Tuesday, May 13, 2025
Lexicon targets late 2025 Phase 3 start for pilavapadin and expands LX9851 partnership with Novo
Lexicon Pharmaceuticals (LXRX) reported Q1 2025 financial results and business updates. The company secured an exclusive license agreement with Novo Nordisk for LX9851, potentially worth up to $1 billion in payments. Their Phase 2b PROGRESS study confirmed 10 mg pilavapadin as the optimal dose for Phase 3 development in diabetic peripheral neuropathic pain. Q1 financial results showed revenues of $1.3 million, R&D expenses of $15.3 million, and reduced SG&A expenses to $11.6 million. Net loss improved to $25.3 million ($0.07 per share) from $48.4 million in Q1 2024. The company ended Q1 with $194.8 million in cash and investments. Lexicon is advancing multiple pipeline programs, including sotagliflozin for hypertrophic cardiomyopathy in the SONATA-HCM Phase 3 study.
Federal Grand Jury Indicts Wisconsin Judge Accused Of Helping Illegal Immigrant Evade ICE
by T.J.Muscaro via The Epoch Times,
Milwaukee County Circuit Judge Hannah Dugan was indicted by a federal grand jury on May 13, after being arrested and accused of helping an illegal immigrant evade Immigration and Customs Enforcement (ICE) last month.
Her indictment comes after she was arrested by the FBI on April 25 and subsequently suspended from her duties as a judge by the Wisconsin Supreme Court.
The grand jury reviewed the charges brought forth in a complaint, as a check on the prosecutor’s power, and determined that enough probable cause existed to continue the case.
Dugan faces one count of “obstructing or impeding a proceeding before a department or agency,” and another of “concealing an individual to prevent his discovery and arrest.”
Her next court appearance was previously scheduled for May 15, and she could face more disciplinary actions against her license to practice law.
According to her defense attorneys, she maintains her innocence and expects to be vindicated in court.
She was assigned to preside over a hearing for Eduardo Flores-Ruiz, a Mexican national who was charged with domestic violence, on April 18. Flores-Ruiz had previously been deported in 2013, and there was no evidence that he reentered the country legally.
The FBI agents and deportation officers planned to arrest Flores-Ruiz after the hearing.
However, according to the affidavit, witnesses said Dugan appeared “visibly upset and had a confrontational, angry demeanor,” upon learning of the arrest party’s arrival.
They alleged that Dugan “escorted” Flores Ruiz and his lawyer “out of the courtroom through the ‘jury door,’ which leads to a nonpublic area of the courthouse,” after she “ordered” the team of FBI and deportation officials to go to the chief judge’s office.
The jury door is normally used by defendants only if they are in the custody of deputies.
Another officer, according to the affidavit, noticed Flores-Ruiz and his lawyer on an elevator and alerted the arrest team.
Flores-Ruiz was apprehended after a foot chase outside the courthouse.
FBI director Kash Patel said investigators believe Dugan “intentionally misdirected federal agents” away from Flores-Ruiz, as officers were preparing to arrest him in the courthouse where the judge works.
Trump Admin Targets Journal's "Proximal Origin" Paper Dismissing Possible Wuhan Lab Accident
by Paul D. Thacker via the DisInformation Chronicle,
A brief flurry of media reports last month criticized letters sent to medical journals by Edward R. Martin Jr., the former interim U.S. attorney for the District of Columbia, who questioned whether journals have become “partisans in various scientific debates.” One liberal academic called the letters “fascist tactics” designed “to intimidate academic journals” triggering similar allegations across the media.
“Experts worry this will have a chilling effect on publications,” reported the New York Times, noting that an obscure journal called CHEST had been targeted.
“DOJ questions science journal about bias, triggering free-speech concerns,” reported the Washington Post, adding that three major publishers of medical journals, including the New England Journal of Medicine and Health Affairs, said they had not received letters, while publisher Springer Nature chose not to comment. NPR reported last week that the New England Journal of Medicine had in fact received a letter as had the American Medical Association’s journal JAMA.
The DisInformation Chronicle has learned that the actual target of Martin’s letters is the Nature Springer journal Nature Medicine, publisher of a highly controversial paper “Proximal Origin” which has faced charges of corruption and calls for retraction. A source inside the Department of Health and Human Services said Trump officials suspect the paper is a quid pro quo, written by the authors to dismiss the possibility of a lab accident and who then received a large grant months later from Tony Fauci.
The existence of the Nature Medicine letter has not been previously reported and is being made public for the first time. After Martin lost support among Republicans to be confirmed as U.S. attorney for the District of Columbia, President Trump picked him to head a new Weaponization Working Group inside the Justice Department.
