The U.S. Food and Drug Administration on Friday approved a new drug to treat Alzheimer’s disease, with testing reportedly showing considerable success in helping patients with the debilitating condition.
The FDA said in a press release that it had approved the drug Leqembi for Alzheimer’s patients. The drug is “the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease,” the agency said.
The FDA’s Twitter habits are getting scrutiny in court and from medical professionals as the feds seesaw between walking back their once-confident COVID-19 assertions and making sweeping new claims without providing evidence.
Having long ago conceded that COVID vaccines can’t stop viral transmission and that assertions to the contrary by President Biden among others were based on “hope” rather than science, the feds are now downplaying the influence of their social media to escape liability for allegedly violating statutory limits by interfering in medical judgments.
Puberty blockers are widely touted by doctors and transgender activists as a safe and fully reversible way to pause puberty for children with gender identity issues, but a growing body of evidence is challenging those claims, according to The New York Times.
The drug prevents the surge in bone density that would normally occur during puberty, and patients can see lifelong bone issues that are never resolved, according to the Monday NYT article. Medical professionals are also challenging claims that the drug is reversible, arguing instead that blocking puberty permanently cements a child’s transgender identity and puts them on a path to lifelong biomedical intervention.
Pfizer Inc. and BioNTech announced Wednesday the Biden Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for their “bivalent” mRNA COVID-19 booster shot for children aged 5-11 years without having completed clinical trials.
“As families across the country take part in fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the Omicron BA.4/BA.5 subvariants, which continue to account for more than 80% of cases in the U.S.,” said Pfizer CEO Albert Bourla. “Anticipating this need, we manufactured millions of booster doses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID-19 vaccinations.”
Senator Rand Paul (R-KY) once again battled with White House chief medical advisor Dr. Anthony Fauci Wednesday about whether children with natural immunity from a prior COVID infection should be injected with the mRNA shots the government has referred to as “vaccines.”
“Dr. Fauci continues to lie, cover-up, and deny the science to promote himself,” tweeted Paul about his tense exchange with Fauci during a Senate committee hearing whose central focus was the federal response to monkeypox.
The U.S. Food and Drug Administration (FDA) on Wednesday approved a gene therapy for a rare blood disease which is set to reach the market at a record $2.8 million for a single dose, according to a press release by the therapy’s creator, Bluebird Bio.
Beta-thalassemia is an inherited blood disorder that causes a patient’s blood to fail to circulate oxygen through the body, according to the FDA press release concerning the approval. Bluebird’s new therapy, Zynteglo, infuses patients with cells that have a working copy of the gene responsible for the disorder, allowing the patient to produce blood that functions properly, according to a Bluebird press release.
As negotiations on their tax and spending bill continue, Senate Democrats are working on a legislative proposal to have the government fix the prices of Medicare prescription medications. Though the details of the 190-page amendment differ in certain respects from earlier versions, the indisputable result would be the same: Reduced patient access to prescription drugs.
Like most giant regulatory schemes, the draft proposal is characteristically complex with numerous provisions, including detailed data collection, new mandates, tax penalties on drug manufacturers, free vaccines, and a cap on out-of-pocket costs. But the heart of the bill is the creation of a Drug Price Negotiation Program administered by the Secretary of the U.S. Department of Health and Human Services (HHS).
A federal appeals court on Friday granted a request for a temporary stay to vape manufacturer Juul Labs Inc. in its fight against the U.S. Food and Drug Administration’s ban of its e-cigarettes from being sold in the U.S.
The FDA issued marketing denial orders (MDOs) Thursday and said JUUL’s current inventory being sold in the U.S. “must be removed, or risk enforcement action.”
The Food and Drug Administration (FDA) quickly authorized the Moderna and Pfizer-BioNTech COVID vaccine shots for infants and young children Friday, paving the way for the Centers for Disease Control and Prevention (CDC) advisory committee to vote on authorization over the weekend to allow the youngest children to get the shots as early as next week.
