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Moderna Withdraws COVID-19/Influenza Combination Vaccine Application Following FDA Data Request

FDA Approval
  • Moderna voluntarily withdrew its biologics license application for mRNA-1083, a combination COVID-19/influenza vaccine for adults 50 and older, after the FDA requested additional phase 3 influenza efficacy data.
  • The company plans to resubmit the application later this year following completion of its ongoing phase 3 trial for the seasonal influenza vaccine mRNA-1010, with interim data expected this summer.
  • FDA approval is now targeted for 2026, representing a significant delay in bringing the first combination respiratory vaccine to market.
  • The withdrawal highlights the regulatory challenges facing combination vaccines and the FDA's heightened scrutiny of COVID-19 vaccine development under new leadership.

Texas A&M Researcher's Umbilical Cord Cell Therapy Shows Promise for ALS Treatment in Clinical Trials

NeurologyFDA Approval
  • Dr. Simrit Parmar at Texas A&M University has developed an innovative umbilical cord blood-derived T regulatory cell therapy that has demonstrated safety and efficacy in treating over 80 patients with ALS and other inflammatory diseases.
  • The therapy addresses inflammation using Treg cells that do not require donor-recipient matching and can be manufactured at scale from a single cord blood unit, with products remaining viable for up to three years when frozen.
  • Recent studies published in NEJM Evidence showed functional improvement in ALS patients following multiple infusions, while a historic partnership with Saudi Arabia's King Faisal Specialist Hospital will launch new clinical trials.
  • Dr. Parmar aims to secure FDA regulatory approval within two years for aplastic anemia treatment while seeking expanded funding for larger ALS patient studies in the United States.

FDA Approves Phraxis' EndoForce™ Connector, Advancing Hemodialysis Access Technology

FDA Approval
  • Phraxis Inc. has received FDA approval for EndoForce™ Connector, an innovative endovascular implant designed to simplify arteriovenous graft creation for hemodialysis patients.
  • The device demonstrated strong clinical performance in a pivotal multicenter study, achieving a 92% cumulative patency rate at six months and meeting all primary and secondary endpoints.
  • EndoForce™ eliminates the need for surgical venous dissection and promotes precise vessel-to-graft alignment, potentially reducing complications like intimal hyperplasia at the anastomosis site.

Indoco Remedies Receives FDA Approval for Generic Allopurinol Tablets to Treat High Uric Acid Levels

FDA Approval
  • Indoco Remedies has secured final US FDA approval for its Abbreviated New Drug Application (ANDA) for allopurinol tablets USP 200 mg, a generic equivalent to Casper Pharma's Zyloprim.
  • Allopurinol is primarily used to prevent or lower high uric acid levels in the blood, including excess levels caused by cancer medicines or in patients with kidney stones.
  • The approved generic will be manufactured at Indoco's Goa facility in India, strengthening the company's position in the US pharmaceutical market and supporting its global growth strategy.

FDA Approves Clinical Trial of Atia Vision's Innovative OmniVu Lens System for Cataract Patients

FDA Approval
  • 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

FDA Approval
  • 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.

The Hyalex Early Feasibility Study (EFS)

NCT06368700RecruitingNot Applicable
Hyalex Orthopaedics, Inc.
Posted 4/4/2024

FDA Approves First Blood Test for Alzheimer's Diagnosis, Boosting Roche and BioArctic Shares

FDA ApprovalNeurologyPrecision Medicine
• 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.

ATTR-CM Treatment Landscape Expands with Three FDA-Approved Disease-Modifying Therapies

Drug ApprovalFDA Approval
  • Transthyretin amyloid cardiomyopathy (ATTR-CM) has evolved from an untreatable condition to one managed with three FDA-approved disease-modifying agents: tafamidis, acoramidis, and vutrisiran.
  • Tafamidis demonstrated substantial survival benefit in the ATTR-ACT trial, while acoramidis showed similar efficacy in ATTRibute-CM, and vutrisiran represents a mechanistically distinct gene silencing approach validated in HELIOS-B.
  • Next-generation therapies targeting amyloid clearance from the myocardium are in development, including NI006, PRX004, and AT-02, potentially offering complementary treatment options.
  • The ACT-EARLY trial will test whether early treatment with acoramidis can prevent clinical disease onset in high-risk individuals with pathogenic TTR variants.

Izotropic Secures FDA Regulatory Alignment for IzoView Breast CT System, Advances Toward Pivotal Clinical Trial

FDA Approval
  • Izotropic Corporation has confirmed regulatory alignment with the FDA for its IzoView Breast CT Imaging System following a pre-submission meeting in March 2025, clearing the path for a pivotal U.S. clinical trial.
  • The company has completed a comprehensive 150-page strategic business plan and sophisticated financial modeling to support commercialization efforts and is actively seeking financing for clinical execution.
  • Izotropic has revised its exclusive global licensing agreement with UC Davis to align with current strategic positioning and regulatory timelines, requiring achievement of U.S. regulatory approval by specified dates.
  • The company is conducting targeted investor outreach with high-net-worth individuals and institutional stakeholders to fund the full scope of its planned U.S. clinical study and market entry strategy.

FDA Approves Sun Pharma's Next-Generation LED BLU-U Device for Actinic Keratosis Treatment

FDA Approval
  • 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.

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