Follow the science
Published in the third month of the COVID pandemic and arguing “we do not believe that any type of laboratory-based scenario is plausible,” the “Proximal Origin” paper became a handy tool for NIH officials and virologists attempting to dismiss as a “conspiracy theory” claims that the pandemic could have started in a Wuhan lab funded by Fauci. Nature Medicine’s editor-in-chief, Joao Monteiro, tweeted that the paper “put conspiracy theories” about the pandemic’s possible lab origin to rest.
NIH Director Francis Collins promoted the “Proximal Origin” paper weeks after Nature Medicine published it on his March 2020 NIH Director's Blog, and Fauci then seized upon the paper during a televised White House briefing a month afterwards.
“There was a study recently that we can make available to you,” Fauci said during the White House briefing, “where a group of highly qualified evolutionary virologists look at the sequences there and the sequences in bats as they evolve and the mutations that it took to get to the point where it is now is totally consistent with a jump of species from an animal to a human.”
The paper would go on to become one of the most heavily cited scientific papers in 2020. The Nation reported in 2023 that “Proximal Origin” had been accessed online more than 5.7 million times and more than 2,000 media outlets had cited it. ABC News, for instance, ran an article titled “Sorry, Conspiracy Theorists. Study Concludes Covid-19 ‘Is Not a Laboratory Construct.’”
But by then, cracks had already appeared.
Follow the money, follow the documents
Emails made public through freedom of information act requests and by congressional investigators in 2022 showed that the papers’ authors had run it past funders—Francis Collins and Tony Fauci at the NIH, as well as with Jeremy Farrar, who was then at the Wellcome Trust. In one example, lead author Kristian Andersen with the Scripps Research Institute emailed the three funders thanking them for their “advice and leadership” and offering them a right to comment and give suggestions.
Further emails and internal slack discussions calling into question the credibility of “Proximal Origin” became public in the summer of 2023 following a congressional hearing. During the hearing, Republicans charged that Tony Fauci had helped orchestrate the paper’s publication. However, Democrats countered by releasing a report that found Wellcome Trust’s Jeremy Farrar helped “organize and facilitate” and “led the drafting process of the paper.”
“Jeremy, Dr. Farrar has been an amazing leader,” wrote “Proximal Origin” co-author Robert Garry of Tulane University in an email released by House Democrats. “Should be author.”
When questioned about his email during a House deposition, Garry agreed that Farrar should have been listed as an author.
According to Nature’s editorial policy, “A specific role for the funder in the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript, should be disclosed.” However, the paper failed to note the involvement of either Fauci or Farrar, and Nature Medicine has refused to follow its own ethics guidelines.
News sites the Racket and Public co-published a slack message Andersen sent to his “Proximal Origin” co-authors on April 16, 2020, a month after Nature Medicine published the paper in March 2020.
“I’m still not fully convinced that no culture was involved,” Andersen wrote his co-authors, a month after publishing the paper that concluded the virus was not a laboratory construct. “We also can't fully rule out engineering (for basic research).”
Days after the congressional hearing, the group BioSafety Now wrote a letter to Nature Medicine, signed by over 50 scientists, demanding retraction of “Proximal Origin.” The letter cited an investigation published by The Nation reporting on internal emails by the “Proximal Origin” authors that showed they didn’t even believe what they wrote in the paper.
“The main issue is that accidental release is in fact highly likely,” the Nation reported that Andersen wrote in a message to co-authors some weeks before Nature Medicine published the paper. An online campaign by BioSafety Now has since garnered over 5,700 signatures petitioning Nature Medicine to retract the paper.
In his letter to Nature Medicine, Martin wrote that he has been told that some journals “have a position for which they are advocating due to advertisement (under postal code) or sponsorship (under relevant fraud regulations).”
The letter also asks, “How do you clearly articulate to the public when you have certain viewpoints that are influenced by your ongoing relations with supporters, funders, advertisers, and others?”
A source close to the investigation said this question pertains to a grant Fauci awarded Andersen and Garry several months after they published “Proximal Origin” dismissing the possibility of a lab accident. Allegations that this grant was a bribe from Fauci have dogged Andersen for several years, accusations which he dismissed under oath during the July 2023 congressional hearing.
“There is no connection between the grant and the conclusions we reached about the origin of the pandemic,” Andersen wrote in sworn testimony to Congress. “We applied for this grant in June 2019, and it was scored and reviewed by independent experts in November 2019.”
The Intercept later reported that Andersen “knew that was false.” NIH records show the grant to Andersen wasn’t finalized until May 21, 2020, two months after Andersen published “Proximal Origin” in Nature Medicine.
