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Palantir founder's plans for the FDA

Palantir founder's plans for the FDA

Politico3 days ago
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Joe Lonsdale, co-founder of the large government contractor Palantir, wants to embed a team of 15 to 20 'elite engineers' inside the Food and Drug Administration who would 'accelerate the FDA's latest AI initiatives,' according to a post he wrote on Substack.
The FDA recently announced that it has deployed an AI chatbot that will help staff speed up medical device and drug reviews.
Lonsdale is working with two organizations, the Abundance Institute, a year-old Utah-based nonprofit that hopes to accelerate the adoption of artificial intelligence, and Stand Together, a philanthropic organization founded by billionaire Charles Koch, to raise $4 million and train fellows who would be deployed at federal agencies.
'I'm sponsoring one of these AI-native engineers to help push this forward,' Lonsdale said on social media platform X.com.
But, but, but … How can billionaires just drop a team of engineers and product managers into a government agency? Through the Intergovernmental Personnel Act, a 1970 law that allows the government to forgo typical hiring practices to bring on experts from academia and nonprofits; those fellows 'can sit desk‑to‑desk with reviewers,' according to Lonsdale.
There's just one problem: 'This is not true,' said Andrew Nixon, spokesperson for the Department of Health and Human Services. The agency has no plans to take on fellows from Abundance Institute and Stand Together, he said.
Christopher Koopman, CEO of the Abundance Institute, told Future Pulse his organization has had discussions about bringing on its fellows with the FDA. And he said that in speaking with former FDA officials, he's under the impression that slow review times are a technical problem.
'They're problems of capability, not authority. That's what sparked the idea: What if we could forward-deploy high-impact, AI-native engineers into the agency, not as outside critics but as inside contributors, to help build modern systems and workflows that empower the FDA to do what it's already allowed to do, only better and faster?' he said.
Even so: The FDA has been hiring AI talent and rolled out an AI chatbot agencywide that Commissioner Marty Makary says will speed up review times. But agency staff have previously told POLITICO that the FDA's chatbot likely doesn't have the ability to do that. The challenges at the agency, they said, are more complicated than simply hiring more tech talent.
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EXAM ROOM
The National Institutes of Health will cap the amount that publishers of scientific journals can charge government-backed researchers to make their work publicly available starting in fiscal 2026, the agency said Tuesday.
'I am gravely concerned about the overall financial burden placed on the public — who may fund the original research, then pay again to access the resulting data, publications, or commercial products,' NIH Director Jay Bhattacharya said in a statement.
'In effect, taxpayers may bear multiple costs for innovations their contributions helped enable.'
By the numbers: According to the NIH, some major publishers charge upward of $13,000 per article for immediate open access. The charges are in addition to subscription fees that the government pays. High publishing costs are a double hit to taxpayers who already fund underlying NIH research, the statement said.
The NIH said one publisher receives $2 million in subscription fees from the agency and tens of millions in processing charges.
The move is the latest in a series of changes related to the distribution of NIH research under Bhattacharya, who's criticized the scientific publishing ecosystem for a lack of transparency and for favoring risk-averse studies.
In April, the agency moved up the timeline for making peer-reviewed NIH-funded research publicly available immediately without an embargo. The policy went into effect on July 1.
Big picture: Bhattacharya's boss, Health Secretary Robert F. Kennedy Jr., is not a fan of major scientific journals.
During a conversation on the 'Ultimate Human' podcast in May, Kennedy accused The New England Journal of Medicine, JAMA and The Lancet of being 'corrupt' and publishing studies funded and approved by pharmaceutical companies.
'Unless those journals change dramatically, we are going to stop NIH scientists from publishing in them, and we're going to create our own journals in-house,' Kennedy said.
At the time, a JAMA spokesperson said the journal had nothing to add when asked about Kennedy's remarks, while NEJM and The Lancet did not respond to requests for comment. HHS also did not respond to requests for comment.
Earlier this year, Bhattacharya and FDA Commissioner Marty Makary helped launch a publication, the Journal of the Academy of Public Health, to help promote open conversation among scientists. Both officials are on leave from the journal's editorial board.
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Amylyx Pharmaceuticals Presents New Exploratory Analyses from Phase 2 and Phase 2b Clinical Trials of Avexitide in Post-Bariatric Hypoglycemia at ENDO 2025
Amylyx Pharmaceuticals Presents New Exploratory Analyses from Phase 2 and Phase 2b Clinical Trials of Avexitide in Post-Bariatric Hypoglycemia at ENDO 2025