Per the press announcement by the FDA, the Emergency Use Authorization (EUA) for the Moderna COVID vaccine for older children and adults has been “amended” to “include use of the vaccine in individuals 6 months through 17 years of age,” while the EUA for the Pfizer COVID shot will now include use of the vaccine for babies as young as “6 months through 4 years of age.”
A group of Republican lawmakers in the U.S. Senate and House are demanding answers from the Food and Drug Administration (FDA) and its vaccine panel regarding the Emergency Use Authorization (EUA) application for COVID vaccines in babies and young children under five years of age.
Though young children without other significant medical issues bear the least risk of serious illness from catching the COVID infection, White House COVID-19 Response Coordinator Dr. Ashish Jha is already planning for the distribution of COVID vaccines for babies and toddlers under five years of age as early as June 21 if the FDA and CDC approve.
An official with the Food and Drug Administration (FDA) claims that the reason the agency didn’t find a shocking whistleblower’s report on the baby formula shortage because the report was lost in the mailroom for at least four months.
The New York Post reports that the 34-page document had been sent to the FDA back in October, claiming that an Abbott Nutrition plant in Sturgis, Michigan was experiencing a shortage in product primarily due to increasingly unsanitary conditions. The FDA’s Frank Yiannas, Deputy Commissioner for Food Policy and Response, admits he didn’t actually see the report until February.
The Food and Drug Administration (FDA) was aware early on that the COVID vaccines could spur viral reactivation of diseases like the varicella-zoster virus (shingles) in some people, but chose not to disclose it, according to renowned vaccinologist and physician Dr. Robert Malone.
“They knew about the viral reactivation,” Malone declared during a recent panel discussion hosted by Del Bigtree with fellow Global COVID Summit physicians Dr. Ryan Cole, and Dr. Richard Urso.
At the outset of his presidency, Joe Biden promised competence by a bigger, better government. A few days ago, one of his loyal allies exposed a gross incompetence by federal officials on Biden’s watch that defied that promise and inflamed a baby formula shortage now panicking parents nationwide.
Rep. Rose DeLauro, D-Conn., a reliable liberal ally, unveiled documents showing the Biden Food and Drug Administration was alerted by a whistleblower last fall about potential contamination issues at the Abbott Nutrition baby formula factory in Michigan and failed for months to act aggressively.
The number of commercial and backyard flocks with confirmed avian flu increased by 36% in the past week, according to data on the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) website.
Three of the 57 new cases reported were in Missouri, bringing the state total to nine cases of Highly Pathogenic Avian Flu Influenza (HPAI) in seven counties—Bates, Dade, Gentry, Jasper, Lawrence, Ralls and Stoddard. Approximately 421,000 birds were in those flocks.
The omicron variant may be nearing its peak in some states, but across the country it’s produced a dizzying array of conflicting signals on whether the nation should remain under a COVID national emergency or move on to an endemic “new normal.”
Comedian Bill Maher’s “I don’t want to live in your mask-paranoid world anymore” monologue went viral last week, just days after the Atlantic, the standard-bearer journal for the liberal intelligentsia, ran a story headlined: “COVID Parenting Has Passed the Point of Absurdity.” Accompanying the article was a black-and-white photo of a woman frozen in a more desperate and primal state of panic than the subject of Edvard Munch’s “The Scream.”
Omicron, for most people without co-morbidities, produces much milder symptoms than do the coronavirus’s previous variants, but it’s far more infectious, racing through schools, shutting down classrooms and forcing parents to consult their district’s ever-shifting COVID “decision trees” on a seemingly daily basis.
The U.S. Food and Drug Administration (FDA) Monday unexpectedly pulled its Emergency Use Authorization (EUA) for monoclonal antibody treatments for COVID-19, dealing a blow to states like Florida which have been using the treatment effectively for months.
“Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” Gov. Ron DeSantis (R) said in response to the FDA’s decree. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives. There are real-world implications to Biden’s medical authoritarianism – Americans’ access to treatments is now subject to the whims of a failing president.”
