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Friday, April 25, 2025

Trump administration to restore foreign students' legal status, for now

 The Trump administration said on Friday that it is restoring the previously terminated legal statuses of hundreds of foreign students in the United States while it develops a new policy that will provide a framework for potentially ending them in the future.

The decision was announced during a court hearing before a federal judge in Boston who is presiding over a challenge by one of the many international students across the country who is suing over actions the administration took against them as part of Republican President Donald Trump's hardline crackdown on immigration.

Their legal status had been revoked as a result of their records being terminated from a database of the approximately 1.1 million foreign student visa holders, putting them at risk of deportation.

Since Trump took office on January 20, records for more than 4,700 students have been removed from the U.S. Immigration and Customs Enforcement-maintained database known as Student and Exchange Visitor Information Systems (SEVIS), according to the American Immigration Lawyers Association.

The database monitors compliance with visa terms and records foreign students' addresses, progress toward graduation and other information. To remain in the database, student visa holders have to obey conditions like limits on employment and avoiding illegal activity.

In court filings, the administration had said that it could end students' eligibility to be in the U.S. if they, for example, turn up in a criminal history search.

But hundreds of students in lawsuits filed in recent weeks said their records were terminated based on charges that had been dismissed or for minor offenses when legally their status could only be revoked if they were convicted of violent crimes.

Over 200 students removed from SEVIS have won court orders temporarily barring the administration from taking actions against them, according to a Reuters count, including Boston University student Carrie Zheng.

Shortly before a Friday hearing in her case, U.S. District Judge F. Dennis Saylor said he had received an email from a lawyer from the government alerting him to a change in position by ICE.

According to that email, ICE was now "developing a policy that will provide a framework for SEVIS record terminations." Until that policy is issued, the SEVIS records for Zheng and similarly situated plaintiffs will remain active or will be restored, the email said.

The email said ICE maintains the authority to terminate students' SEVIS records for other reasons, including if they engage in other unlawful activity that would render them deportable.

U.S. Department of Homeland Security spokesperson Tricia McLaughlin in a statement said the agency, which oversees ICE, did not reverse course on visa revocations but restored SEVIS access "for people who had not had their visa revoked."

Saylor said that given that the reactivation of the SEVIS records for the students would take some time, he would extend a temporary restraining order he previously issued barring immigration officials from arresting or deporting her.

Zheng's lawyers did not respond to a request for comment.

https://www.aol.com/news/trump-administration-restore-foreign-students-161111246.html

Novo Nordisk wins case to kick knockoff Ozempic off the market, but it may not last

 Novo Nordisk (NVO) won a key case Thursday to stop some compounding pharmacies from selling knockoff versions of its blockbuster GLP-1 drugs. But it won't end all compounding offerings.

The company said in a statement Friday that the ruling in Texas federal court opens the door for the US Food and Drug Administration to take action against compounding pharmacies, which are supposed to halt selling compounded semaglutide — the active ingredient in diabetes drug Ozempic and weight-loss drug Wegovy — next month.

That was the deadline set by the FDA when it declared an end to a shortage of the drugs last year. The judge denied the compounders' efforts to freeze the FDA's decision to end the shortage altogether.

The Outsourcing Facilities Association, a compounding industry trade group, said in a statement Friday it was disappointed by the ruling but intends to keep fighting through the legal process and in discussions with the FDA.

Compounders and telehealth providers have continued their offerings for both Novo's semaglutide and Eli Lilly's (LLY) tirzepatide — the key ingredient in diabetes drug Mounjaro and weight-loss drug Zepbound.

But Lilly recently sued telehealth platforms that were selling its compounded products.

Telehealth and other online platforms like Lemonaid, Ro, and Hims & Hers (HIMS) offer compounded semaglutide — and could be legally allowed to continue to do so despite the Texas ruling.

That's because there are two different types of compounding pharmacies, 503A and 503B, based on the FDA regulations that govern their operations. The latter is impacted by the ruling, according to industry experts.

The 503As, however, could exploit a loophole: They can still make semaglutide copies that are not "essential copies" of the drug. That means they can make a version of semaglutide that is not identical or nearly identical to Ozempic and Wegovy.

While the FDA allows this, it also warns on its website, "Although compounded drugs can serve an important need, they can also pose a higher risk to patients than FDA-approved drugs."

