Leaks hindered immigration raids in Colorado: Homan

 Tom Homan, President Trump’s “border czar,” is seething after an immigration raid in a suburb of Denver was allegedly leaked, allowing targets in the Venezuela-linked Tren de Aragua (TDA) gang to escape.

“This isn’t a game. We know that TDA is dangerous,” Homan said Thursday in a statement to reporters outside the White House.

“Everybody can agree to that, but when they get a heads-up that we are coming, it’s only a matter of time before our officers are ambushed,” he added, according to The Associated Press. “Their job is dangerous enough. So we are going to address this very seriously.”

Immigration and Customs Enforcement (ICE) officers were still able to carry out some arrests, though the number of individuals detained remains unclear. The agency has been actively documenting their deportation efforts via social media. 

“100+ members of the violent Venezuelan gang Tren de Aragua were targeted for arrest and detention in Aurora, Colo., today by ICE and its partners @FBI @DEAHQ @CBP @ATFHQ & @USMarshalsHQ in an ongoing investigation,” the agency wrote Wednesday in statement on the social platform X.

Agents raided an apartment complex frequented by gang members where several individuals died due to alleged fentanyl overdoses, AP reported. A local judge has identified the site as a public safety threat and ordered its closure by Feb. 18.

ICE averaged 787 arrests per day from Jan. 23-31. 

The arrests come after the Department of Homeland Security (DHS) authorized the agency to carry out arrests in schools and churches late last month, rescinding a previous guideline that barred arrests in these “sensitive” areas. Denver Mayor Mike Johnston (D) argued that the move infringed on the city’s public safety.

“It’s all for the good of this nation, and we’re going to keep going. No apologies,” Homan told Fox News in an interview last month, responding to Johnston’s complaints. “We’re moving forward.”

The two men have been at odds since the administration began acting on Trump’s pledge to executive mass deportations. The border czar even threatened to put the mayor in jail if he refuses to cooperate with the president’s immigration orders.

The Hill has reached out to the Department of Homeland Security for additional comment.

https://thehill.com/homenews/administration/5132732-tom-homan-immigration-raids-hindered-leaks-colorado/

EPA facing monumental battery cleanup after LA wildfires

• EPA says biggest lithium ion battery cleanup in the history of the agency
• Agency has 30 day deadline to complete cleanup
• EPA removed 80 electric vehicles and bulk energy storage systems

The Environmental Protection Agency is facing a monumental challenge clearing up batteries after the California wildfires, a task they’re calling the biggest lithium-ion battery cleanup in the history of the agency. 

Southern California is the nation’s biggest market for electric vehicles EV and hybrid cars. Each EV contains about 7 to 10,000 small batteries. 

Cleanup consists of crushing and then taking the remnants to a proper site for toxic waste disposal. 

While there still aren’t concrete numbers as to how many electric vehicles will need to be cleared, officials are estimating that the number is well into the thousands. 

“EPA is undertaking the largest wildfire cleanup in the history of the agency. We’re not going to wait days or weeks or months to ramp up,” EPA Administrator Lee Zeldin, who was confirmed by the Senate for the role late last month, said in a statement. “We have over a thousand personnel on the ground to aid Californians, and our local, state, and federal partners, in Los Angeles’s recovery.”

“The Trump administration is tackling this head-on in a way that EPA couldn’t possibly be prouder to be a part of,” he added.

According to the EPA, it has completed reconnaissance at 6,022 properties affected by the Eaton and Palisades Fires. The agency has also removed 80 electric vehicles and bulk energy storage systems, which pose risks to both public safety and the environment.

Cleanup operations are expanding, with 1,050 response personnel now in the field, up from 478 last week, and an additional 280 personnel being mobilized.

The Trump administration ordered the cleanup to be completed in 30 days, which leaves EPA officials little time to undertake the massive responsibility.  

The deadly wildfire that ravaged Lahaina, Hawaii, in 2023, destroyed more than 2,000 buildings, which took the agency more than four months to clear hazardous materials. In Southern California, the EPA now faces going through nearly 15,000 structures in one month. They must also face where the toxic waste is being processed and packaged. 