New York-based Pfizer has sold and shipped hundreds of millions of doses of its Food and Drug Administration (FDA) approved COVID-19 vaccine Comirnaty to the European Union (EU) despite saying last week that it is not being shipped in the United States.
“Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021,” Pfizer said in an April press release. “This announcement is a result of the European Commission’s (EC) decision to exercise its option to purchase an additional 100 million doses under its expanded Advanced Purchase Agreement signed on February 17, 2021. This brings the total number of doses to be delivered to the EU to 600 million.”
Through Ohio attorneys representing Miami University in a lawsuit against the school over its mandatory COVID-19 vaccine policy, The Ohio Star confirmed that at least none batches of Pfizer’s Emergency Use Authorization (EUA) vaccine were deemed Biologics License Application (BLA) compliant.
BLA compliance is typically reserved for Food and Drug Administration (FDA) approved drugs. That is the licensing procedure for drugs seeking to become FDA approved.
The FDA on Wednesday authorized the first COVID-19 antiviral pill in the U.S.
The Pfizer pill, Paxlovid, will be prescribed for use in adults and children 12 and older who have mild to moderate virus symptom and at risk for severe disease or hospitalization, according to a Food and Drug Administration statement obtained by NBC News.
The majority opinion released on Friday by the 6th Circuit Court of Appeals, which restored the Biden administration’s Occupational Safety and Health Administration (OSHA) Emergency Temporary Standard (ETS) requiring employers with more than 100 employees to mandate that all employees take a COVID-19 vaccinefalsely asserts that Pfizer’s Food and Drug Administration (FDA) fully approved vaccine is currently available and in use among the general public.”
“At the same time, the options available to combat COVID-19 changed significantly: the FDA granted approval to one vaccine on August 23, 2021, and testing became more readily available,” the majority opinion asserts on page 24 of the ruling.
The majority opinion was written by Obama-appointed Judge Jane Branstretter Stranch of the United States Court of Appeals for the Sixth Circuit.
On Monday, the Food and Drug Administration (FDA) requested that the courts allow the agency to wait until the year 2076 to release all of the relevant documents regarding the approval of the vaccine developed by Pfizer and BioNTech, as reported by the Daily Caller.
The FDA made its request after a lawsuit was filed against the agency by the group Public Health Medical Professionals for Transparency (PHMPT). The PHMPT had previously made a Freedom of Information Act (FOIA) request on September 9th asking for the release of the vaccine approval documents; after the FDA denied the request, the group filed its lawsuit on September 16th.
The FDA concluded that there were roughly 329,000 pages in total that would qualify under this FOIA request. In its appeal to the courts, the agency said that, at most, employees would be able to “process and produce the non-exempt portions of responsive records at a rate of 500 pages per month.” Under this process, the FDA said that it would hand over prioritized documents to the plaintiff, and release non-exempt documents on a “rolling basis.”
The Food and Drug Administration (FDA) approved Moderna and Pfizer’s COVID-19 vaccines for booster shot use for adults in the U.S., the agency announced Friday,
The announcement was made just two months after the FDA first rejected the White House’s plan to administer booster shots to all adults the week of Sept. 20. FDA Acting Commissioner Janet Woodcock approved the booster without holding the usual public meeting to review the data, and the Centers for Disease Control and Prevention (CDC) will meet Friday afternoon to discuss the authorization, according to the FDA press release.
“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19,” Woodcock said in the press release.
President Joe Biden on Friday announced the nomination of Robert Califf to head up the Food and Drug Administration again, urging the Senate to quickly confirm him a second time.
Califf, who served in the same role near the end of then-President Barack Obama’s second term, is “one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden said in a statement announcing the pick.
“I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making,” the president added, pointing out that Califf enjoyed “strong bipartisan support in the Senate in 2016.”
