A majority of children on Dupixent (up to 68% on a higher dose) achieved histological disease remission at week 16
First and only Phase 3 trial to show positive results in this patient population; there are currently no approved treatments specifically indicated for children under 12 years of age with EoE
https://finance.yahoo.com/news/dupixent-dupilumab-breaking-phase-3-045900407.html
DOI: 10.1126/sciimmunol.add5446
Attempts by Oxford University researchers and AstraZeneca Plc to create a nasal-spray version of their jointly developed COVID-19 shot suffered a setback on Tuesday as initial testing on humans did not yield the desired protection.
An antibody response in the respiratory mucous membranes was seen in only a minority of participants in the trial, which was in the first of usually three phases of clinical testing, the University of Oxford said in a statement on Tuesday.
Also, the immune response measured in the blood was weaker than that from a shot-in-the-arm vaccination.
Researchers across the world have placed high hopes on nasal spray vaccines against the coronavirus because the method is believed to potentially prevent infection and not just disease as it may prompt an immune response directly in the airways, where the virus enters the body.
In addition, the method would be less painful and easier to handle than injections.
Regulators in India and China have already cleared products that are administered through the airways.
India's health minister last month approved Bharat Biotech's COVID-19 nasal spray vaccine while China's CanSino Biologics Inc last month won emergency approval by the country's drug regulator for an inhaled version of its COVID-19 vaccine.
CanSino has said studies indicated that its vaccine, delivered via a nebuliser device, can induce strong immunity to effectively contain infection, while Bharat's trial results have not yet been published.
The British trial enrolled 30 previously unvaccinated participants as well as 12 volunteers, who had previously received a standard two-dose vaccine course by injection.
"The nasal spray did not perform as well in this study as we had hoped," said Sandy Douglas, chief investigator of the trial at Oxford University's Jenner Institute.
"We believe that delivery of vaccines to the nose and lungs remains a promising approach, but this study suggests there are likely to be challenges in making nasal sprays a reliable option," she added.
No serious adverse events or safety concerns were reported during the trial, which was funded by AstraZeneca, according to the statement.
Conformity of thought is now required whether it is online, on college campuses, or, if you are in California, in a physician-patient relationship.
PayPal recently introduced a $2,500 fine for anyone involved in “the sending, posting, or publication of any messages, content, or materials” that — in “PayPal’s sole discretion” — “promote misinformation.”
After a firestorm of criticism, PayPal withdrew the policy, claiming the whole thing was a misunderstanding and was not official policy— hardly a convincing explanation from a site with a history of banning those it considers politically incorrect.
But California physicians have had no such relief.
Gov. Gavin Newsom recently signed California Assembly Bill 2098, making it the first state to attempt to censor what physicians can say about COVID-19 to their patients. This is a dangerous, and likely unconstitutional, effort that other states must resist.
The statute instructs that, “It shall constitute unprofessional conduct for a physician and surgeon to disseminate misinformation or disinformation related to COVID-19, including false or misleading information regarding the nature and risks of the virus, its prevention and treatment; and the development, safety, and effectiveness of COVID-19 vaccines.”
California law requires the Medical Board of California to take action — up to and including license revocation — against any licensed physician charged with unprofessional conduct. But under the First Amendment, content-based speech regulation by government entities is presumptively unconstitutional and may be justified only if the government proves that it is narrowly tailored to serve compelling state interests.
A 2018 Supreme Court case, National Institute of Family and Life Advocates v. Becerra, held that professional speech — speech by licensed practitioners based on their expert knowledge and judgment — is protected by the First Amendment.
The court though did suggest that regulations of professional conduct that incidentally burden speech might be allowed. Speech that is part of the practice of medicine has historically been subject to reasonable licensing and regulation by states.
It is not clear whether providing information to a patient — such as whether mask-wearing works and is necessary or discussing the safety of in-person learning — is closely tied enough to medical practice and procedures to pass constitutional muster. This will undoubtedly be decided in future litigation.
But the statute clearly has constitutional problems in defining COVID “misinformation.”
The law’s definition is “false information that is contradicted by contemporary scientific consensus contrary to the standard of care.” This is ridiculously and likely unconstitutionally vague.