Associated Press

time42 minutes ago

  • Associated Press

Amylyx Pharmaceuticals Presents New Exploratory Analyses from Phase 2 and Phase 2b Clinical Trials of Avexitide in Post-Bariatric Hypoglycemia at ENDO 2025

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul 13, 2025-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) ('Amylyx' or the 'Company') today announced the presentation of new exploratory analyses from the Phase 2 PREVENT and Phase 2b clinical trials of avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist for the treatment of post-bariatric hypoglycemia (PBH) at the Endocrine Society's annual meeting (ENDO 2025). In the Phase 2b trial, avexitide 90 mg once daily, the dose being evaluated in the pivotal Phase 3 LUCIDITY trial, led to a 64% least-squares (LS) mean reduction (p=0.0031) vs. baseline in the composite rate of Level 2 and Level 3 hypoglycemic events in PBH, with more than half of the participants experiencing no events during the treatment period. LUCIDITY is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in approximately 75 participants with PBH following Roux-en-Y gastric bypass surgery. The FDA-agreed-upon primary endpoint of LUCIDITY is reduction in the composite of Level 2 and Level 3 hypoglycemic events. Consistent reductions in composite rate of Level 2 and Level 3 hypoglycemic events also were seen with avexitide 45 mg twice daily studied in the Phase 2b trial and avexitide 30 mg twice daily and 60 mg once daily studied in the Phase 2 PREVENT trial. New pharmacokinetic (PK) and pharmacodynamic (PD) data were also presented demonstrating continuous pharmacologic activity of the 90 mg once daily dose regimen for a 24-hour period. 'Post-bariatric hypoglycemia can profoundly disrupt daily life, requiring individuals to carefully manage meals, social interactions, and routines, often while living in fear of their next hypoglycemic event. The new analysis presented at ENDO 2025 continues to support that avexitide may significantly reduce the frequency of these events,' said Marilyn Tan, MD, FACE, Principal Investigator of the LUCIDITY trial and Clinical Associate Professor at Stanford University. Camille L. Bedrosian, MD, Chief Medical Officer of Amylyx, added, 'Post-bariatric hypoglycemia is a serious and underrecognized condition with no FDA-approved treatments. The data presented show that, in an exploratory analysis from the Phase 2 PREVENT and Phase 2b clinical trials, avexitide significantly reduced the composite rate of Level 2 and 3 hypoglycemic events, including at the 90 mg once daily dose that is being studied in our pivotal Phase 3 LUCIDITY trial. We are particularly encouraged that over half of participants did not experience Level 2 or Level 3 hypoglycemic events during the treatment period. In addition, the pharmacokinetic and pharmacodynamic data demonstrated continuous pharmacologic activity of avexitide 90 mg once daily dose over 24 hours. We continue to be encouraged by avexitide's potential to deliver consistent, meaningful benefit to people living with PBH.' The population PK and PD analyses presented at ENDO 2025 demonstrated that avexitide 90 mg once daily maintained consistent GLP-1 receptor inhibition from morning to midnight and between doses. In vitro potency studies showed an IC₅₀ of approximately 20-30 nM (70-100 ng/mL), indicating robust target inhibition even in the presence of significant levels of GLP-1. PK modeling demonstrated that avexitide plasma levels exceeded IC₅₀ for a full 24-hour period. LUCIDITY was informed by data from five PBH clinical trials of avexitide showing consistent, dose-dependent effects, including statistically significant and clinically meaningful reductions in hypoglycemic events. Avexitide was generally well-tolerated, with a favorable safety profile replicated across clinical trials. Completion of recruitment for LUCIDITY is expected in 2025, with a data readout anticipated in the first half of 2026 and, if approved, commercial launch anticipated in 2027. The presentation and posters are available on the ' Presentations ' tab of the Amylyx website. Webcast Information Amylyx will host an investor event today, July 13, 2025, at 6:00 p.m. PT / 9:00 p.m. ET in San Francisco to discuss post-bariatric hypoglycemia and avexitide. A live webcast of the presentation and Q&A portion of the event can be accessed under 'Events and Presentations' in the Investor section of the Company's website, The webcast will be archived and available for replay for 90 days following the event. 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The primary efficacy objective of LUCIDITY will evaluate the FDA-agreed upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Safety and tolerability will also be evaluated. About Amylyx Pharmaceuticals At Amylyx, our mission is to usher in a new era of treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are currently focused on three investigational therapies across several neurodegenerative and endocrine diseases in which we believe they can make the greatest impact. For more information, visit and follow us on LinkedIn and X. For investors, please visit Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Amylyx' expectations regarding: the potential of avexitide as a treatment for PBH; expectations regarding the timing for recruitment completion and topline data readout of the Phase 3 LUCIDITY trial of avexitide in PBH; and expectations regarding timing for potential commercialization of avexitide. Any forward-looking statements in this press release and related comments in the Company's earnings conference call are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx' program development activities; Amylyx' ability to execute on its regulatory development plans and expectations regarding the timing of results from its planned data announcements and initiation of clinical studies; the risk that early-stage results may not reflect later-stage results; Amylyx' ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx' operations, as well as the risks and uncertainties set forth in Amylyx' United States Securities and Exchange Commission (SEC) filings, including Amylyx' Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings with the SEC. 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NASA Continues Testing Multi-Billion Dollar Rocket While Trump Is Actively Trying to Cancel It
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DEA Crushes Illegal Marijuana - But Still Blocks MMJ's Legal Cannabis Drug for Huntington's
DEA Crushes Illegal Marijuana - But Still Blocks MMJ's Legal Cannabis Drug for Huntington's