On August 24, Secretary of Defense Lloyd Austin issued a memo to senior Pentagon leadership announcing that he was implementing a mandatory COVID-19 vaccination policy for all military service members. The day before, the FDA had issued full authorization to Pfizer for their Comirnaty COVID-19 vaccine product (the nomenclature of which is meant to be a mashup of the words “COVID”, “mRNA”, and “community”) . At first glance it would seem that the mandatory vaccination policy, while scientifically unsound and strategically foolish, was at least a policy being implemented according to both the letter of the directive and in accordance with the law. But a further examination of the facts and the manner in which this order is being implemented makes clear that the military’s implementation of this order is illegal and highly unethical.
In the memo, Secretary Austin issued a directive and a promise, that “Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance.” The problem with this is that the Comirnaty vaccine product that was approved by the FDA is not available anywhere in the Military Health System. It is not even in production, according to the military’s TRICARE healthcare providers. If a soldier goes to a military hospital or a private provider to receive an approved Pfizer COVID vaccine, he will be administered the unapproved Pfizer-BioNTech vaccine which is a vaccine that is not approved but has been administered under an Emergency Use Authorization (EUA). We are told that this is but a brand name difference, that the formulation is the same, and they can be used interchangeably. But as the FDA was approving the Comirnaty product, they were renewing the authorization for the Pfizer-BioNTech product. If it’s just a matter of brand name, why issue an approval for one brand name and an EUA renewal for the other? This is because they are not actually the same.
Competition tends to bring about a better product or service, at a lower price, than does monopoly. This is a basic premise held by virtually all economists, disputed by pretty much no one in the profession. The entire antitrust edifice of the American system is built upon this foundational aspect of the dismal science.
And yet when push comes to shove, our society jettisons this insight, at least when it comes to assuring the quality of our food and drugs.
The Food and Drug Administration is a monopoly agency entrusted with this task. Its word is final concerning such matters. No competition is allowed. If a private agency set itself up as an alternative, it would first be subjected to raucous laughter, and then its creators jailed.
The FDA is a licensing agency. If it does not approve of a food or drug, it is illegal to offer it for sale. What is the non-monopolistic alternative to this sad state of affairs? This is called certification. How, pray tell, does this work? It is simple. Different firms set themselves up as evaluators of the quality of food and drugs, and each of them subjects these products to their examinations. They certify some as approved, and list others as not approved.
The CDC adopted a “double-standard exclusively for COVID-19 data collection” that inflated cases and deaths starting early in the pandemic, violating multiple federal laws and distorting mitigation policies, Oregon lawmakers told the feds’ top lawyer in the state.
Advised by “a large team of world-renowned doctors, epidemiologists, virologists, and attorneys,” state Senators Kim Thatcher and Dennis Linthicum petitioned U.S. Attorney Scott Asphaug to approve a grand jury investigation into how the pandemic is being measured.
In sharp contrast to every other top-ten cause of death, Alzheimer’s disease has long lacked affordable and accessible ways to diagnose it. While doctors have been able to tell patients with almost 100% certainty whether they have diabetes, heart disease or cancer, until recently, Alzheimer’s was a diagnosis of exclusion.
Doctors could look for signs of Alzheimer’s. They could test memory and other cognitive skills, judge a patient’s ability to perform routine tasks, and ask their friends and family about any behavior changes. MRIs could determine brain volume, which diminishes as Alzheimer’s progresses. But blood and other diagnostic tests were used only to rule out other possible causes of their symptoms, such as B12 deficiency or thyroid disorders.
The Food and Drug Administration assured the Daily Caller News Foundation Friday that it has not entered into any contracts “for the purchase of human fetal tissue” since 2018.
The agency’s response follows the release of documentation obtained by Judicial Watch showing that the FDA procured fetal organs, tissue, and heads for research that involved “humanized mice.” Previous documents uncovered by Judicial Watch found that the FDA requested “fresh and never frozen” fetal organs.
“I’ve been doing this for 23 years. These documents we’ve gotten from the FDA and our other lawsuit…they are the worst things I’ve ever seen,” Judicial Watch President Tom Fitton told the Daily Caller News Foundation Friday. “The most troubling documents I’ve ever seen.”
The Centers for Disease Control and Prevention’s guidance ultimately hindered the U.S. response to the pandemic, former FDA Commissioner Scott Gottlieb wrote in his upcoming book “Uncontrolled Spread,” set to be released Sept. 21.