In a guest essay earlier this month for The DisInformation Chronicle, an NIH infectious disease researcher wrote that the “Proximal Origin” authors left a gaping hole in their analysis by failing to account for a common method to manipulate viruses called “serial passaging.”
“And because they didn’t discuss this very common laboratory practice, they did not ‘disprove’ a laboratory origin for the virus,” the NIH research official wrote. “I have no idea how ignoring something so obvious could make it pass peer review and get published in a prestigious journal like Nature Medicine.”
Federal Judge Says Trump's Invocation Of Alien Enemies Act Was Legal
by Sam Dorman via The Epoch Times,
A federal judge in Pennsylvania has said that President Donald Trump validly invoked the Alien Enemies Act in March as part of an effort to deport Venezuelan gang members.
More specifically, U.S. District Judge Stephanie Haines held that the gang - Tren de Aragua (TdA) - was engaging in the type of “predatory incursion” that the Alien Enemies Act mentions.
In an opinion on May 13, Haines noted that TdA has been designated a foreign terrorist organization.
That designation, she said, “heavily supports the conclusions ... that TdA is a cohesive group united by a common goal of causing significant disruption to the public safety of the United States.”
Haines, a Trump appointee, emphasized her “unflagging obligation is to apply the law as written.”
“Having done its job, the Court now leaves it to the Political Branches of the government, and ultimately to the people who elect those individuals, to decide whether the laws and those executing them continue to reflect their will,” Haines wrote in her 43-page ruling.
Three other district court judges have ruled against the Trump administration, stating that Trump misapplied the law with a proclamation he issued in March.
Each of those judges disagreed with Trump’s description of TdA as engaging in an invasion or predatory incursion.
The government can now proceed, so long as they provide 21-days’ notice to migrants in both English and Spanish.
“The Court recognizes that it may need to conduct further analysis and consider additional issues related to the specifics of notice in the future,” Haines wrote.
“However, at this preliminary stage of this case, the Court finds that the foregoing is appropriate and complies with the law.”
https://www.zerohedge.com/political/federal-judge-says-trumps-invocation-alien-enemies-act-was-legal
Capricor (CAPR) On Track for Duchenne Cardiomyopathy Therapy Approval
Capricor Therapeutics (CAPR, Financial) is progressing significantly towards its objective of delivering the first approved treatment for Duchenne cardiomyopathy, a condition that currently lacks approved therapies. The company is actively engaging with the FDA as it evaluates their Biologics License Application (BLA), with a target action date set for August 31, 2025, under the Prescription Drug User Fee Act (PDUFA). Preparations are underway for forthcoming FDA advisory committee meetings, pre-approval inspections, and the anticipated commercial launch.
Simultaneously, Capricor's StealthX vaccine program is poised to begin Phase 1 clinical trials in the third quarter of 2025. This initiative is spearheaded by the National Institute of Allergy and Infectious Diseases (NIAID) as part of Project NextGen, pending regulatory approval from NIAID. Financially, Capricor concluded the first quarter of the year with a robust cash reserve of approximately $145 million, positioning the company well to continue its strategic initiatives as it approaches key milestones.
EPA chief Lee Zeldin to kill stop-start car feature ‘everyone hates’
Environmental Protection Agency Administrator Lee Zeldin hinted Monday that he’s preparing to roll back one car feature that every driver “hates.”
“Start/stop technology: where your car dies at every red light so companies get a climate participation trophy,” Zeldin tweeted Monday in a post that has since racked up more than 8 million views.
“EPA approved it, and everyone hates it, so we’re fixing it.”
The feature kills internal combustion engines at red lights and has been touted by proponents for being able to conserve fuel and cut down on pollution.
Critics have questioned whether the feature can wear down the car’s battery or engine more quickly.
The “off-cycle CO2 reducing” tech has its origins in a federal rule proposed under former President Barack Obama in 2012 — but didn’t take effect until new fuel economy standards to reduce greenhouse gas emissions five years later.
Between 2012 and 2021, the number of vehicles produced with a stop-start feature due to the carbon credits surged from 1% to 45%.
Up to 65% of vehicles had the technology included in new models by 2023.
The smart start tech can improve fuel economy by between 4% and 5%, according to past EPA estimates.
But it hasn’t shown clear reductions in emissions tests, an EPA spokesperson noted.
If finalized, automakers could no longer receive any credits to produce the stop-start tech in new models.
Reps for the largest auto industry trade group, the Alliance for Automotive Innovation, did not immediately respond to a request for comment.
The move follows Zeldin targeting other tax incentives from a New York climate law and green grants from the Biden administration as part of a renewable energy push.
Zeldin charged that New York Gov. Kathy Hochul unwisely ended “safe extraction” of natural gas, gas hookups on new building construction, and gas stoves — but sought to cut sales of gas-powered vehicles and block the new Constitution Pipeline’s construction.
