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Experts Question Efficacy of Popular Supplements Amidst High U.S. Consumption Rates

Experts Question Efficacy of Popular Supplements Amidst High U.S. Consumption Rates

A new survey indicates that nearly 80% of Americans regularly take dietary supplements, including vitamins, protein powders, and other products, with many believing these are crucial for their health. However, medical experts, such as Dr. Eric Topol, a cardiologist and founder of the Scripps Research Translational Institute, and Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School, express significant doubt regarding the proven benefits of most popular supplements. They suggest that while supplements can be beneficial for specific conditions like nutrient deficiencies or preventing birth defects, such cases represent a minority of users. For instance, clinical trials have largely failed to demonstrate the heart or brain health benefits often attributed to omega-3 supplements, and most individuals already consume sufficient protein through their diet, rendering protein supplements unnecessary.
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Grail rallies as FDA staff flags no major concerns for multi-cancer test

Grail rallies as FDA staff flags no major concerns for multi-cancer test

By Christy Santhosh and Padmanabhan Ananthan Sept 21 (Reuters) - The US FDA's staff reviewers did not raise major concerns about the accuracy and safety of Grail's blood test designed to detect more than 50 cancers, sending the company's shares soaring 35% on Monday.
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UC Berkeley Researchers Discover New Compound to Combat Obesity and Diabetes by Boosting Metabolism

UC Berkeley Researchers Discover New Compound to Combat Obesity and Diabetes by Boosting Metabolism

Researchers at UC Berkeley have identified a novel molecular compound, 5-tetradecyloxy-2-furoic acid (TOFA), that shows promise in treating obesity and diabetes by increasing the body's metabolic rate. Unlike existing GLP-1 medications such as Ozempic and Wegovy, which primarily suppress appetite, TOFA works by enhancing energy expenditure. The compound was found to both inhibit lipid production and activate genes responsible for burning fat and generating energy. In studies conducted on mice, TOFA improved insulin sensitivity, glucose control, and reduced triglycerides, leading to fat loss without significant reduction in lean muscle mass. This approach offers a different mechanism compared to current treatments, which often lead to side effects like nausea, gastrointestinal issues, and potential muscle loss due to appetite suppression. The research, published in Science Advances, highlights TOFA's ability to increase energy expenditure by up to 18% in mice without altering physical activity or body tempe...
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BriaCell Therapeutics Receives FDA Clearance for Prostate Cancer Clinical Trial, Advancing Off-the-Shelf Immunotherapy

BriaCell Therapeutics Receives FDA Clearance for Prostate Cancer Clinical Trial, Advancing Off-the-Shelf Immunotherapy

BriaCell Therapeutics Receives FDA Clearance for Prostate Cancer Clinical Trial, Advancing Off-the-Shelf Immunotherapy
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Sling Therapeutics Secures $123 Million for Thyroid Eye Disease Drug Trial

Sling Therapeutics Secures $123 Million for Thyroid Eye Disease Drug Trial

Sling Therapeutics Secures $123 Million for Thyroid Eye Disease Drug Trial
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Xenon Pharmaceuticals Halts Psychiatry Studies for Azetukalner Due to Psychosis Events

Xenon Pharmaceuticals Halts Psychiatry Studies for Azetukalner Due to Psychosis Events

Xenon Pharmaceuticals Halts Psychiatry Studies for Azetukalner Due to Psychosis Events
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MaaT Pharma Shifts Focus to U.S. Clinical Trial for MaaT013 Following Negative European Regulatory Opinion

MaaT Pharma Shifts Focus to U.S. Clinical Trial for MaaT013 Following Negative European Regulatory Opinion

MaaT Pharma, a clinical-stage biotechnology company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) maintained its negative opinion regarding the Conditional Marketing Authorization (CMA) application for MaaT013 (Xervyteg®). This decision, following a re-examination, concerns the treatment of acute Graft-versus-Host Disease (aGvHD) in adult patients with gastrointestinal involvement refractory to prior lines of therapy. The CHMP's view is that the available clinical data, based on a single-arm trial, does not sufficiently characterize the benefit-risk profile of MaaT013. Consequently, MaaT Pharma will now prioritize advancing its U.S. development plan for MaaT013, focusing on a randomized controlled Phase 3 trial named PHOENIX. Feedback from a Type C interaction with the Food and Drug Administration (FDA) supports the advancement of PHOENIX as a registrational Phase 3 trial, with potential first patient enrollment in the first half of 2027, c...
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Xenon Pharmaceuticals Halts Psychiatry Trials Due to Psychosis Events, Submits Epilepsy Drug for FDA Review