Hims owns 503A pharmacies for compounding the GLP-1s, so it could continue to offer them if the formulas are not essential copies.

Ro also uses 503A pharmacies, but it is unclear if they produce the semaglutide that Ro offers.

In a statement Friday, Ro said, "We will continue to work to ensure that our patients can access the best treatments for their individual needs and goals, and follow applicable FDA rules and regulations on compounding."

When the FDA first declared the shortages resolved, compounders said it was a huge potential loss to business. The active ingredient used in the compounded product is purchased in bulk and can cost millions. The pharmacies have had since October to sell through their stock.

Ahead of the ruling, Hims had already been shifting away from compounded offerings on its website, which has decreased its web traffic in recent months, according to client note from Jefferies analyst Glen Santangelo earlier this month.

"We believe this was necessary to stay out of regulatory/IP crosshairs. This shift has started to weigh on web traffic," he wrote.

Hims stock fell 3% in after-hours trading Thursday and extended its decline Friday, down less than 2%. Novo's stock also fell more than 3% in after-hours trading Thursday, and was down nearly 2% Friday.

https://finance.yahoo.com/news/novo-nordisk-wins-case-to-kick-knockoff-ozempic-off-the-market-but-it-may-not-last-184547572.html

RFK Autism "Controversy" Is Manufactured Outrage... Plain And Simple

 by Corinne Clark Barron via American Greatness,

By now, you’ve probably seen the clip that launched a thousand self-righteous Instagram reels. 

Robert F. Kennedy Jr. dared to say something uncomfortable about autism—specifically, the profound kind—and the internet lost its collective mind.

Here’s what he said:

“Autism destroys family. And more importantly, it destroys our greatest resource, our children. And these are kids who will never pay taxes, they’ll never hold a job, they’ll never play baseball, they’ll never write a poem. They’ll never go out on a date. Many of them will never use a toilet unassisted. We have to recognize we are doing this to our children and we need to put an end to it.”

It doesn’t take a genius—or even a full listen—to understand that he was referring to severe, nonverbal, profoundly disabling autism. Not quirky software engineers or brilliant kids who need a little extra support in school. And yet, the outrage machine went into overdrive. Moms on X and Instagram rushed to share glowing tributes to their high-functioning children on the spectrum, explaining how autism is their family’s greatest blessing. And you know what? That’s beautiful. But that’s also not what RFK was talking about.

This wasn’t a sweeping statement about every autistic person. 

It was a serious moment about a serious public health issue. But as usual, nuance doesn’t fit into a TikTok soundbite.

The backlash wasn’t just misplaced—it was manipulative. 

All these people who claim to be champions of neurodiversity suddenly can’t tolerate a conversation about the darker, more painful realities many families face. They took a statement meant to elevate the need for answers and twisted it into a personal insult.

And here’s where it gets rich: many of the loudest critics belong to the same liberal cohort that routinely defends aborting children with Down syndrome or other detectable conditions. 

We’re supposed to believe they’re the defenders of all life now? Spare me.

These libs will write a tearful thread about autism acceptance, then turn around and shout down anyone who dares to ask why so many children are being diagnosed with it in the first place.

The truth is, they don’t want a solution. They want a platform. They want to be seen as more compassionate than you, especially if it means ignoring the moms who are absolutely drowning trying to care for a nonverbal 12-year-old who can’t sleep through the night, can’t be left alone, and may never live independently. RFK was speaking to those parents. The ones who love their kids desperately but who are desperate for answers too.

If RFK had gone the other direction and said, “Autism isn’t a big deal,” these same people would be screaming that he wasn’t taking the challenges of raising autistic children seriously. 

It’s not about the message—it’s about being mad. 

These people are outrage machines running on bad faith and buzzwords.

RFK didn’t say anything cruel. He said something real. And in politics today, that’s more offensive than anything else.

https://www.zerohedge.com/medical/rfk-autism-controversy-manufactured-outrage-plain-and-simple

Short-term antibiotic use linked to long-lasting resistance in gut bacteria

 Stanford University researchers report that ciprofloxacin use drives persistent antibiotic resistance in human gut bacteria, with resistance emerging independently across diverse species and enduring for over 10 weeks.

Antimicrobial resistance (AMR) is a global health concern linked to millions of deaths each year. It is widely driven by excessive and inappropriate antibiotic use. Past efforts to study AMR have largely relied on in vitro experiments and animal models, which fall short in replicating the full complexity of human microbial environments.