In January, the EPA head revealed that he found $20 billion in taxpayer money “parked” at Citibank in Manhattan after it was authorized for an array of “far-left activist groups” following the passage of Biden’s Inflation Reduction Act.
President Trump tapped Zeldin to “unleash prosperity through deregulation” with an executive order in January that designated the EPA and other agencies to eliminate at least 10 regulations for every new one proposed.
https://nypost.com/2025/05/13/us-news/epa-chief-lee-zeldin-to-kill-car-feature-everyone-hates/
Designing safe, effective nasal vaccines
Most vaccines—and boosters—are injected directly into muscle tissue, usually in the upper arm, to kickstart the body's immune system in the fight against disease. But for respiratory diseases like COVID-19, it can be important to have protection right where the virus enters: the respiratory tract.
In a new study, Yale researchers have found that nasal vaccine boosters can trigger strong immune defenses in the respiratory tract, even without the help of immune-boosting ingredients known as adjuvants. The findings, researchers suggest, may offer critical insights into developing safer, more effective nasal vaccines in the future.
"Our study shows how a simple viral protein antigen can boost respiratory tract immune responses against viruses," said Akiko Iwasaki, Sterling Professor of Immunobiology at Yale School of Medicine (YSM) and senior author of the study. "These data imply that viral proteins in nasal spray may be used as a safe way to promote antiviral immunity at the site of viral entry."
The study was published today in the journal Nature Immunology. The first author is Dong-il Kwon, a postdoctoral fellow in Yale's Department of Immunobiology.
For the study, the researchers first injected mice with a traditional mRNA COVID-19 shot, which was injected directly into the muscle. Then, the team gave the mice a booster vaccine through the nose. The team specifically wanted to evaluate the effects of vaccine boosters that don't contain special ingredients known as adjuvants. Used in some vaccines, adjuvants help stimulate a stronger, longer-lasting immune response, but they can also have adverse effects like inflammation and swelling of facial nerves.
"We call this vaccine strategy 'prime and spike,' which is where the mice were intramuscularly primed with mRNA vaccines followed by a nasal boosting with unadjuvanted spike protein," said Kwon, who is a member of Iwasaki's lab.
The Yale-developed "prime and spike" vaccine approach jump-starts immune response in the respiratory system—the first part of the body infected by COVID-19. "Prime" refers to the process of administering a traditional intramuscular vaccine shot, while "spike" refers to a follow-up vaccination delivered to the nose—usually in the form of a spray containing coronavirus-derived spike proteins.
After the first shot, immune cells became primed in the lymph nodes of the mice. After the nasal booster, B cells from the lymph node migrated to the lungs and produced immunoglobulin A (IgA), an antibody that helps protect the nose and lungs from infection. Memory CD4+ helper T cells acted as natural adjuvants by recruiting B cells and helping them secrete IgA in the lung.
Only the nasal booster triggered this strong local immune response, the researchers found. Boosters given other ways, including intramuscular injection, didn't produce much IgA or activate immune cells in the lungs of the mice. When the researchers gave the mice a second nasal booster, their IgA levels increased even more in both the lungs and nasal passages.
"These findings help explain why nasal boosters do not require adjuvant to induce robust mucosal immunity at the respiratory mucosa and can be used to design safe and effective vaccines against respiratory virus pathogens," Kwon said.
Regular COVID-19 shots don't create much IgA in the nose and lungs. So, people can still get infected or pass it on, even if they're vaccinated. But this study shows that nasal boosters can trigger strong, long-lasting immune protection where respiratory diseases like COVID-19 first attack.
"Understanding how this safe and simple nasal booster promotes protective mucosal immunity will make it easier to develop this approach for human use in the near future," Iwasaki said.
Iwasaki is also a professor of dermatology and of molecular, cellular, and developmental biology in Yale's Faculty of Arts and Sciences, a professor of epidemiology (microbial diseases) at Yale School of Public Health, and an investigator at the Howard Hughes Medical Institute.
Other Yale authors include Tianyang Mao, a former graduate student who is now a postdoctoral fellow at the Broad Institute of MIT and Harvard; Benjamin Israelow, assistant professor of medicine (infectious diseases) at YSM; Keyla Santos Guedes de Sá, a postdoctoral associate; and Huiping Dong, a research assistant.
More information: Dong-il Kwon et al, Mucosal unadjuvanted booster vaccines elicit local IgA responses by conversion of pre-existing immunity in mice, Nature Immunology (2025). DOI: 10.1038/s41590-025-02156-0
https://medicalxpress.com/news/2025-05-insights-safe-effective-nasal-vaccines.html
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