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Bayer's Kerendia Receives Expanded FDA Approval for Type 1 Diabetes-Associated Chronic Kidney Disease

Bayer's Kerendia Receives Expanded FDA Approval for Type 1 Diabetes-Associated Chronic Kidney Disease

Bayer's Kerendia Receives Expanded FDA Approval for Type 1 Diabetes-Associated Chronic Kidney Disease
ReutersReuters
Experts urge FDA to set clear safety and access standards for psychedelic drugs (September 14)

Experts urge FDA to set clear safety and access standards for psychedelic drugs (September 14)

(Corrects quote attribution in paragraph 8 of September 14 story from Lynn Watkins, a U.S.
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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...
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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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Aptitude Receives FDA 510(k) Clearance for Next-Generation Metrix COVID Test

Aptitude Receives FDA 510(k) Clearance for Next-Generation Metrix COVID Test

Aptitude has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next-generation Metrix COVID Test. This marks the company's first FDA 510(k) clearance and signifies a continued expansion of the Metrix molecular diagnostics platform. The Metrix system is designed to make high-performance molecular testing more accessible, being small enough to be handheld and cleared for both over-the-counter and professional use in CLIA-waived settings. The updated COVID test offers substantial improvements over the original Emergency Use Authorization (EUA)-authorized product, providing approximately three-fold greater analytical sensitivity and 30% faster results. Development of this technology was supported by federal funds from the U.S. Department of Health and Human Services, specifically the Biomedical Advanced Research and Development Authority (BARDA).
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UNC Eshelman School of Pharmacy Researcher Develops Potential Chikungunya Treatments Amid Rising U.S. Cases

UNC Eshelman School of Pharmacy Researcher Develops Potential Chikungunya Treatments Amid Rising U.S. Cases

Anwar Hossain, a research assistant professor at the UNC Eshelman School of Pharmacy, is developing potential treatments for the mosquito-borne chikungunya virus. This initiative comes as the U.S. has reported over 100 travel-related cases of the virus this year. Hossain, a medicinal chemist, is advancing two promising compounds discovered through a federally funded center, part of the Rapidly Emerging Antiviral Drug Development Initiative (READDI) based at UNC-Chapel Hill. His work involves redesigning these compounds at a molecular level to enhance their potency against chikungunya and related viruses, with the ultimate goal of gaining Food and Drug Administration approval. The Translational Academy at Eshelman Innovation is supporting Hossain, providing funding and entrepreneurial training to help transition his lab discoveries into viable treatments. This support enabled his promotion from postdoctoral researcher and secured critical seed funds for his research.
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Morgan Stanley Conference Highlights Untapped GLP-1 Potential and AI's Role in Healthcare

Morgan Stanley Conference Highlights Untapped GLP-1 Potential and AI's Role in Healthcare

Morgan Stanley Conference Highlights Untapped GLP-1 Potential and AI's Role in Healthcare
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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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FDA Approves Moderna's mFLUSIVA, First mRNA Flu Vaccine for Adults 50 and Older

FDA Approves Moderna's mFLUSIVA, First mRNA Flu Vaccine for Adults 50 and Older

The U.S. Food and Drug Administration (FDA) has approved mFLUSIVA (mRNA-1010), Moderna's mRNA-based influenza vaccine, for adults aged 50 years and older. This marks the first mRNA flu vaccine to receive FDA approval. The approval for adults aged 50 through 64 years is traditional, while for those 65 and older, it was granted through an accelerated pathway, requiring further confirmatory evidence of clinical benefit. The pivotal FLUENT phase 3 trial, which involved over 40,000 adults aged 50 and above, demonstrated that mFLUSIVA had a 26.6% greater relative efficacy against confirmed influenza-like illness compared to a licensed standard-dose influenza vaccine. The mRNA technology instructs cells to train the immune system, and its manufacturing process does not require the propagation of vaccine viruses in eggs, potentially allowing for faster production closer to the flu season. Side effects reported for mFLUSIVA are similar to other vaccines, including mild reactions such as fatigue, muscle and joint ac...
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FDA Approves New Warnings for Kybella Injections Due to Adverse Reactions from Unapproved Use

FDA Approves New Warnings for Kybella Injections Due to Adverse Reactions from Unapproved Use

The U.S. Food and Drug Administration (FDA) has approved significant updates to the labeling for Kybella (deoxycholic acid) injection. These updates include new warnings regarding adverse reactions that can occur when the drug is used outside its approved indication, which is for submental fat (under the chin). The FDA now explicitly recommends against this unapproved use. This decision follows a comprehensive review of reports from the FDA Adverse Event Reporting System (FAERS) and medical literature, which revealed that administering Kybella outside the submental fat region can lead to serious neuromuscular and other adverse events. Additionally, the FDA has added language to the Warnings and Precautions section concerning the serious risks of injection site nodules (3 cm or smaller) and masses (larger than 3 cm). These nodules and masses may not resolve over time and could require medical intervention, occurring even when Kybella is used as indicated in the submental area, as well as in unapproved areas...
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Cell and Gene Therapy Industry Faces Scale-Up Challenges, Lifecycle Approach Proposed

Cell and Gene Therapy Industry Faces Scale-Up Challenges, Lifecycle Approach Proposed

Cell and Gene Therapy Industry Faces Scale-Up Challenges, Lifecycle Approach Proposed
ReutersReuters
US regulators to examine testosterone therapy as use by menopausal women rises

US regulators to examine testosterone therapy as use by menopausal women rises

By Siddhi Mahatole and Padmanabhan Ananthan Sept 17 (Reuters) - U.S. health regulators will review the scientific evidence on testosterone use in menopausal women on Thursday, including its benefits, risks, dosing and role in female health, as well as perspectives from doctors and patients.