In the study titled "Brief antibiotic use drives  towards low-cost resistance," published in Nature, researchers performed a longitudinal metagenomic study to explain how resistance evolves in vivo.

Sixty  received ciprofloxacin, 500 mg twice daily, for five days. Over a 20-week period, participants collected 16 stool samples, yielding 960 samples for analysis. Shotgun metagenomic sequencing was performed on all samples, generating an average of 18.8 million reads per sample. A computational tool named PolyPanner was developed to identify true polymorphic sites across time.

Researchers reconstructed 5,665 genomes representing commensal bacterial populations and identified 2.3 million genetic variants. Among these, 513 populations exhibited selective sweeps, clear evidence of adaptive evolution. A high concentration of  occurred in gyrA, a gene associated with fluoroquinolone resistance.

Among the 513 evolving populations, sweeping genetic changes frequently occurred in gyrA, a gene central to fluoroquinolone resistance. Sixty-three populations across 34 participants exhibited gyrA mutations, which typically arose independently within individuals. Nearly 10% of initially susceptible bacterial populations acquired resistance through these mutations.

Once established, gyrA sweeps persisted beyond 10 weeks and were predicted to remain detectable for up to a year. Additional resistance-associated mutations occurred in other genes, though these events were less common and appeared in fewer species.

Resistance was more likely to emerge in populations that were abundant before treatment and experienced significant declines during exposure, identifying a condition correlated with higher odds of evolutionary change.

Resistance mutations did not come with fitness costs, allowing resistant strains to retain a dominant population after treatment concluded. Targeted sequencing showed no evidence of resistance reversion. Mutations in gyrA accounted for only part of the observed resistance, suggesting additional mechanisms.

Based on the results, even short-term antibiotic use can lead to resistance mutations that persist in the human gut for months after treatment ends. Mutations arise independently across  and do not incur a measurable fitness cost, allowing resistant strains to remain prevalent.

Gut microbes proved capable of evolving resistance without prior infection. Commensal populations may therefore act as reservoirs for resistance traits that could transfer to  through  beyond the interaction with antibiotics.

Because resistance evolved predictably based on population size, it allows for the possibility of predicting resistance outcomes if the starting population is known in advance of treatment. Experiments with differing admixes of starting populations and treatment types are needed to fully expand this predictive modeling.

Monitoring microbial composition and abundance before and during  could help guide more precise antibiotic use, reduce long-term risks associated with resistance and improve overall stewardship of antibiotic use.

More information: Eitan Yaffe et al, Brief antibiotic use drives human gut bacteria towards low-cost resistance, Nature (2025). DOI: 10.1038/s41586-025-08781-x


https://medicalxpress.com/news/2025-04-short-term-antibiotic-linked-resistance.html

'Three minutes of moderate activity a day may reduce risk of cardiovascular event'

 A team of cardiovascular and public health researchers affiliated with multiple institutions across the U.K. and one in Australia, working with Mackenzie Wearables Research Hub, has found that for older people, just three minutes a day of moderate incidental activity may reduce their risk of experiencing a cardiovascular event such as a heart attack, and also death from such an event

In their study published in the journal Circulation, the group analyzed information in the UK Biobank for people who wore wrist monitors that tracked their activity levels.

Prior research has shown that with age, many people reduce their physical activity, increasing their chances of experiencing a cardiovascular event. Some have been found to reduce exercising to near zero. In this new effort, the research team noted that many activities may not be thought of as , such as doing household chores or going shopping for groceries, but they might be giving health benefits regardless. The researchers refer to such actions as incidental activities.

To learn more about this possibility, they accessed data for 24,139 people (with a mean age of 62 years) listed in the UK Biobank, who had worn accelerometers on their wrists for at least seven days over the years 2013 and 2015 and who self-identified as non-exercisers. They compared those whose wrist monitors showed they engaged in regular moderate activity with those who were more or less active. They found that those people who engaged in regular moderate incidental activity measurably lowered their likelihood of experiencing a cardiovascular event or dying from one.

More specifically, the team found that people who were moderately active for at least three minutes on a regular basis reduced their chances of having a , stroke or other type of cardiovascular event. They also found —men, for example, were found to engage in fewer incidental activities than women. They also observed health improvements as the number of incidental activities increased and when such activities were more intense.