As the Supreme Court noted, “Professionals might have a host of good-faith disagreements, both with each other and with the government, on many topics in their respective fields.”
Physicians who inform their young, healthy patients that the virus poses a minuscule risk of serious illness and death to them is providing truthful information, even though other practitioners or the government might claim that doing so is contrary to the standard of care.
Similarly, telling a parent as part of an informed-consent discussion that vaccines currently have minimal effectiveness in limiting COVID transmission and small benefits for healthy children, but that they also have incompletely characterized side-effects, is not false information, even though the standard recommendation is that everyone should be vaccinated.
The statute does not specify who is the arbiter of “contemporary scientific consensus” on COVID.
The CDC, which has routinely changed its guidance over the course of the pandemic?
Dr. Anthony Fauci, who repeatedly flip-flopped on the effectiveness of masks?
It is unfair, and likely violates due process, to ask practitioners to risk their licenses without telling them who or what will judge their speech.
Ultimately, California’s law will harm patients, depriving them of information and undermining trust in their physicians who will be scared to speak their minds.
California’s new statute is the latest iteration of efforts to enforce conformity of thought and mirrors efforts by government bureaucrats throughout the pandemic to pressure social media companies to censor those who didn’t follow the official line.
I, for one, think my physician is a better judge of medical information than Silicon Valley elites and liberal legislators.
Joel Zinberg, MD, is a senior fellow at the Competitive Enterprise Institute and director of public health and wellness at the Paragon Health Institute.
https://nypost.com/2022/10/10/california-makes-it-illegal-for-doctors-to-disagree-with-politicians/
Shares of Rigel Pharmaceuticals Inc. were lower in Monday's late-trading session, after the company said it received "guidance from the U.S. Food and Drug Administration's review of the company's re-analysis of data from the FORWARD Phase 3 trial of fostamatinib for the treatment of patients with warm autoimmune hemolytic anemia."
Based on the guidance, the company said it doesn't expect to file a supplemental new drug application for the indication at this time.
The company also said it was cutting its workforce by 16%. The move will see 30 positions be eliminated, primarily in development and administration, Rigel said.
At 4:53 p.m. ET, the company's shares were trading 16.75% lower at $94 cents a share. The stock finished the day's regular session flat at $1.14 a share.
"Rigel will continue to explore its options for the wAIHA program in relation to its complete portfolio of development opportunities," the company said.
A small-business advocacy group has filed a new lawsuit seeking to block the Biden administration’s efforts to forgive student loan debt for tens of millions of Americans — the latest legal challenge to the program.
The suit, filed Monday by the Job Creators Network Foundation, argues the Biden administration violated federal procedures by failing to seek public input on the program. It’s one of a handful of lawsuits that have been filed by conservative business groups, attorneys and Republican lawmakers in recent weeks as the Biden administration tries to push forward with its plan to cancel billions in debt before November’s midterm elections.
Elaine Parker, president of Job Creators Network Foundation, slammed the program as executive overreach and complained that it does nothing to address the root cause of rising debt: the “outrageous increase in college tuition that outpaces inflation every single year.”
“This bailout is going to affect everyone in this country because of the mass size of the program,” she said. “And everyone should have the opportunity to provide their views to the government.” She added: “These universities need to be held accountable for this student debt crisis.”
The Job Creators Network Foundation has previously turned to the courts to try to to block the Biden administration’s COVID-19 vaccine mandate on businesses. It also sued Major League Baseball in 2021 for moving the All-Star game out of Atlanta over objections to changes to Georgia’s voting laws. That lawsuit, which cited losses to local businesses, was later dropped.
The new lawsuit is one of a growing number of legal challenges trying to halt the proposal laid out by President Joe Biden in late August to cancel up to $20,000 in debt for certain borrowers.
Six Republican-led states filed suit late last month, accusing the Biden administration of overstepping its executive powers, as did the Pacific Legal Foundation, a Sacramento, California, legal advocacy group. Their lawsuit, filed in federal court in Indiana, calls the plan an illegal overreach that would increase state tax burdens for some Americans who get their debt forgiven.