Residents in areas near the Eaton fire have spoken out against a waste removal site in the area near the San Gabriel foothills saying there was no consultation or warning that the area would become an EPA processing site.

The densely populated Los Angeles area only has a few sites concave for disposal. The EPA recently added a parking lot at Will Rogers State Beach for the processing. 

As their deadline looms closer, agency workers will continue around the clock to clear out the toxic debris. 

https://thehill.com/policy/energy-environment/5133535-epa-california-wildfires-battery-cleanup/

Apple Ordered To Provide UK Gov't Access To All User Data On The Cloud

 by Ken Silva via Headline USA,

The Washington Post reported Friday that the United Kingdom’s deep state has demanded that Apple create a back door for them to retrieve all the content any Apple user worldwide has uploaded to the cloud—what would be an unprecedented erosion of online privacy and civil liberties.

Citing anonymous sources, the Post reported that the British government’s undisclosed order was issued last month. It reportedly requires Apple to give officials blanket capability to view fully encrypted material.

Typically, Apple has assisted authorities on a case-by-case basis—such as helping the FBI access a terrorist’s phone, for example. The Post noted that the access sought by the UK “has no known precedent in major democracies.”

According to the Post, the UK’s order was made pursuant to the sweeping U.K. Investigatory Powers Act of 2016, which authorizes law enforcement to compel assistance from companies to access user data.

“The law, known by critics as the Snoopers’ Charter, makes it a criminal offense to reveal that the government has even made such a demand,” the Post reported.

“Apple can appeal the U.K. capability notice to a secret technical panel, which would consider arguments about the expense of the requirement, and to a judge who would weigh whether the request was in proportion to the government’s needs. But the law does not permit Apple to delay complying during an appeal.”

An Apple spokesman reportedly declined to comment. The Post reported that Apple is likely to stop offering encrypted storage in the UK.

“Yet that concession would not fulfill the U.K. demand for backdoor access to the service in other countries, including the United States,” the newspaper added.

Western countries, including the U.S., have been pushing for total access to online user data for years.

In March 2021, for example, former FBI Director Chris Wray told the Senate Judiciary Committee that encryption was stifling his agents from investigating domestic extremism.

According to Wray and other law enforcers, tech companies should be able to build “backdoors” into their encryption that preserves privacy, while allowing for access when necessary. That, they say, strikes the proper balance between data security and national security.

However, numerous tech experts, civil libertarians, and others say that it’s impossible to build a backdoor that can’t be exploited by hackers. They also say that by banning encryption, the United States would be following in the footsteps of authoritarian countries such as China, which blocked the encrypted messaging app Signal.

“It is important to understand that any kind of back door (or front door) access for the ‘good guys’ can also be exploited by the ’bad guys,’” the pro-industry Information Technology & Innovation Foundation stated in a July 2020 report.

“For example, key escrow systems would introduce new attack vectors that could allow attackers to gain access to encrypted information, such as by compromising the system that maintains copies of the keys.”

https://www.zerohedge.com/political/apple-ordered-provide-uk-govt-access-all-user-data-cloud

Hims & Hers Faces Backlash Over Provocative Super Bowl Ad

 Hims & Hers Health (HIMS), a compounding pharmacy that makes a knockoff version of Novo Nordisk's (NVO) Wegovy, might not be out of hot water yet. On Friday, Sen. Richard Durbin (D-Ill.) and Sen. Roger Marshall (R-Kan.) sent a letter to acting Food and Drug Administration Commissioner Sarah Brenner asking the agency to investigate Hims for "misleading patients."

Novo's ad for Wegovy spends about 40 seconds of its 90-second run time spelling out possible side effects of the weight-loss drug. The Hims ad, on the other hand, doesn't include any warnings and just flashes "in small, barely legible font" that its product isn't FDA approved," the senators wrote.

"We recognize the important roles that pharmaceutical compounding and telehealth play in the health care delivery system, helping to ensure access to FDA-approved products and filling a need for more customized treatments," they said. "However, we believe there should be no disparity in pharmaceutical advertising requirements between regulated entities."

Hims stock jumped 5.1%, closing at 42.55. Shares broke out of a cup base with a buy point at 35.02 on Jan. 31, according to MarketSurge. Shares are now trading in a profit-taking zone, which runs from 42.02 to 43.78.