The team suggests that people can reduce their chances of having a  as they age by participating in daily incidental activities, such as preparing meals instead of going out, keeping the house clean, mowing the lawn or doing some gardening. The key, they note, is to try to do several short-duration activities every day.

More information: Emmanuel Stamatakis et al, Dose Response of Incidental Physical Activity Against Cardiovascular Events and Mortality, Circulation (2025). DOI: 10.1161/CIRCULATIONAHA.124.072253


https://medicalxpress.com/news/2025-04-minutes-moderate-day-cardiovascular-event.html

Unity Biotech: Alternative to Anti-VEGF Shows Safety, Efficacy in Diabetic Macular Edema

 

  • A single intravitreal injection of UBX1325 (foselutoclax) was shown to be safe in patients with diabetic macular edema.
  • The drug also showed potential efficacy in patients who failed to optimally respond to anti-VEGF treatment.
  • Results of a phase IIb trial comparing UBX1325 to anti-VEGF therapy are expected later this year.

A single intravitreal injection of UBX1325 (foselutoclax), a novel senolytic small molecule inhibitor, had a tolerable safety profile and "trends suggestive of potential efficacy" in patients with diabetic macular edema (DME) who failed to optimally respond to anti-vascular endothelial growth factor (VEGF) treatment, a phase II sham-controlled trial showed.

Among 65 patients followed for up to 48 weeks, five grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in the UBX1325 group, all of which were considered serious, while four TEAEs occurred in the sham group, three of which were considered serious, reported Przemyslaw Sapieha, PhD, of UNITY Biotechnology in San Francisco, and colleagues in NEJM Evidenceopens in a new tab or window.

In regard to efficacy, a secondary outcome, the difference between UBX1325 and sham in mean change to week 48 in best-corrected visual acuity was 5.6 more Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (95% CI -1.5 to 12.7).

The drug "seems to have a safer profile than anti-VEGF, and it led to sustained improvements in vision lasting up to a year," Sapieha told MedPage Today.

He pointed out that frequent anti-VEGF injections into the eye can be a significant burden, and many patients with DME are of working age. In addition, anti-VEGF agents can cost thousands of dollars per injectionopens in a new tab or window, and patients may need monthly treatments.

UBX1325 works by eliminating cells that become dysfunctional in DME and produce inflammatory factors, Sapieha said, adding that the mean vision improvements in the study are clinically significant, equal to a line of vision, and subgroups with less severe cases gained 10-15 letters.

A small pilot study previously showedopens in a new tab or window that UBX1325 achieved sustained improvement in visual acuity in patients with DME or neovascular age-related macular degeneration.

While anti-VEGF agents have become a standard therapy, Emily Y. Chew, MD, of the National Eye Institute, noted in an accompanying editorialopens in a new tab or window that they're "far from a perfect treatment."

"For example, in one trialopens in a new tab or window, while ranibizumab [Lucentis] treatment resulted in a mean gain of 10 letters on the visual acuity chart, only half of the trial population achieved this visual acuity gain," Chew wrote. "Furthermore, a secondary analysisopens in a new tab or window of a trial of three different anti-VEGF drugs demonstrated persistent diabetic macular edema following monthly injections of these drugs for 6 months, ranging from 32% to 66%, while 16% to 29% of participants in the trials had reduced visual acuity accompanying this persistent edema."

Chew said that the "relatively small" new trial shows that "intravitreous injection of foselutoclax was not associated with worrisome safety signals and the secondary outcomes suggest that foselutoclax may warrant further investigations to assess potential efficacy."

She said that the loss to follow-up rate was higher than anticipated, possibly because patients in the sham arm sought treatment elsewhere. "Thus, it may have been more appropriate and a fairer comparator to have an active anti-VEGF treatment as the comparator with foselutoclax," she wrote.

Results of a phase IIb trial comparing UBX1325 to anti-VEGF therapy are expected later this year.

From June 2021 to April 2022, Sapieha and colleagues randomized 65 participants with DME and prior suboptimal response to anti-VEGF treatment to either UBX1325 (n=32) or sham (n=33). Mean age was 62.5, 67.7% were men, and 75.4% were white.

Participants received an average of four anti-VEGF injections in the 6 months prior to trial enrollment, with the last injection ranging from 3 to 6 weeks prior to randomization.

