Tagged News
FDA Approves Clinical Trial of Atia Vision's Innovative OmniVu Lens System for Cataract Patients
• Atia Vision has received FDA Investigational Device Exemption approval to begin a traditional feasibility clinical trial of its OmniVu Lens System in cataract surgery patients.
• The OmniVu system features a unique dual-component design with a fluid-filled shape-changing base and front optic, engineered to restore dynamic range of vision from near to distance.
• International trials have shown promising results with 100% of patients achieving 20/20 or better uncorrected distance vision and preliminary data suggesting visual quality comparable to monofocal lenses.
FDA Approves Hyalex Orthopaedics' IDE Supplement for Pivotal Trial of Freestyle Knee Implant
• The FDA has approved Hyalex Orthopaedics' supplemental IDE application, allowing expansion of their Early Feasibility Study into a pivotal clinical trial for the Freestyle Knee Implant.
• The novel implant technology targets patients with cartilage damage and early osteoarthritis of the femoral condyle, addressing an estimated $2 billion market in the US with limited current treatment options.
• Early clinical evaluations have shown promising results in mimicking natural joint mechanics and helping patients return to active lifestyles, according to principal investigator Dr. Sabrina Strickland.
Related Clinical Trials:
Hyalex Orthopaedics, Inc.
Posted 4/4/2024
FDA Approves First Blood Test for Alzheimer's Diagnosis, Boosting Roche and BioArctic Shares
• The U.S. Food and Drug Administration has approved the first blood test for diagnosing Alzheimer's disease, potentially revolutionizing patient identification and treatment pathways.
• The diagnostic breakthrough is expected to drive market activity for pharmaceutical companies Roche and BioArctic, whose shares showed positive movement following the regulatory announcement.
• This blood test could significantly streamline the Alzheimer's diagnostic process, making it more accessible and efficient compared to traditional methods that rely on expensive brain scans and invasive procedures.
FDA Approves Sun Pharma's Next-Generation LED BLU-U Device for Actinic Keratosis Treatment
• The FDA has granted premarket approval for Sun Pharma's next-generation BLU-U Blue Light Photodynamic Therapy Illuminator, featuring LED panels instead of fluorescent tubes for treating actinic keratosis.
• The new LED BLU-U maintains the same safety and efficacy profile while offering a more compact design with a five-panel shape, improved LED arrangement, and enhanced functionality for better patient comfort.
• Approved under FDA's Real-Time Review Program, the device works in combination with LEVULAN KERASTICK topical solution to effectively target and clear actinic keratoses on the face, scalp, and upper extremities.
Lupin Receives FDA Approval for Generic Rivaroxaban Tablets for Thrombosis Prevention
• Lupin has received U.S. FDA approval for its generic version of Rivaroxaban Tablets, expanding its cardiovascular portfolio with a key anticoagulant medication.
• Rivaroxaban is primarily indicated for the prevention and treatment of deep vein thrombosis, pulmonary embolism, and stroke prevention in patients with atrial fibrillation.
• The approval represents a significant milestone for Lupin in the competitive generic pharmaceutical market, potentially offering a more affordable alternative to Janssen's branded Xarelto.
FDA-Approved Lenire Device Shows 91.5% Success Rate in Real-World Tinnitus Treatment Study
• A new study published in Nature Communications Medicine reveals that 91.5% of tinnitus patients experienced clinically meaningful improvement after 12 weeks of treatment with the Lenire bimodal neuromodulation device.
• The retrospective analysis of 220 patients represents one of the largest real-world studies of tinnitus treatment, confirming results from previous clinical trials that led to FDA approval in March 2023.
• Lenire works by simultaneously delivering audio tones through headphones and mild electrical pulses to the tongue, offering a promising treatment option for the estimated 25 million Americans suffering from tinnitus.
FDA Approves Theratechnologies' EGRIFTA SV Prior Approval Supplement and Alpha Tau's Trial for Recurrent Glioblastoma
• Theratechnologies has received FDA approval for a Prior Approval Supplement (PAS) for EGRIFTA SV, paving the way for its replacement with the new EGRIFTA WR formulation while ensuring continued distribution of EGRIFTA SV.
• Alpha Tau has secured FDA approval to initiate a clinical trial evaluating its Alpha DaRT technology for patients with recurrent glioblastoma, representing a potential new treatment approach for this aggressive brain cancer.
• Both regulatory milestones highlight ongoing innovation in specialized therapeutic areas, with Theratechnologies focusing on metabolic conditions and Alpha Tau advancing novel radiation technology for difficult-to-treat cancers.
FDA Approves Tevimbra-Chemotherapy Combination for First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma
• The FDA has approved BeiGene's Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.
• In the pivotal RATIONALE-306 trial, patients treated with Tevimbra plus chemotherapy demonstrated a median overall survival of 16.8 months compared to 9.6 months with chemotherapy alone, representing a 34% reduction in risk of death.
• This marks BeiGene's third FDA approval in less than a year, following previous approvals for Tevimbra in second-line ESCC and first-line gastric/gastroesophageal junction cancers, highlighting the company's expanding oncology portfolio.
Related Clinical Trials:
BeiGene
Posted 1/26/2018
BeiGene
Posted 7/22/2019
FDA Approves Merck's CAPVAXIVE: First 21-Serotype Pneumococcal Vaccine Designed Specifically for Adults
• The FDA has approved Merck's CAPVAXIVE, a novel 21-valent pneumococcal conjugate vaccine specifically designed to protect adults against serotypes causing the majority of invasive pneumococcal disease.
• CAPVAXIVE includes eight unique serotypes not covered by other approved pneumococcal vaccines, targeting approximately 84% of invasive pneumococcal disease cases in adults over 50, compared to 52% covered by PCV20.
• The single-dose vaccine demonstrated robust immunogenicity across various adult populations, with the CDC's Advisory Committee on Immunization Practices expected to make recommendations for its use later this month.
Related Clinical Trials:
Merck Sharp & Dohme LLC
Posted 7/12/2022
Merck Sharp & Dohme LLC
Posted 9/23/2022
Merck Sharp & Dohme LLC
Posted 7/13/2022