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Tuesday, April 2, 2024

Vanda OKd on Acute Treatment of Bipolar I Disorder

 Fanapt® Treatment is Now Available to Adult Patients for the Acute Treatment of Manic or Mixed Episodes Associated with Bipolar I Disorder

Approval Represents Significant Novel Indication for Vanda's Fanapt® Franchise

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt® (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Fanapt® is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009.

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-fanapt-iloperidone-receives-us-fda-approval-for-the-acute-treatment-of-bipolar-i-disorder-302106405.html

Adaptive Biotechnologies Strategic Review Update, Prelims

 After evaluating a number of potential opportunities as part of the strategic review, Adaptive’s management team and board of directors concluded that the current best outcome to maximize shareholder value is to operate the MRD and Immune Medicine businesses internally within Adaptive while increasing their independence from one another by restructuring each business with dedicated resources and separate segment reporting. Importantly, under this structure, Adaptive preserves its strong capital position which will bridge the MRD business to profitability and support targeted investments in Immune Medicine.

Management will provide further details on the process and outcome of the strategic review during the conference call this afternoon.

First Quarter 2023 Preliminary, Unaudited Revenue Results

  • Total revenue of approximately $41 to $43 million for the first quarter of 2024, an increase of approximately 12% compared to the first quarter of 2023.
  • MRD revenue of approximately $31 to $32 million for the first quarter of 2024, an increase of approximately 47% compared to the first quarter of 2023.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its business updates after market close on Tuesday, April 2, 2024 at 1:30 PM Pacific Time / 4:30 PM Eastern Time. The conference call can be accessed at http://investors.adaptivebiotech.com. The webcast will be archived and available for replay at least 90 days after the event.

https://www.globenewswire.com/news-release/2024/04/02/2856460/0/en/Adaptive-Biotechnologies-Provides-Strategic-Review-Update-and-Announces-Preliminary-First-Quarter-2024-Revenue.html

Tennessee Lawmakers Pass Bill Targeting mRNA Vaccines In Food

 Following concerns over research to embed vaccines in produce, the Tennessee Senate has passed a bill which would require any food containing vaccines or vaccine materials to be labeled as pharmaceutical drugs.

The bill, HB 1894, was passed by the Senate in a 23-6 vote on March 28 after the state House passed it 73-22 on March 4. It awaits the governor's signature.

The bill comes in response to a University of California-Riverside research project looking into whether mRNA which targets pathogens could be implanted into edible plants, which would then be consumed. The research was funded by a $500,000 grant from the National Science Foundation.

"You would have to get a prescription for that to make sure that we know how much of the lettuce you have to eat based off of your body type so we don’t under-vaccinate you, which leads to the possibility of the efficacy of the drug being compromised, or we overdose you based off how much lettuce is [eaten]," said Republican state Rep. Scott Cepicky during a House committee meeting in February, WKRN-TV reports.

Cepicky said that the bill, which local media described as a move targeting "vaccine lettuce," would classify foods modified to act as vaccines, as pharmaceuticals.

"So if you want to consume them you would go to your doctor and get a prescription," he said.

In a 2021 press release, UC Riverside associate professor of Botany and Plant Sciences, Juan Pablo, said "We are testing this approach with spinach and lettuce and have long-term goals of people growing it in their own gardens," adding "Farmers could also eventually grow entire fields of it."

According to Pablo, "Ideally, a single plant would produce enough mRNA to vaccinate a single person."

Another researcher, Nicole Steinmetz, said in the same release that they planned to use nanoparticles or "plant viruses, for gene delivery to plants."

When asked by WKRN-TV about the status of the research, a UC Riverside spokesperson said that the project is not yet complete.

"Research into the process of having plant chloroplasts express vaccine chemistry is ongoing. There are no definitive results to report," said Jules Berinstein after the Tennessee bill was passed.

Democrat Senators oppose

During the debate on the Tennessee Senate Floor, some lawmakers questioned the need for the bill.

"Does the sponsor know of any instances of there being food offered in the state of Tennessee that contains vaccines in some kind of a retail or public forum?" asked state Sen. Heidi Campbell.

Rep. Cepicky hit back, highlighting in February that a Kentucky company has already been "infecting growing tobacco plants with a genetically modified coronavirus" to see if it can produce antibodies for a potential vaccine, adding that the company "can already do this right now."

Massie sounds the alarm

In 2023, US Rep. Thomas Massie (R-KY) raised concerns over the use of federal money to create "transgenic edible vaccines," which would transform edible plants such as spinach and lettuce into mRNA vaccine delivery vehicles.