Meanwhile, a federal judge in Wisconsin last week dismissed a lawsuit from a local taxpayers group, the Brown County Taxpayers Association, that sought to block the program, ruling that the group didn’t have standing to bring the lawsuit. The group had argued that Biden’s order unlawfully circumvented Congress’ power over spending and said the plan was discriminatory because it sought to give particular help to borrowers of color.
The latest lawsuit, filed in U.S. District Court for the Northern District of Texas against the U.S. Education Department and its secretary, Miguel Cardona, takes issue with how the plan was developed. It alleges the Biden administration violated the Administrative Procedure Act’s notice-and-comment procedures. It also challenges the administration’s legal justification for the program.
The suit includes two plaintiffs: one who does not qualify for debt forgiveness because the plan excludes commercially held loans that are not in default, and one who did not receive a Pell grant and is therefore entitled to less debt forgiveness under the plan.
“Behind closed doors, the Department promulgated a new Debt Forgiveness Program that will affect tens of millions of Americans and cost hundreds of billions of dollars,” the lawsuit reads. “Instead of providing notice and seeking comment from the public, the Department hammered out the critical details of the Program in secret and with an eye toward securing debt forgiveness in time for the November election.”
It also alleges the department “made numerous arbitrary decisions about the Program, including which individuals will receive debt forgiveness, how much of their debt will be forgiven, and which types of debt will qualify for the Program.”
“The result of this arbitrariness is predictable: some will benefit handsomely, some will be shortchanged, and others will be left out entirely,” it reads.
The case was assigned to U.S. District Judge Reed O’Connor, who most notably ruled in 2018 that the Affordable Care Act was unconstitutional. The Supreme Court reversed that decision last year. O’Connor, an appointee of former President George W. Bush, also has ruled against other policies pursued by Democratic administrations. Last month, he ruled that an ACA provision that required coverage of an HIV prevention drug violates a Texas employer’s religious beliefs.
Civil lawsuits filed in the federal court in Fort Worth have a 90% chance of going either to O’Connor or Judge Mark Pittman, an appointee of former President Donald Trump, according to a 2020 order of the court.
White House spokesman Abdullah Hasan responded with a statement defending the loan forgiveness program.
“While opponents of our plan are siding with special interests and trying every which way to keep millions of middle-class Americans in debt, the President and his Administration are fighting to lawfully give middle-class families some breathing room as they recover from the pandemic and prepare to resume loan payments in January,” he said in a statement.
The Biden debt forgiveness program will cancel $10,000 in student loan debt for individuals making less than $125,000 a year or households making less than $250,000. Pell grant recipients, who typically demonstrate more financial need, will be eligible for an additional $10,000.
The Biden administration used an act passed after the Sept. 11, 2001, terrorist attacks as legal justification for the program. The law gives the administration “sweeping authority” to reduce or eliminate student debt during times of national emergency, the Justice Department said in an August legal opinion. The administration cited the COVID-19 pandemic as its emergency.
The Congressional Budget Office estimates the program will cost taxpayers $400 billion over the next three decades.
Two Republican state attorneys general have sued former Biden COVID czar Andy Slavitt and other administration officials as part of an ongoing lawsuit over collusion between the feds and big tech in order to suppress COVID-related free speech.
The complaint, requesting the deposition of "key defendants," was filed by Republican Attorneys General Eric Schmitt of Missouri and Jeff Landry of Louisiana, and cites a third-party subpoena of Twitter, Meta and YouTube, which identified a variety of White House and administration officials, the Daily Caller reports.
Journalist Alex Berenson - who was banned from Twitter on April 21, 2001 and sued his way back onto the platform - called out Slavitt in an August Substack article.
Andrew Slavitt, senior advisor to President Biden’s Covid response team, complained specifically about me, according to a Twitter employee in another Slack conversation discussing the White House meeting.
“They really wanted to know about Alex Berenson,” the employee wrote. “Andy Slavitt suggested they had seen data viz [visualization] that had showed he was the epicenter of disinfo that radiated outwards to the persuadable public.”
According to an interview he gave to the Washington Post in June 2021, Slavitt worked directly with the most powerful officials in the federal government, including Ron Klain, President Biden’s chief of staff, and Biden himself. -Unreported Truths
Slavitt, meanwhile, has lawyered up.
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