University of Virginia

University of Virginia Expands Manning Institute of Biotechnology with $66M Additional Contract

2 days ago

• Skanska has secured an additional $66 million contract with the University of Virginia to construct the Paul and Diane Manning Institute of Biotechnology, bringing advanced translational research capabilities to the Commonwealth. • The 354,000-square-foot facility will feature modular laboratories, expanded research spaces, and dedicated areas for up to 150 researchers and biotechnology companies to collaborate on cutting-edge science. • Construction of this first-of-its-kind research program in Virginia began in December 2023 and is scheduled for completion in the fourth quarter of 2027.

HIV Drugs Show Promising Potential to Reduce Alzheimer's Risk by Up to 13% Annually

14 days ago

• UVA Health researchers discovered that HIV medications called NRTIs significantly reduce Alzheimer's risk, with annual decreases of 6-13% observed across two major health insurance databases. • The protective effect appears specific to NRTIs, which block inflammasomes linked to Alzheimer's development, and could potentially prevent approximately 1 million new cases worldwide each year. • Researchers are now calling for clinical trials of both existing NRTIs and a newly developed inflammasome-blocking drug called K9, which they describe as a safer and more effective alternative.

FDA Approves Early Feasibility Study for Valcare Medical's AMEND Trans-Septal System for Mitral Regurgitation

2 months ago

• The FDA has granted Investigational Device Exemption approval for Valcare Medical's AMEND Trans-Septal System, allowing the company to commence an Early Feasibility Study for treating functional mitral regurgitation. • The study will enroll up to 15 subjects across seven U.S. investigational centers in the first half of 2025, evaluating the safety and functionality of this transcatheter device that mimics the surgical gold standard. • The AMEND system offers a minimally invasive alternative to open-heart surgery for patients with moderate-to-severe mitral regurgitation, with results from the First-in-Human Study to be presented at the upcoming CRT Conference.

Study Reveals ChatGPT Plus Outperforms Physician-AI Collaboration in Diagnostic Accuracy

4 months ago

• A randomized clinical trial across major academic medical centers found that physicians using ChatGPT Plus showed no significant improvement in diagnostic accuracy compared to those using traditional resources. • ChatGPT Plus demonstrated superior diagnostic capabilities when used independently, outperforming both physician groups, suggesting the need for better AI integration training in clinical settings. • Research led by UVA Health's Dr. Andrew Parsons indicates that healthcare organizations should focus on developing structured AI prompts and formal training programs for optimal clinical implementation.

MediBeacon's TGFR System Receives FDA Approval for Kidney Function Assessment

4 months ago

• The FDA has approved MediBeacon's Transdermal GFR (TGFR) system for assessing kidney function in adults with normal or impaired renal function. • The TGFR system includes a sensor, monitor, and Lumitrace injection, offering a non-invasive method without blood draws or urine analysis. • Clinical trials demonstrated the TGFR system met its primary efficacy endpoint, achieving a P30 value of 94% across diverse patient demographics. • The TGFR system offers a point-of-care solution, eliminating the need for complex laboratory analysis and providing rapid results.

NextBioMedical's Nexsphere-F Receives FDA IDE Approval for Knee Osteoarthritis Trial

4 months ago

• NextBioMedical's Nexsphere-F has received FDA IDE approval for a clinical trial (RESORB) to treat knee osteoarthritis via genicular artery embolization (GAE). • The RESORB trial is a multi-center, randomized, open-label study evaluating Nexsphere-F's efficacy in alleviating pain and improving mobility in OA patients. • Nexsphere-F, a fast-resorbable embolic microsphere, has already received CE-MDD approval and demonstrated safety and efficacy in musculoskeletal embolization in Asia and Europe. • The trial aims to address the limitations of current OA treatments by providing a sustainable, patient-friendly solution, potentially improving the quality of life for millions.

FDA Approves Brentuximab Vedotin Combination for Relapsed/Refractory Large B-Cell Lymphoma

4 months ago

• The FDA has approved brentuximab vedotin in combination with lenalidomide and rituximab for adult patients with relapsed or refractory LBCL. • The approval is specifically for those ineligible for auto-HSCT or CAR T-cell therapy after two or more lines of systemic therapy. • Data from the ECHELON-3 trial demonstrated a statistically significant improvement in overall survival with the brentuximab vedotin combination. • Common adverse events included neutropenia, thrombocytopenia, anemia, and peripheral neuropathy, manageable with dose modifications.