Hims Stock: Calling Out Pharma Players

Hims & Hers makes a compounded version of semaglutide, the active ingredient in Wegovy and type 2 diabetes drug, Ozempic. It can do this because the FDA has determined semaglutide is in shortage.

But the senators say the ad for compounded semaglutide "glaringly [omits] critical safety and side effect information."

Drugs like semaglutide and tirzepatide — the chemical backbone behind Eli Lilly's (LLY) Zepbound and Mounjaro — are well known for causing gastrointestinal side effects. But other less known potential adverse effects pancreatitis, gallbladder and kidney problems, vision changes and thoughts of suicide.

The Hims ad doesn't go into any of that.

Over Childish Gambino's antiracism chorus "This is America," the commercial calls out the pharma industry, without specifically naming Novo and Lilly.

"There are medications that work," a narrator says. "But they're priced for profits, not patients. This system wasn't built to help us. It was built to keep us sick and stuck."

https://www.investors.com/news/technology/hims-stock-hims-hers-super-bowl-ad/

Turkey Is Mulling Permanent Military Bases In Syria

 by Jason Ditz via AntiWar.com,

With Turkey focused on long-term goals in Syria that involve continuing to oppose Kurdish autonomy in the northeast, there are growing numbers of reports from Turkish officials that plans are being considered to establish new military bases inside Syrian territory.

Details are still emerging on what this might look like, and thousands of Turkish soldiers are already reported to be operating on Syrian soil, mostly targeting the Kurdish SDF.

Via Associated Press

Turkey has recently threatened invasion if the new Islamist government of Syria doesn’t eliminate the SDF.

The Islamists, the al-Qaeda-linked Hayat Tahrir al-Sham (HTS), has given multiple statements rejecting the idea of Kurdish autonomy. Turkish FM Hakan Fidan says the new HTS ruler of Syria is taking a firm stance against Kurdish "terrorists."

That the HTS is largely giving Turkey whatever they want with respect to Kurdish territory doesn’t necessarily mean Turkey won’t seek to increase its presence in the country.

The Turkish Defense Ministry, however, has denied any specific plans for bases at this time, suggesting talk of new bases may be premature.

In the meantime, the Turkish-backed Syrian National Army (SNA) continues to attack SDF territory, and Turkish warplanes and drones are attacking Kurdish towns and cities.

In the Raqqa Governorate, almost exclusively SDF territory, activists are increasingly critical of Turkish aggression.

Fighting on the ground with the SNA is still mostly further west than Raqqa, in the Aleppo Governorate. In recent weeks, the focus has been on trying to take the Tishreen Dam, and Kurdish protesters have been rally at the dam calling for international intervention to prevent the Turkish destruction of it. Tishreen Dam is a key source of fresh water and electricity for northeastern Syria.

Map of Syrian situation via Southfront.press:

Turkey has carried out multiple airstrikes against Tishreen Dam and targeted the protesters rallying there. It targeted those protesters again on Thursday, injuring an unknown number of them.

https://www.zerohedge.com/military/turkey-mulling-permanent-military-bases-syria

GSK, Pfizer sales of RSV shots slow as vaccination rates ebb

 

• Sales of both GSK’s and Pfizer’s vaccines for respiratory syncytial virus dropped significantly in the last three months of 2024, compared the same period one year before.
• In a earnings report Tuesday, Pfizer said sales of its vaccine Abrysvo fell 62% year over year in the fourth quarter. The company attributed the drop mainly to “a significant reduction in vaccination rates in the U.S.” among older adults eligible for the shot after U.S. guidelines were narrowed last summer.
• GSK reported a similar state of affairs Wednesday. Sales of its RSV vaccine Arexvy declined 69% year over year due to lower demand “related to a more limited recommendation ... for individuals aged 60 to 74,” as well “channel inventory consumption.”

GSK has been the dominant player in the RSV vaccine market since Arexvy first gained approval in 2023, although Pfizer has made inroads into its market share. While initial launches for both companies’ products were strong, sales have since been crimped by the changed U.S. guidelines.

