA in the coming days, public health officials said, a critical step in ensuring that millions of Americans can be vaccinated as soon as possible. The FDA released similar data regarding Pfizer’s vaccine just days before it was given emergency approval as well.

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FDA Grants Pfizer Coronavirus Vaccine Emergency Authorization, Launching Nationwide Distribution and Vaccination Effort

Michigan Star Staff

The FDA approved Pfizer’s coronavirus vaccine for emergency use Friday, officially beginning a nationwide mass vaccination effort in an attempt to overcome the coronavirus pandemic.

Its approval follows a key FDA panel’s overwhelming vote to endorse the vaccine’s safety and efficacy. President Donald Trump called for the agency to approve Pfizer’s earlier Friday, telling its director, Dr. Stephen Hahn, to “get the dam vaccines out” as soon as possible.

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FDA Advisory Panel Approves Pfizer Coronavirus Vaccine, Clearing Way for Final Authorization and Distribution

Michigan Star Staff

The FDA’s vaccine advisory panel voted 17-4 to approve Pfizer’s coronavirus vaccine for use, clearing the way for its approval and distribution nationwide.

After scouring over Pfizer’s data during the multi-hour meeting Thursday, the panel ensured that it was safe for the hundreds of million Americans expected to receive it in the coming months and voted to recommend approval. Though the panel’s decision is merely an advisory one, the FDA is expected to heed its recommendation and approve Pfizer’s vaccine as early as Friday.

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Moderna Asks FDA for Emergency Approval of COVID-19 Vaccine, Second Company to Pass Milestone

Michigan Star Staff

Pharmaceutical company Moderna announced Monday that it will submit its coronavirus vaccine to the federal government for emergency use authorization approval.

Moderna said it would ask the Food and Drug Administration (FDA) for approval after its large-scale human trial concluded and showed the company’s vaccine to have an overall efficacy of 94.1%, according to NBC News. The vaccine was found to be 100% effective in preventing severe cases of coronavirus, according to Moderna.

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FDA Has Delayed Approval Process for Promising Cancer Drug for Months Because of COVID

Michigan Star Staff

A promising immunotherapy drug for patients battling non-Hodgkin’s lymphoma may fail to gain federal approval due to COVID-19 precautions, according to company executives and a quarterly report.

Liso-cel, manufactured by Bristol-Myers Squibb, originally had its Food and Drug Administration (FDA) application accepted in February, but has yet to have one of its contracted manufacturing sites undergo FDA inspection due to the coronavirus pandemic. Not only is the drug’s approval contingent on the facility inspections from the FDA, according to multiple company executives, but its application expires on Nov. 16, meaning that if the plant is not inspected in the coming days Bristol-Myers may have to completely resubmit the drug’s application as a result.

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AstraZeneca, Johnson and Johnson Resuming U.S. Tests of COVID-19 Vaccines

The Associated Press

Two drugmakers announced Friday the resumption of U.S. testing of their COVID-19 vaccine candidates.

Testing of AstraZeneca’s vaccine candidate had been halted since early September, while Johnson & Johnson’s vaccine study was paused at the beginning of last week. Each company had a study volunteer develop a serious health issue, requiring a review of safety data.

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White House to Block FDA Vaccine Guidelines That Would’ve Delayed Approval Past Election

Michigan Star Staff

The White House blocked new vaccine guidelines proposed by health officials within the Trump administration, which likely would have pushed the approval of a coronavirus vaccine past the election.

The Food and Drug Administration (FDA), which is in charge of approving vaccines, proposed the guidance on Sept. 21, according to The New York Times. White House chief of staff Mark Meadows raised concerns with one provision of the guidelines which said vaccine trial subjects should be examined for two months following their final dose, a senior administration official told the Times.

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NIH: Halted Vaccine Study Shows ‘No Compromises’ on Safety

The Associated Press

The suspension of a huge COVID-19 vaccine study over an illness in a single participant shows there will be “no compromises” on safety in the race to develop the shot, the chief of the National Institutes of Health told Congress on Wednesday.
AstraZeneca has put on hold studies of its vaccine candidate in the U.S. and other countries while it investigates whether a British volunteer’s illness is a side effect or a coincidence.

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Commentary: Lowering the Cost of Prescription Medicines for Seniors Is Not Impossible

Michigan Star Staff

Earlier this year James Payne, a 73-year-old retired attorney in Utah, was so fed up with the high cost of a blood thinner medication he takes, he researched prices in Canada, where he found it was cheaper.