Research Explores Molecular Dynamics of CAR T Cells in Cancer Treatment

4 months ago

A recent study published in Science Advances provides new insights into the molecular dynamics of CAR T cells in cancer treatment, focusing on how different types of CAR T cells kill cancer cells. The research, conducted by a team from Baylor College of Medicine and other institutions, examines the immune synapse's role in enhancing CAR T cell efficacy against hard-to-treat malignancies.

Atai Life Sciences Bolsters Leadership Team to Advance Psychedelic Therapeutics Pipeline

4 months ago

• Atai Life Sciences appoints Srinivas Rao as sole CEO, promoting Kevin Craig to CMO and Glenn Short to CSO. • Gerd Kochendoerfer joins as COO to enhance strategic alignment and operational excellence for clinical programs. • The leadership changes support the advancement of VLS-01 and EMP-01 into Phase 2 trials for mental health disorders. • Atai anticipates Phase 2b data readout for Beckley Psytech's BPL-003, a key step for scalable psychedelic therapies.

Non-Hormonal Therapies Elinzanetant and Fezolinetant Offer New Hope for Menopause Management

5 months ago

• Elinzanetant, a dual neurokinin receptor antagonist, significantly reduced the frequency and severity of vasomotor symptoms (VMS) in clinical trials, with the FDA accepting its New Drug Application in October 2024. • Fezolinetant, the first-in-class NK3 receptor antagonist, has shown a 75-80% reduction in hot flash frequency and reduced severity, offering a non-hormonal option for women who cannot take hormones. • Both elinzanetant and fezolinetant target the brain's KNDy neurons, responsible for regulating body temperature, providing alternatives to SSRIs and other off-label treatments with fewer side effects. • While fezolinetant is associated with a low incidence of side effects like headaches and nausea, liver enzyme increases require monitoring, offering a targeted approach to managing VMS.

Cannabinoids Show Promise in Managing Peripheral Neuropathy Symptoms

5 months ago

• A systematic review of 14 clinical trials indicates that cannabis-based medicines may effectively treat peripheral neuropathy by reducing neuropathic pain. • The review, published in _The Journal of Hand Surgery_, found that 79% of studies reported improvements in neuropathic pain with cannabinoid treatments. • Secondary benefits, including enhanced sleep quality, reduced anxiety, and improved quality of life, were also observed in several studies with mild side effects. • Data suggests cannabis is used by chronic pain patients as an analgesic, often substituting opioids, highlighting its potential role in pain management.

Benfotiamine Enters Phase 2 Trial as Novel Alzheimer's Treatment

5 months ago

• A Phase 2A-2B clinical trial, Benfoteam, is underway to evaluate benfotiamine, a thiamine precursor, for slowing Alzheimer's progression in patients with mild cognitive impairment or mild dementia. • The trial, involving 406 participants across 50 sites, aims to determine the optimal safe dose of benfotiamine and its impact on global function and cognition over 18 months. • Benfotiamine targets thiamine deficiency, hypothesized to alter glucose metabolism in brain cells, potentially addressing the root cause of Alzheimer's disease, unlike current treatments focused on amyloid plaques. • Previous pilot studies showed promising results, with benfotiamine increasing blood thiamine levels and reducing cognitive decline, warranting further investigation into its efficacy.

FDA Grants Accelerated Approval to Tarlatamab for Previously Treated Extensive-Stage Small Cell Lung Cancer

6 months ago

• Tarlatamab (Imdelltra) receives accelerated FDA approval for extensive-stage small cell lung cancer (SCLC) post-platinum-based chemotherapy. • The approval was based on the DeLLphi-301 study, which demonstrated a 40% objective response rate among evaluable patients. • The median duration of response in the study was 9.7 months, with a significant proportion of responses lasting over 6 months. • Common adverse events included cytokine-release syndrome, fatigue, and pyrexia, necessitating careful monitoring and management.