RUTGERS UNIVERSITY

FDA Fast-Tracks NeuroVive's Traumatic Brain Injury Drug

4 months ago

The FDA has granted Fast Track designation to NeuroVive's drug, NeuroSTAT, aimed at treating moderate to severe traumatic brain injury (TBI). This status accelerates the drug's development and review process, offering more frequent FDA interactions and feedback. NeuroSTAT works by protecting mitochondria, aiming to prevent secondary brain damage post-TBI, with hopes of improving survival, quality of life, and neurological function. Early trials have shown promising results, including a 35% decrease in brain injury volume in experimental models.

Liberal Blood Transfusion Post-Heart Attack Reduces Mortality in Anemic Patients

5 months ago

• A new study suggests that a more liberal blood transfusion strategy in anemic patients following a heart attack may reduce the risk of death at six months. • The research, analyzing data from multiple clinical trials, indicates a potential survival benefit with increased blood transfusions in this specific patient population. • While not definitively proving causality, the findings support the idea that optimizing oxygen delivery via transfusion could improve outcomes for anemic heart attack patients. • The study emphasizes the importance of individualized treatment approaches, considering patient-specific factors in transfusion decisions.

Humacyte's Bioengineered Vessel SYMVESS Receives FDA Approval for Extremity Vascular Trauma

5 months ago

• The FDA has approved SYMVESS, Humacyte's acellular tissue-engineered vessel, for treating extremity arterial injuries in adults when urgent revascularization is needed. • SYMVESS offers a readily available alternative to autologous vein grafts, reducing surgical time and avoiding additional incisions in already-injured patients. • Clinical trials showed high patency rates and low rates of amputation and infection, positioning SYMVESS as a promising option for vascular trauma care. • SYMVESS has received Regenerative Medicine Advanced Therapy designation and priority review, highlighting its potential to address a significant unmet medical need.

Tharimmune's TH104 Advances to Phase 2 for Pruritus in Primary Biliary Cholangitis

5 months ago

• Tharimmune plans to initiate a Phase 2 clinical trial in 2025 to evaluate TH104 for moderate-to-severe pruritus associated with primary biliary cholangitis (PBC). • The Phase 2 trial will be a multicenter, randomized, double-blind, placebo-controlled study enrolling approximately 40 patients across the U.S., Europe, and the UK. • TH104 demonstrated a favorable pharmacokinetic profile and a mild side-effect profile in a Phase 1 clinical trial, with positive regulatory feedback from the FDA and EMA. • The company also reported corporate achievements, including licensing agreements and the appointment of Sanam Parikh to its Board of Directors.

FDA Approves Orlynvah, a New Oral Penem Antibiotic, for Uncomplicated UTIs

5 months ago

• The FDA has approved Orlynvah (sulopenem etzadroxil and probenecid) as the first oral penem antibiotic for uncomplicated urinary tract infections (uUTIs). • Orlynvah is indicated for adult women with uUTIs caused by specific bacteria, including Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, when other oral options are limited. • Clinical trials demonstrated Orlynvah's superiority over ciprofloxacin in fluoroquinolone-resistant infections and statistical superiority to Augmentin in Augmentin-susceptible cases. • Orlynvah offers a new treatment option to combat antimicrobial resistance, particularly in quinolone-resistant organisms and ESBL-producing E. coli, potentially reducing hospitalizations.

Cabaletta Bio Announces Positive Clinical Updates for CABA-201 in Autoimmune Diseases

6 months ago

• Cabaletta Bio reported clinical data from RESET-Myositis™, RESET-SLE™, and initial data from RESET-SSc™ trials at ACR Convergence 2024, showcasing CABA-201's potential in autoimmune disease treatment. • Sixteen patients have been enrolled, with ten dosed across the RESET™ clinical development program, and 40 U.S. clinical sites are actively recruiting patients for CABA-201 trials. • Cabaletta anticipates a meeting with the FDA in 2025 to discuss potential registrational program designs for CABA-201, pending data outcomes. • EMA has authorized clinical trials for CABA-201 in Europe for lupus, expanding the clinical development program internationally.

STRIPE Initiative Advances Pharmacogenetic Testing Standards with Focus on DPYD-Guided Chemotherapy

7 months ago

• Leading experts at the STRIPE Annual Meeting addressed the need for unified guidelines across FDA, EMA, CPIC, and NCCN for DPYD genotype-guided chemotherapy dosing in cancer treatments. • The innovative MetaCensus platform was introduced as a collaborative tool for evidence sharing and consensus building in pharmacogenetic testing, promoting transparent evaluation processes. • Pharmacists are playing a crucial role in advancing pharmacogenomics through clinical consultations and research, while emphasizing the importance of multi-disciplinary collaboration in precision medicine implementation.

Dazdotuftide Eye Drops Show Promise in Non-Infectious Uveitis Treatment

7 months ago

• Dazdotuftide (TRS01) eye drops demonstrate a favorable safety profile, suggesting potential as a first-line treatment for non-infectious anterior uveitis. • In a Phase 3 trial, TRS01 showed non-inferiority to prednisolone in reducing ocular pain and anterior chamber flare, with fewer IOP elevation risks. • A subset of uveitic glaucoma patients treated with TRS01 experienced resolution of inflammation and stable intraocular pressure, indicating potential benefits. • TRS01's unique mechanism of action targets ocular blinding diseases, offering a steroid-free alternative to manage inflammation without steroid-related side effects.

Horsemanship Program Eases PTSD Symptoms in Combat Veterans

8 months ago

• A recent study reveals that combat veterans participating in an eight-week horsemanship program experienced a reduction in PTSD symptoms and improved mental well-being. • The program involved veterans learning basic horse safety and behavior, grooming horses, and leading them, promoting present-moment focus and reducing hypervigilance. • Researchers observed decreased stress hormone concentrations in veterans and preliminary evidence of co-regulation between veterans and horses. • Alternative therapies like horsemanship are valuable due to high dropout rates from traditional PTSD treatments among military veterans.