“Under Medicare, I am now paying $225 for a three-month supply,” Payne explained. “That’s $25 more than I was paying last year. Under my employer’s insurance I was only paying $20.” Payne says he is not sure why the costs are so much higher and continue to climb under Medicare, but he thinks there must be ways to make life-saving medications more affordable.

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President Trump Announces Plasma Treatment Authorized for COVID-19

The Associated Press

President Donald Trump announced Sunday the emergency authorization of convalescent plasma for COVID-19 patients, in a move he called “a breakthrough,” one of his top health officials called “promising,” and other health experts said needs more study before it’s celebrated.

The announcement comes after days of White House officials suggesting there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease that has upended Trump’s reelection chances.

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FDA Revokes Emergency Use of Malaria Drugs to Treat Coronavirus, Cites ‘Potential Risks’

The Associated Press

U.S. regulators on Monday revoked emergency authorization for malaria drugs promoted by President Donald Trump for treating COVID-19 amid growing evidence they don’t work and could cause deadly side effects.

The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the FDA said the drugs’ unproven benefits “do not outweigh the known and potential risks.”

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Commentary: Progressive Woke Orthodoxy Obscures the Truth About the Virus

Michigan Star Staff

Americans are acquainted with predictable but ultimately failed progressive efforts to suppress free expression by preemptive invective and politically correct finger-pointing.

To believe that U.S. Supreme Court Justice Brett Kavanaugh’s accusers revealed too many contradictions, too many lacunae, too many episodes of timely amnesia, and too many unsubstantiated accusations in their testimonies was chauvinistically to attack/smear/silence all women’s voices – at least until the same sort of memory-repressed accusations focused on handsy Joe Biden.

To express skepticism that current global temperatures are uniformly rising almost entirely due to human carbon emissions, that this state of affairs poses catastrophic dangers that may end civilization as we know it, and that this emergency can only be addressed by the radical restructuring of global economies is to be rendered a denialist, a crank, a fool.

But these parameters of censorship have a logic and predictability, given their race/class/gender/environmental orthodoxy.

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FDA Issues Emergency Authorization Of Anti-Malaria Drugs As Doctors Herald Results For Coronavirus Patients

Michigan Star Staff

The United States Food and Drug Administration issued an emergency use authorization for donated anti-malaria drugs hydroxychloroquine sulfate and chloroquine phosphate as doctors say the drugs are showing positive results for coronavirus patients.

The FDA issued the authorization to allow doctors to distribute and prescribe the anti-malaria drugs to hospitalized teen and adult patients who have coronavirus, the Department of Health and Human Services said in a press release. Doctors may distribute and prescribe the drugs “as appropriate, when a clinical trial is not available or feasible.”

The emergency authorization was issued to the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority, which is working with the National Institute of Health to plan clinical trials of the drugs.

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Mayo Clinic Says It Can Now Perform Up to 4,000 COVID-19 Tests Daily

Anthony Gockowski

Mayo Clinic announced last week that it can now test up to 4,000 clinical samples for SARS-CoV-2, the virus that causes COVID-19, on a daily basis.

Mayo officials said they now have the capacity to process COVID-19 test samples at all Mayo Clinic sites and have started processing test samples from their clients across the state, including eight major health systems.

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FDA Authorizes New 45 Minute Coronavirus Test for Release Next Week

Chris Butler

A California-based molecular diagnostics company announced Saturday they will ship a point-of-care test next week that they say can detect SARS-CoV-2, the virus causing COVID-19 in 45 minutes.

Officials at the U.S. Food and Drug Administration gave that company, Cepheid, Emergency Use Authorization to do so, company officials said in a press release.

Called the Xpert Xpress SARS-CoV-2, the test is designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, with a detection time of less than one hour.

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President Trump Says FDA Has Approved Testing of Anti-Malaria Drug Chloroquine for Treating Coronavirus

Anthony Gockowski

President Donald Trump announced during a Thursday press briefing that the anti-malarial drug chloroquine was approved by the Food and Drug Administration as a possible treatment for the coronavirus.

The announcement comes the day after Breitbart News reported that the medical establishment has known about chloroquine’s effectiveness in treating the virus since at least the 2005 SARS coronavirus outbreak.

“Clinical trials are already underway for many new therapies and we’re working on scaling these to allow many more Americans to access different drugs that have shown really good promise,” President Trump said.

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