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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.

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

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The U.S. Food and Drug Administration (FDA) has issued a direct final rule aimed at removing outdated references to animal testing in its drug and biologics regulations.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.

Wearables in Clinical Trials Face Integration and Standardization Challenges

Wearables in Clinical Trials Face Integration and Standardization Challenges

Wearable devices are increasingly being incorporated into clinical trials, often as part of broader digital product strategies rather than being fully integrated into the core clinical development strategy. This approach can lead to several issues, including the treatment of wearable data collection as optional, a lack of operational rigor, and insufficient attention to adherence compared to established clinical endpoints. Digital health teams, which often operate separately from clinical development teams, may struggle to demonstrate the clinical relevance of their solutions. This disconnect means that while wearables offer significant opportunities to extend the impact of therapeutic interventions, their full potential in generating robust longitudinal evidence for clinical decision-making is not being realized. The current dynamic often results in wearable-derived measurements being relegated to exploratory or supportive roles, rather than becoming primary or key secondary endpoints.

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

Compass Therapeutics to Proceed with FDA Application for Tovecimig Despite Agency's Recommendation for New Clinical Trial

Compass Therapeutics to Proceed with FDA Application for Tovecimig Despite Agency's Recommendation for New Clinical Trial

Compass Therapeutics to Proceed with FDA Application for Tovecimig Despite Agency's Recommendation for New Clinical Trial

RNA drug developer ADARx seeks $1.74 billion valuation in US IPO

RNA drug developer ADARx seeks $1.74 billion valuation in US IPO

Sept 21 (Reuters) - ADARx Pharmaceuticals is targeting a valuation of up to $1.74 billion in its US initial public offering, the company developing RNA drugs said on Monday. The ‌company is aiming to raise up to $371.9 million by offering 21.9 million shares priced between $15 and $17.

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-...

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 has announced positive preliminary efficacy results from its Phase II clinical study of lavengratinib (ABSK061), a selective orally available small-molecule FGFR2/3 inhibitor, for children with achondroplasia (ACH). In the initial and lowest dose cohort (0.064mg/kg QD), children aged 6 years and older with ACH who received lavengratinib for 27 weeks showed a mean increase of +2.4 cm/year in annualized height velocity (AHV) from baseline, achieving a 100% responder rate. The drug was well-tolerated, with no observed FGFR1 or FGFR2-associated adverse events. The ABSK061-202 study is a Phase II, multicenter, open-label, dose-escalation study evaluating the safety and efficacy of lavengratinib in children aged 3 to 12 years with ACH, with a planned treatment duration of 78 weeks. Preliminary safety evaluations for the first three dose cohorts have been successfully completed without identifying any safety concerns.

Recombinant Proteins Market Projected to Reach $14.6 Billion by 2034, Driven by Biologics Demand

Recombinant Proteins Market Projected to Reach $14.6 Billion by 2034, Driven by Biologics Demand

Recombinant Proteins Market Projected to Reach $14.6 Billion by 2034, Driven by Biologics Demand

FDA Approves Wegovy for Cardiovascular Risk Reduction in Overweight and Obese Patients

FDA Approves Wegovy for Cardiovascular Risk Reduction in Overweight and Obese Patients

In 2024, the U.S. Food and Drug Administration (FDA) approved Wegovy (semaglutide) to reduce the risk of cardiovascular death, myocardial infarction (heart attack), and stroke in specific overweight or obese patients who also have established cardiovascular disease. This approval is based on findings from the large-scale cardiovascular outcome study, SELECT, which demonstrated that Wegovy reduced the relative risk of major adverse cardiovascular events by approximately 20%. This marks a significant expansion of Wegovy's indications beyond its initial approval for weight management. The drug, originally known for its weight-loss efficacy, is now recognized for its broader benefits in patients with co-existing cardiovascular conditions. This development highlights a shift in the GLP-1 market, where competition is moving beyond just weight loss to include chronic disease indications.

Moderna's mRNA Flu Vaccine, mFlusiva, Now Available for Individuals 50 and Older in the U.S.

Moderna's mRNA Flu Vaccine, mFlusiva, Now Available for Individuals 50 and Older in the U.S.

Moderna has launched mFlusiva, the first messenger RNA (mRNA) flu vaccine in the United States, utilizing the same technology as the company's COVID-19 shots. This new vaccine is currently available only to individuals aged 50 and older. The Food and Drug Administration (FDA) granted traditional approval for adults 50 to 64 and accelerated approval for those 65 and older, with a requirement for Moderna to conduct an additional trial for the older age group. A late-stage clinical trial, published in the New England Journal of Medicine, indicated that mFlusiva was approximately 27% more effective than a standard flu shot in preventing laboratory-confirmed illness. The vaccine works by using a small genetic code snippet to train the body's immune system to recognize and combat the flu virus, with the mRNA then breaking down and not remaining in the body. While the Centers for Disease Control and Prevention (CDC) recommends vaccination by the end of October, they have not yet issued a formal recommendation for...