Gottlieb said in the book that U.S. intelligence agencies need to play a more active role in preparing for a pandemic, as opposed to leaving plans solely to health agencies like the CDC.
“We need to have human assets in the medical community so we understand when an outbreak emerges,” Gottlieb said, Axios reported. “We need to have the capability of monitoring typical streams of intelligence, like signals intelligence and maybe even satellite intelligence, looking for things that could be trip wires for an outbreak of disease.”
Top U.S. health officials told the White House pandemic coordinator on Thursday to scale back the Biden administration’s plan to administer the coronavirus booster shots to individuals in September, The New York Times reported.
Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration (FDA), and Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention (CDC), told White House Coronavirus Response Coordinator Jeffrey D. Zients that they need more time to collect and analyze the necessary data relating to the booster shots, The New York Times reported.
The doctors told Zients that their agencies might be able to determine whether to recommend boosters for recipients of the Pfizer-BioNTech vaccine in the coming weeks, according to the Times.
The two doctors presented their argument to Zients at a meeting on Thursday. It is unclear how Zients responded to the news.
Alan Dershowitz says calls for the impeachment of Joe Biden are “wrong.” He claims in his most recent op-ed at the D.C. establishment’s favorite Republican rag, The Hill: “Whatever one may think of what Biden did or failed to do, it does not constitute an impeachable offense under the text of the Constitution.” With all due respect, Dershowitz is full of crap.
“The Framers,” Dershowitz writes, “insisted that a president could not be impeached unless he committed criminal-type conduct akin to treason and bribery.” If this is true, then why did President Thomas Jefferson call for the impeachment of a federal district judge on the grounds that he was “a man of loose morals and intemperate habits?” Jefferson was a prominent founder, who greatly influenced the framers of the Constitution.
President Joe Biden encouraged private sector companies Monday to “step up” vaccine requirements for employees following the Food and Drug Administration’s approval of the Pfizer COVID-19 vaccine.
“If you’re a business leader, a non-profit leader, a state or local leader, who has been waiting for full FDA approval to require vaccinations, I call on you now to do that. Require it,” Biden said. “Do what I did last month. Require your employees to get vaccinated or face strict requirements.”
The lawyer representing students challenging Indiana University’s COVID vaccine mandate has been “retained by students in other states to bring similar claims,” he said in an interview Tuesday.
Veteran litigator James Bopp told the John Solomon Reports podcast that he expects to file suit in another “four or five states in the next couple of weeks.”
United Airlines announced Friday that it will require all employees to be vaccinated against COVID-19 starting this fall, making it the first major airline to do so.
“We know some of you will disagree with this decision to require the vaccine for all United employees,” United CEO Scott Kirby and President Brett Hart announced in a memo. “But, we have no greater responsibility to you and your colleagues than to ensure your safety when you’re at work, and the facts are crystal clear: everyone is safer when everyone is vaccinated.”
The order requiring proof of vaccination will go into effect five weeks after the Federal Drug Administration officially gives full approval of the COVID-19 vaccines, or by Oct. 25, whichever comes first, The Hill newspaper reports. The FDA is expects to start giving full approval as early as next month.
The cities of Phoenix, Tucson, Peoria, Tempe, and Flagstaff have all announced reinstatement of their mask mandates following the updated CDC guidance. The mayors of these cities directed their officials to mandate masks in city facilities regardless of vaccination status. Tempe and Tucson’s mandate went into effect on Wednesday, Peoria’s mandate on Thursday, and Flagstaff’s mandate on Friday. Phoenix’s mandate will go into effect on Monday.
As The Arizona Sun Times reported, the CDC recommended on Tuesday that everyone – even fully-vaccinated individuals – wear masks inside public spaces where high transmission rates exist. The CDC claimed that this reversed guidance was influenced by the surge of Delta variant cases. The CDC mentioned that certain data necessitated this change, but hasn’t published it.
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.
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.
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.
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.