In September 2023 during a debate over an appropriations bill, Massie highlighted an incident in which an edible vaccine was introduced into a corn crop used to feed pigs in order to mitigate diarrhea. The corn crop, however, became commingled with a soybean crop - contaminating 500,000 bushels that had to be recalled.

"Do we want humans eating vaccines that were grown in corn meant to stop pigs from getting diarrhea? I don’t think we want that to happen. Yet that almost happened, and it could happen," said Massie. "There is another case where the pollen cross-contaminated another crop of corn, and 155 acres of corn had to be burned. What are the cases where we’re not discovering this? I think it’s dangerous to play God with our food."

https://www.zerohedge.com/medical/tennessee-lawmakers-pass-bill-targeting-mrna-vaccines-food

Construction worker who sucker-punched disabled NYC man blames attack on diabetes, could skirt jail time

 A construction worker accused of pummeling a disabled man in a Manhattan building elevator is blaming the brutal attack on his diabetes — and could skirt jail time under a sweetheart plea deal, The Post has learned.

Andrew Caban, 49, claimed he was suffering from a hypoglycemic episode when he sucker-punched 61-year-old Richard Regen on Feb. 2, 2023 as the victim was heading to rehab for a stroke from two years earlier.

“I’ve suffered diabetes for a very long time from a very young age. I’ve had hypoglycemic episodes previously, and I’m so sorry this has happened,” Caban said in Manhattan Criminal Court on Monday. “I was reckless. There were no intentions at all — I had no intentions to harm him.”

Andrew Caban pleaded guilty to reckless assault in the third degree for sucker punching Richard Regen in an elevator.Steven Hirsch

Speaking to The Post after the hearing, Regen’s wife ripped the excuse as an example of the “Twinkie defense” — and said her husband has diabetes himself and has never acted the way Caban did in the elevator of the couple’s West 23rd Street building.

The attack was captured on the building surveillance cameras, showing Caban landing a knock-out blow and then casually walking out of the elevator, leaving Regen lying unconscious on the elevator floor.

Caban, who could have faced up to a year in jail, pleaded guilty to reckless assault in the third degree, a misdemeanor, as part of a deal with the Manhattan District Attorney’s Office that could see him get off with just a slap on the wrist.

“He is a father of a daughter. He is genuinely remorseful for what he did and this is his first criminal offense,” Assistant District Attorney Daniel Robinson told Judge Michael Gaffney when probed about the offer.

The elevator attack was caught-on-camera by surveillance video obtained by The Post.Courtesy of Merson Law PLLC

The prosecutor acknowledged that Regen was left with “ongoing trauma, probably for the rest of his life,” during the attack, but still stood by the deal in which Caban would get time served and a restraining order to stay away from the victim.

His defense attorney Effie Blassberger claimed Caban suffered a “well documented” hypoglycemic episode and that the brazen attack would have never happened had his diabetes been in check during the encounter in the West 23rd Street elevator.

As he issued the half-hearted apology, Caban claimed his life “changed as much as Mr. Regen’s” — drawing scorn and shocked laughter from the victim’s relatives, who sat in the gallery.

“He’s a really good actor,” one of Regen’s family members quipped, shortly before Caban claimed he didn’t “fully recall” what happened during the attack due to his “condition.”

Regan was also in court — and his wife, Lili Regen, delivered an impact statement on his behalf.

“My husband has completely lost his independence, his cognitive skills, the stability of his health forever by the permanent damage caused by a human fist crushing his skull into his brain,” she said.

Caban said he doesn’t remember anything from the attack — and blamed it on his diabetes.Courtesy of Merson Law PLLC

“The shock and repercussions remain constantly and will never go away.”

Lili Regen told The Post outside the courtroom that her husband, a former journalist and screenwriter, has suffered from repeated seizures and has been hospitalized four times — including a 30-day stay — since the attack.

She called Caban’s diabetes excuse a “Twinkie defense,” a mocking term for a questionable legal defense.

Regen — who already struggled with a neurological disability after a stroke from two years prior — had to undergo brain surgery after the incident.Courtesy of Merson Law PLLC

The Regens filed a lawsuit against Caban and the construction company that employed him, M Daddio, Inc. and the building owner and management companies for unspecific damages.

Lawyers for Regen have said that he was hospitalized for eight days while he suffered a brain bleed, traumatic brain injury and seizures.

He later had to undergo brain surgery to repair his damaged skull, according to his wife.

Lili and Richard Regen filed a lawsuit against Caban, his employer, the building owner and the building’s management company.Steven Hirsch

When asked what it was like to see his attacker in court, Richard Regen replied to the question by recalling the elevator attack.

