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Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment

Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment

Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment

Are GLP-1s causing blindness? What we know about rare cases

Are GLP-1s causing blindness? What we know about rare cases

GLP-1 makers Eli Lilly and Novo Nordisk have been the subject of thousands of lawsuits alleging injury. Those related to vision loss are the latest to pile up.

AI Becomes Essential in Biopharma for Accelerating Drug Development and R Pipelines

AI Becomes Essential in Biopharma for Accelerating Drug Development and R Pipelines

AI Becomes Essential in Biopharma for Accelerating Drug Development and R Pipelines

Novo CEO says pills could capture 50% of weight-loss market by 2030

Novo CEO says pills could capture 50% of weight-loss market by 2030

By Patrick Wingrove LONDON, Sept 22 - Weight-loss pills could capture as much as half of the global obesity drug market by 2030, Novo Nordisk's chief executive told Reuters on Tuesday, as the Danish drugmaker positions itself for a shift away from weekly injections.

MaaT Pharma Schedules Pre-IND Meeting with FDA for MaaT034 in Solid Tumors

MaaT Pharma Schedules Pre-IND Meeting with FDA for MaaT034 in Solid Tumors

MaaT Pharma, a clinical-stage biotechnology company, has scheduled a Pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for October 2026. This meeting will focus on Chemistry, Manufacturing, and Controls (CMC) for MaaT034, a novel Microbiome Ecosystem Therapy (MET-C) candidate. MaaT034 is designed to be evaluated in combination with PD-(L)1 inhibitors for advanced solid tumors, including second-line advanced non-small cell lung cancer (NSCLC) and refractory advanced melanoma. The company aims to initiate a First-in-Human study in late 2027, pending regulatory clearance and funding. MaaT034 is the first candidate from MaaT Pharma's MET-C platform, which utilizes artificial intelligence and co-culture technology to produce functionally selected microbial ecosystems.

Beacon Therapeutics Prepares FDA Filing for XLRP Gene Therapy After Positive Phase 3 Results

Beacon Therapeutics Prepares FDA Filing for XLRP Gene Therapy After Positive Phase 3 Results

Beacon Therapeutics is preparing to submit a rolling Biologics License Application (BLA) to the FDA later this year for its gene therapy, laruparetigene zovaparvovec (laru-zova), which treats X-linked retinitis pigmentosa (XLRP). This decision follows positive results from the pivotal Phase 2/3 VISTA trial, where laru-zova met its primary endpoint with statistical significance. The trial demonstrated a significant improvement in low luminance visual acuity (LLVA) responder rates at 12 months compared to an untreated control group. Specifically, 31% of XLRP patients receiving a high dose and 24.1% receiving a low dose achieved an improvement of 15 letters or more on an eye chart, with no responders in the control group. The gene therapy also exhibited a favorable safety and tolerability profile consistent with previous studies.

The antibiotic in your medicine cabinet? A doctor says
rethink it

The antibiotic in your medicine cabinet? A doctor says rethink it

A doctor explains why keeping leftover antibiotics is a risky habit and what you should do instead to protect your health and combat antibiotic resistance.

FDA Moves to Reduce Animal Testing Requirements for Drug Approval

FDA Moves to Reduce Animal Testing Requirements for Drug Approval

The U.S. Food and Drug Administration (FDA) has issued a direct final rule aimed at removing outdated references to animal testing in its drug and biologics regulations. This action is a significant step towards encouraging drug companies to utilize cutting-edge non-animal testing methods. Despite the FDA's public commitment to advancing non-animal test methods, existing regulations have often led companies to believe that animal testing is a mandatory requirement for drug approval. The new rule, which could become effective as early as February 4, 2027, directly responds to a 2024 legal petition filed by Humane World for Animals and Humane World Action Fund. These organizations advocated for the FDA to clarify that animal testing is not legally required. This initiative aligns with the FDA's stated goal of making animal tests "the exception rather than the norm" for preclinical safety and toxicity testing within the next three to five years.

FDA Implements New Rule to Accelerate Use of Non-Animal Testing Methods in Drug Development

FDA Implements New Rule to Accelerate Use of Non-Animal Testing Methods in Drug Development

The U.S. Food and Drug Administration (FDA) has issued a new rule to remove outdated animal-specific terminology from federal regulations, explicitly allowing modern, animal-free methods for generating safety information for new drugs and biological products. This move clarifies that nonclinical tests, including human cell-based systems, organs-on-chips, computer modeling, and organoids, are acceptable alternatives to traditional animal testing. This regulatory change follows the FDA Modernization Act 2.0, which was enacted in 2022 and championed by figures such as Sens. Rand Paul and Cory Booker, and Reps. Vern Buchanan and Buddy Carter. For over 80 years, federal law mandated preclinical tests, including animal testing, before new drugs could proceed to human clinical trials. The FDA Modernization Act 2.0 replaced this framework with a broader category of 'nonclinical tests,' recognizing various animal-free methods. The FDA's new rule aims to align regulations with this legislative change, providing more...

Arizona Republic

Could GLP‑1 drugs be causing blindness? Arizona lawsuits are growing

Could GLP‑1 drugs be causing blindness? Arizona lawsuits are growing

Arizonans trusted GLP-1 drugs to lose weight. Now, a growing number of lawsuits claim the medications may be linked to blindness.

President Trump Fast-Tracks Research and Access to Psychedelic Drugs for Mental Health

President Trump Fast-Tracks Research and Access to Psychedelic Drugs for Mental Health

President Trump has signed an executive order to accelerate research into and access to psychedelic drugs, including ibogaine compounds, as potential treatments for mental health conditions. This initiative includes a $50 million investment for state governments to study how psychedelics might aid individuals struggling with mental illnesses. The executive order also directs the FDA to provide national priority vouchers for certain psychedelic drugs, aiming to speed up the review process for approval. This move follows advocacy from high-profile supporters like podcast host Joe Rogan, who stated he provided information to President Trump that led to the swift decision. Ibogaine, a psychoactive compound from an African shrub, has shown early promise in altering neural pathways, potentially improving conditions such as PTSD, anxiety, and depression. Despite being classified as a Schedule I substance by the DEA, meaning it has no accepted medical use and a high potential for abuse, the FDA has a system to de-...

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.