As for study limitations, the researchers highlighted the dropout rate of 25% by week 48 and noted that "other definitions of suboptimal response" to anti-VEGF agents could lead to different results. "Moreover, the patient population best suited to UBX1325 is still being explored and alterations to the patient population could also influence response," they wrote.

isclosures

The study was supported by UNITY Biotechnology.

Sapieha is chief scientist with UNITY Biotechnology. Some co-authors disclosed employment and consulting relationships with the company, and some had other disclosures.

Chew disclosed relationships with Merck, NGM Bio, Genentech, 4DMT, and Bionic Sight.

Primary Source

NEJM Evidence

Source Reference: opens in a new tab or windowKlier S, et al "Safety and efficacy of senolytic UBX1325 in diabetic macular edema" NEJM Evid 2025; DOI: 10.1056/EVIDoa2400009.

Secondary Source

NEJM Evidence

Source Reference: opens in a new tab or windowChew EY "Foselutoclax (UBX1325) for diabetic macular edema -- a potential novel therapy?" NEJM Evid 2025; DOI: 10.1056/EVIDe2500004.


https://www.medpagetoday.com/ophthalmology/generalophthalmology/115290

LA To Institute Mass Layoffs Of City Workers In Wake Of $1 Billion Deficit

 For many years now the narrative on California is that it is a country unto itself and it generates so many tax dollars the federal government and red states should be throwing a garden party in its honor.  In reality, California is not a "donor state" as the Rockefeller Institute claims.  It can't even support itself, let alone bolster the rest of the country.

This problem has become more evident in the past year as Los Angeles hits a budget deficit of a billion dollars and, the state government doesn't have the funds to help the city recover because of it's own $68 billion deficit.

In response to the lack of aid from the state or federal government, Los Angeles Mayor Karen Bass unveiled a proposed $13.9 billion municipal budget for fiscal year 2025-26, which includes more than 1,600 layoffs and the consolidation of four city departments in an effort to eliminate the overdraft.  Though LA employs around 50,000 people in total and the layoffs might seem minor in comparison, the city's expansive programs require employee growth this year, not cuts. 

Furthermore, it is likely that the 1600 fired workers are just the beginning.  The city removed at least 2000 positions from its employee roster at the end of last year and is already moving to make cuts to existing workers.

It's no coincidence that LA is in fiscal trouble in 2025, and it's not only because of the $2 billion in damages associated with the recent wildfires.  After decades of decadent debt spending CA is deeply dependent on federal funds.  Federal budget cuts and the shutdown of agencies like USAID are having far reaching consequences, especially in progressive states with a heavy emphasis on socialized programs.  

For example, the federal Department of Health and Human Services recently terminated $12 billion in grants intended for infectious disease response, mental health services and other public health issues.  At least $1 billion of this cash was supposed to go to California in 2025.  Covid money is funneled into various health departments and other projects and California was the biggest recipient of pandemic funds by far with over $77.8 billion received through the state government and over $600 billion in total relief.  Some critics argue that covid relief in California was wrongly exploited as a financial boon for various state agencies, politicians and employees.

Now the pandemic funding is finally cut off after 5 years.  $45 million of the $1 billion lost was supposed to go to Los Angeles. 

The LAPD is also losing over $10 million due to federal funding cuts.  The agency and city officials are trying to sort out the potential impact of being cut-off from millions of dollars in law enforcement and homeland security grants, following the US Justice Department’s announcement such programs would be suspended for any municipality that considered itself a so-called, “sanctuary city,” that bars local officers from playing a role in immigration enforcement.

The Orange County Register reported last month that Orange County will lose out on more than $68 million in federal earmarks for 2025, money that was previously approved for community projects.

California schools have been warned by the Trump Administration that if they don't stop instituting DEI programs and indoctrination, they will lose at up to $16 billion in funding, with $1.26 billion of that going to the Los Angeles Unified School District.

The sheer enormity of federal funds floating around California should be taken into account, but also the fact that despite access to so much money California and LA are still facing a massive budget shortfalls.  The chances of this dilemma being solved through layoffs and department consolidation is next to nil.  The real root of the problem is policy driven; Democrat welfare programs, social programs and their open border mentality have resulted in a never ending drain on their finances, slowing destroying what was once one of the greatest states in the nation.

https://www.zerohedge.com/political/la-institute-mass-layoffs-city-workers-wake-1-billion-deficit