“I wanted to leave,” he said. “I wanted to just leave and the guy hit me. I was so mad, so mad. He wanted to hit me.”

The civil case is pending.

Caban’s next court date in the criminal case is May 31.

https://nypost.com/2024/04/02/us-news/construction-worker-who-sucker-punched-disabled-nyc-man-inside-elevator-blames-attack-on-diabetes/

Climate Alarmists Battle To Censor Film Exposing 'Climate Crisis Scam'

 by Katie Spence via The Epoch Times (emphasis ours),

It’s been a little over a week since “Climate: The Movie,” a documentary produced by Thomas Nelson and directed by Martin Durkin, was released on Vimeo, YouTube, Rumble, and other platforms. And already, it’s garnered millions of views and thousands of reviews.

Watch this documentary to understand the lies, the pseudoscience, but also the self-interest of government-funded parasites pushing climate alarmism,” Maxime Bernier, the founder and leader of the People’s Party of Canada, posted on X, formerly known as Twitter, about the film that details how “an eccentric environmental scare grew into a powerful global industry.”

“The final nail in the coffin for the ‘human-induced climate change’ scam. An absolute MUST-WATCH!” Wide Awake Media posted on X while linking to the movie, which features an elite list of scientists, including Nobel Laureate John Clauser, Richard Lindzen, emeritus professor of meteorology at MIT, and Steven Koonin, a theoretical physicist and professor at NYU’s Tandon School of Engineering.

Still, not all the responses have been positive.

“I’m a Dutch science journalist, and I watched [Climate: The Movie],” Maarten Keulemans posted on X. “It’s full of crap.”

Some reviewers went so far as to call for censorship.

“I’m thinking we can get 10,000 people to report ‘Climate: The Movie’ on YouTube as having harmful and misleading content,” Eliot Jacobson, a retired mathematics and computer science professor, posted on X on March 23.

Following Mr. Jacobson’s call, Vimeo removed the video from its platform on March 24citing a “violation of Vimeo’s Terms of Service and/or Guidelines.”

The [V]imeo link to ‘Climate the Movie’ I shared two days ago has been censored!” Nir Shaviv, a physics professor at the Hebrew University of Jerusalem who appeared in the film, posted on X. “Fully removed beyond the mere shadow blocking [YouTube] has.”

Neither Mr. Durkin nor Mr. Nelson were surprised.

“There’s something bigger going on behind the climate thing, beyond the narrow arguments about whether it’s true that [carbon dioxide] causes all this stuff—which, of course, it doesn’t,” Mr. Durkin told The Epoch Times. “There’s almost a blanket ban on skepticism on mainstream television.

It’s a kind of Marxism, I suppose. There’s an entire class of people who have an interest in high levels of taxation and high levels of regulation, in what might broadly be termed the ‘publicly funded establishment’ and the ‘education establishment.’”

Mr. Nelson concurred. “There’s a big difference between the climate realists and the other side,” he told The Epoch Times. “[Climate alarmists] are constantly reporting us and tattle-telling on people that don’t agree with them.

“I never see [climate realists] saying, ‘let’s report people from the other side, and let’s take down their videos, let’s censor them.’ All the censorship is coming from one side, and all the free speech and ‘let’s debate’ is coming from our side. We want to talk about it because we’re confident with our evidence.”

Censorship Unchecked

Immediately after Vimeo removed Mr. Durkin’s film, he reached out to the platform, “You know, I’m a reasonably well-known, veteran filmmaker, award-winning,” he said. “And I told them [via an electronic form], ‘Look, all the archive and music is cleared. We see absolutely no reason whatsoever why this was suspended. We’ve got a lot of good scientists in it.”

Mr. Nelson posted to X, “Hey @Vimeo: Specifically what is your justification for censoring ‘Climate: The Movie’?”

“A lot of people said they couldn’t believe it was being censored,” Mr. Nelson said. “But I never got an official response from anybody.”

Mr. Durkin didn’t get a response, either. “About 12 hours after I reached out, it went back up again. But we don’t know why. I presume that some ‘greens’ complained about it and that they automatically took it down. Fair dues to Vimeo that they put it back up, though, that was good.”

Vimeo wasn’t the only platform to take action against “Climate: The Movie.” On March 22, Food Lies, which has 44,000 subscribers, reported that when they first shared the movie on their channel, YouTube “immediately” removed it, and Food Lies had to seek special permission to repost.

When the report was granted, YouTube added the following contextual warming, “Climate change refers to long-term shifts in temperatures and weather patterns. Human activities have been the main driver of climate change, primarily due to the burning of fossil fuels like coal, oil, and gas,” and included a link to the United Nations’ “What is Climate Change?” website.