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DEA Crushes Illegal Marijuana - But Still Blocks MMJ's Legal Cannabis Drug for Huntington's

While busting cartels, DEA continues war on science and suffering patients. Duane Boise, CEO of MMJ International Holdings, expressed frustration over the contrasting approaches of federal agencies, stating, 'While the FDA is facilitating medical innovation, the DEA's hindrance not only blocks scientific progress but also contradicts directives aimed at revitalizing domestic manufacturing.' This situation starkly contrasts with the 'Buy American' initiative endorsed by President Trump, which was intended to strengthen U.S. drug production capabilities and reduce dependence on foreign manufacturers. WASHINGTON, DC / ACCESS Newswire / July 13, 2025 / In a historic move, the Drug Enforcement Administration (DEA), alongside California officials, seized over $123 million in illegal cannabis in California's Central Valley. Touted as the largest cannabis eradication operation in state history, this multi-agency sweep destroyed 105,700 illegal plants and over 22,000 pounds of processed product-dealing a powerful blow to criminal diversion networks. But while the DEA proudly parades its enforcement success, it continues to obstruct a very different kind of cannabis operation-one backed by the FDA, supported by Congress, and desperately needed by patients. Why is the DEA targeting drug cartels, while simultaneously blocking science and medical progress? The DEA Operation: A Win Against Illicit Growers During the week of May 5, a coordinated task force involving the DEA, California National Guard, state and local law enforcement, and the Department of Fish and Wildlife executed dozens of warrants across Kern, Tulare, and Kings counties. Nine firearms were seized and multiple individuals arrested. 'This operation demonstrates the power of collaboration to dismantle criminal enterprises,' said California officials. But one form of cannabis remains untouched: federally compliant, FDA authorized medical cannabis research. DEA's Double Standard: Criminal Cartels Get Raided-Pharmaceutical Innovation Gets Sabotaged Despite this public victory, the DEA's track record tells a darker story: It targets illegal grows tainted with pesticides and mold But blocks companies like MMJ BioPharma Cultivation, which holds: Yet the agency continues to deny MMJ a bulk manufacturing license after nearly seven years of delay-citing retroactive 'Catch-22" policies and hiding behind a broken administrative law system. Obstructing Science While Crime Thrives While criminal operations flood state-legal markets with contaminated cannabis, the DEA has stood by, doing little to protect public health-until now. But even this long-overdue enforcement does not excuse the agency's refusal to act on federally authorized medical research. 'This isn't just negligence-it's sabotage,' said Duane Boise, CEO of MMJ BioPharma. 'We followed every federal rule, obtained FDA approvals, and proved our security protocols. The DEA's refusal to grant a license has delayed critical treatment for patients suffering from Huntington's Disease and Multiple Sclerosis.' A National Embarrassment MMJ BioPharma's situation has become a symbol of DEA dysfunction: Meanwhile, illicit grows flourish-and so does patient suffering. The Path Forward: Reform, Not Excuses With President Trump threatening 200% tariffs to bring pharmaceutical manufacturing back to U.S. soil, the DEA's outdated war on cannabis could derail America's pharmaceutical future before it starts. MMJ BioPharma calls for the following immediate actions: Remove DEA roadblocks to FDA-approved medical cannabis research Transfer cannabis pharmaceutical oversight to the FDA or NIH Investigate the DEA Diversion Control Division for systemic obstruction A Final Word: 'The DEA cannot be allowed to fight cartels with one hand and choke science with the other,' said Boise. 'Lives are on the line. We need enforcement-but we also need research progress.' MMJ is represented by attorney Megan Sheehan. CONTACT: Madison Hisey [email protected] 203-231-85832 SOURCE: MMJ International Holdings press release

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