Last year, an advisory panel to the Centers for Disease Control and Prevention recommended that adults aged 60 to 74 years who are at high risk of severe RSV disease receive a shot, narrowing the prior guidance of “shared clinical decision-making” for all adults over 60 years. The committee still advised all adults 75 years or older get vaccinated for RSV.

The drugmakers have hinted at the guidance’s impact in prior earnings disclosure, so the slowed fourth quarter sales are not entirely a surprise. In January, analysts from Jefferies highlighted in a client note how vaccination rates for RSV remained low, even as rates for COVID-19 and flu climbed.

Both GSK and Pfizer have been able to secure expanded approvals for their shots, but uptake in those groups may depend on revised recommendations. The Food and Drug Administration cleared GSK’s shot for adults aged 50 to 59 years who are at increased risk of disease, while Pfizer received an OK for its vaccine in adults aged 18 to 59 years who are at similar risk.

Abrysvo is also approved for maternal immunization, which is meant to pass on temporary protection to newborns. Uptake in that indication offset some of the fourth quarter sales decline due to “strong demand” in the setting, according to Pfizer.

The CDC hasn’t yet issued guidance on whether adults who already received either shot will need another dose later on to maintain protection from RSV. In October, Jefferies analyst Peter Welford told clients the probability of a two-year vaccination schedule for Arexvy was “low.”

Most recently, the FDA added warnings to Arexvy’s and Abrysvo’s labeling for an increased risk of a rare neurological disorder known as Guillain-Barré syndrome.

More broadly, GSK said Wednesday it will be “increasing and prioritizing R&D investment” in respiratory medicines, among other categories. It predicts low single digit declines in revenue from its vaccine unit this year, but overall expects its business to grow 3% to 5%.

https://www.biopharmadive.com/news/pfizer-gsk-record-major-drop-in-rsv-sales/739287/

Novo flunks kidney disease trial, again linking obesity prospect to neuropsychiatric side effects

 Novo Nordisk’s cannabinoid CB1 receptor blocker has run into another problem. Months after sharing obesity data that left investors underwhelmed, the Danish drugmaker has reported the failure of a midphase diabetic kidney disease trial of the molecule.

CB1 receptor blockade is an old idea—Sanofi won approval for a drug with the mechanism in 2006—but Novo identified Inversago Pharma as a company capable of realizing the potential of the approach. Novo acquired the Canadian biotech in a deal worth up to $1.1 billion in 2023. Since then, a mix of lackluster efficacy and concerning safety signals for monlunabant in obesity have taken the shine off the deal.

The program took another hit Wednesday when Novo reported a phase 2 flop. Investigators randomized 254 diabetic kidney disease patients to receive one of two doses of monlunabant or placebo. After 16 weeks of once-daily dosing, people on the study drug did no better than their counterparts on placebo on a measure of kidney function. The result caused the trial to miss its primary endpoint.

Reporting of mild to moderate neuropsychiatric side effects was more frequent with monlunabant than placebo. The safety data add to concerns that the molecule suffers from some of the same problems that held back CB1 blockers in the past. European authorities withdrew the approval of Sanofi’s CB1 obesity drug in 2009 after studies found it doubled the risk of psychiatric disorders.

Novo is yet to share safety and efficacy data from the kidney disease trial, with the only other snippet in the disclosure being the detail that the most common adverse events were gastrointestinal and the vast majority of cases were of mild to moderate severity.

Martin Holst Lange, M.D., Ph.D., the company’s executive vice president of development, told analysts on its financial call Wednesday morning that Novo wasn’t discouraged by the fail, pointing out that “we never did the acquisition of monlunabant to develop it purely for diabetic kidney disease—our focus was on the weight loss potential.”

“Second, I just remind you that that that these are small studies, so obviously, we try to see them in the context of the full picture,” he said. 

“When we look at the safety and tolerability profile, it was comparable, albeit at a slightly lower rate than in the dedicated obesity study, basically indicating that we can still have an aspiration of exploring this further in phase 2b with lower doses, looking at weight loss potential, but obviously also—and this has been the intent from the get-go—ruling out a potential safety concern.”

https://www.fiercebiotech.com/biotech/novo-flunks-kidney-disease-trial-again-linking-obesity-prospect-neuropsychiatric-side