Further, Mr. Nelson said he believes Google is censoring the movie’s website. “We may have been shadow-banned, but we can’t prove it either way,” he said. “I don’t think Google wants to direct people to our site.”

However, Mr. Nelson and Mr. Durkin agree that the purchase of Twitter by Elon Musk in 2022 changed the social media censorship game.

I love the fact that X is open right now, and we’re able to talk freely on X,” Mr. Nelson said. “Because just two years ago, if this had come out when we were all suppressed, it would have made a big difference.”

“[Social media] is not so much a problem,” Mr. Durkin said. “Social media is leaky enough now that it gets out there.

“The bigger point is that I pitched this idea to the BBC and Channel Four about a year before I [was on Tom Nelson’s podcast]. Why, I have no idea. I knew they'd say no, but I think I wanted to satisfy myself. And, of course, they did say no.”

Mr. Durkin said that even if a station wanted to air a story expressing skepticism about the “climate crisis,” broadcast regulators in Canada, and the UK can destroy that station.

“In effect, they’re saying, ‘If you put out skeptical views, you’ll be sanctioned.' And that can go as far as to have your broadcasting license revoked,” Mr. Durkin said. “So, you know, this is full-scale state censorship on mainstream media, and [the general public isn’t] making a fuss. We’re just sort of accepting that this is the case.”

Paying the Social Cost

When asked why “Climate: The Movie” has received such pushback, Mr. Durkin said it boils down to what he terms the “New Class.”

“Many of these characters have built their careers on the climate scam,” he said. “I mean, their reputations, their livelihoods, everything depends on it, and so they feel enormously threatened.

“But beyond that, there’s this kind of political-ideological movement; it’s not just about the weather. And the people who promote it—most of science is publicly funded, and lots of scientists are involved directly with publicly funded institutes—are part of that publicly funded establishment, so they have that worldview.

“You know, if you look at the political analysis of people in universities, they are 99 percent Democrats, or left-wing even.

“And it’s now de rigueur in those circles to hate Trump, to believe that more regulation is a civilized thing, to think that public backing for the arts, is a good thing, and so on and so forth. And when you come out and say that you don’t think the climate thing is true, you’re not just making a narrow point about the medieval warm period, or the geological record, on temperature, you’re saying something much bigger, ideologically.

“You’re saying that maybe Trump’s not so bad. And the Second Amendment is a good idea. And you’re suddenly lumping yourself in with the deplorables and people in pickup trucks. And if you’re in Britain with Brexiteers. You’re putting yourself in a whole other social caste, as it were.”

Mr. Durkin said that before the release of the film “The Great Global Warming Swindle,” in 2007, which  the head of science at Channel Four asked him to make, he was considered to be one of the “hottest science documentary producers around,” and was regularly tasked by Channel Four to produce films. But after that film’s release, it took three years before Channel Four asked him back.

He said the regular invites to dinner parties and social gatherings in London“media and academic types” dried up.

“My wife was extremely cross. There was a huge backlash, and she has really bad memories of the immediate aftermath of putting ‘Swindle’ out, and that’s why she was very, very reluctant to have me make another film,” Mr. Durkin said.

“So that part of the film, where we talked about the social cost of coming out against climate in terms of ostracism from a particular social class, the New Class, that was personal.”

The New Class

Mr. Durkin, who is publishing a book that takes a deep dive into the “New Class,” said one of the characteristics of that group is they consider themselves to be part of the intelligentsia. By that, he means those who have a university degree that has “very little application in the real world.”

“They hate capitalism because capitalism hates them, and the market hates them,” he said. “If you do a degree in sociology, what use are you to man or beast? If I’m running a lawnmower company, I do not need anyone with a degree in sociology.

“So, they resent that they’re not well received in the marketplace. And historically, they’ve embraced the state because it provides them with an income and a gratifying grand title if they’re working for some big government agency or forum: for the U.N., or an NGO, or for NOAA, or whatever.”

Mr. Durkin said the class is at odds with the working class and is “enormously powerful” because it’s part of the publicly funded establishment.

Until we understand that they are a particular group, they have a particular set of interests, and those interests involve taking away our money and taking away our freedom, then we’re in trouble,” he said.

“I keep telling people, incredibly, in the US and the UK, more than twice as many people work in government as work in manufacturing.

“If you told some American in the early part of the 19th century that that could ever happen, they would have thought you were absolutely nuts.”

https://www.zerohedge.com/weather/climate-alarmists-battle-censor-film-exposing-climate-crisis-scam