Xenon Pharmaceuticals Halts Psychiatry Trials Due to Psychosis Events, Submits Epilepsy Drug for FDA Review

Xenon Pharmaceuticals Halts Psychiatry Trials Due to Psychosis Events, Submits Epilepsy Drug for FDA Review
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FDA and SEC Enhance Information Sharing to Scrutinize Life Science Company Disclosures

FDA and SEC Enhance Information Sharing to Scrutinize Life Science Company Disclosures

The U.S. Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) have formalized a Memorandum of Understanding (MOU) to establish a cooperative framework for interagency information sharing. This agreement facilitates the exchange of non-public information between the two agencies. While the MOU does not introduce new disclosure obligations for public companies, it is expected to provide SEC staff with more ready access to non-public FDA information. This access will enable the SEC to evaluate whether disclosures made by FDA-regulated public companies were false or misleading. Specifically, the SEC may now compare public disclosures against FDA-facing records, including meeting minutes, regulatory correspondence, inspection reports, clinical trial data, safety reporting, and product reviews and approvals, during filing reviews, investigations, and enforcement actions. This streamlined process aims to expedite the SEC's access to information that was previously more cumberso...
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Eli Lilly Receives FDA Approval for Combination Breast Cancer Therapy

Eli Lilly Receives FDA Approval for Combination Breast Cancer Therapy

Eli Lilly's oral selective estrogen receptor degrader (SERD) imlunestrant (Inluriyo) has secured a second FDA approval, this time for use in combination with the CDK4/6 inhibitor abemaciclib (Verzenio), another drug from Lilly. This combination therapy is approved for ER-positive, HER2-negative breast cancer patients with ESR1 mutations whose disease has progressed after at least one line of endocrine therapy. The approval follows results from the phase 3 EMBER-3 trial, which demonstrated that the combination therapy doubled the median progression-free survival (PFS) to 11 months, compared to five and a half months for Inluriyo alone. According to Jacob Van Naarden, executive vice president and president of Lilly Oncology, this full approval expands the capabilities of Inluriyo in combination with Verzenio, offering a regimen with confirmed benefits that aligns with the clinical practice of changing therapy upon clinical progression. The all-oral combination targets two distinct drivers of tumor growth: on...
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Psychiatry Lags in Biomarker-Guided Treatment, ACNP Paper Proposes Roadmap for Precision Medicine

Psychiatry Lags in Biomarker-Guided Treatment, ACNP Paper Proposes Roadmap for Precision Medicine

A new position paper from the American College of Neuropsychopharmacology (ACNP), co-led by UCLA Health, highlights a significant gap in psychiatric treatment compared to other medical fields like cancer and Alzheimer's disease. Unlike these areas, psychiatric clinical trials predominantly rely on symptom checklists rather than objective biological signs (biomarkers) to enroll patients. This approach makes it difficult to identify specific patient subgroups and hinders the development of targeted treatments. The paper, published in NPP – Digital Psychiatry and Neuroscience, proposes a roadmap to integrate biomarkers into psychiatry, aiming to personalize treatment and improve outcomes. The authors, including university researchers, pharmaceutical industry representatives, and scientists from the National Institute of Mental Health and the FDA's Office of Neuroscience, suggest using measurable signals from blood, brain activity, or wearable devices to identify patient subgroups more precisely and design mor...
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FDA Clears Four Blood Tests for Alzheimer's Diagnosis, Clinical Trials Underway for Pre-Symptomatic Treatment

FDA Clears Four Blood Tests for Alzheimer's Diagnosis, Clinical Trials Underway for Pre-Symptomatic Treatment

The U.S. Food and Drug Administration (FDA) has cleared four blood tests designed to help doctors diagnose whether Alzheimer's disease is the cause of a patient's memory problems or other cognitive symptoms. These tests aim to differentiate Alzheimer's from other forms of dementia. While some laboratories and online services offer their own versions of these tests, dementia specialists caution against their use for individuals without symptoms, emphasizing that they are not yet approved or recommended for that population outside of research studies. Clinical trials are currently in progress to determine if existing Alzheimer's drugs could benefit individuals before they develop symptoms, which could potentially alter future testing recommendations. The tests measure specific protein markers, such as p-tau217, which are indicative of amyloid buildup in the brain, a hallmark of Alzheimer's disease. However, a positive test result indicates a risk factor, not a guarantee of developing the disease, as many old...