Tagged News
USDA Approves First Autologous Immunotherapy for Canine Osteosarcoma
• ELIAS Cancer Immunotherapy (ECI) has received full approval from the USDA Center for Veterinary Biologics as the first autologous prescription product for treating canine osteosarcoma.
• The innovative treatment works by conditioning the dog's immune system to recognize cancer cells, then delivering activated killer T cells that target and attack those specific cancer cells.
• ECI is available at 100 authorized treatment centers across the United States, with the treatment process requiring cancer tissue collection prior to surgery for manufacturing the personalized therapy.
Ascelia Pharma Advances Orviglance NDA Following Positive FDA Meeting, Submission Planned for Mid-2025
• Ascelia Pharma has received positive guidance from the FDA regarding its New Drug Application for Orviglance, a novel contrast agent for MRI liver imaging in patients with impaired kidney function.
• The company's Phase 3 SPARKLE study met its primary endpoint with statistical significance (p<0.001), demonstrating Orviglance's ability to improve visualization of focal liver lesions in the target patient population.
• Following successful completion of nine clinical studies involving 286 participants, Ascelia plans to submit the Orviglance NDA by mid-2025, likely in early August, with a cash runway extending through at least the end of 2025.
Androgenetic Alopecia Pipeline Shows Promise with Over 100 Therapies in Development
• DelveInsight's latest report reveals a robust pipeline for androgenetic alopecia with 80+ companies developing 100+ therapeutic candidates across various clinical stages.
• Key emerging treatments include KX-826 from Kintor Pharma and Clascoterone from Cassiopea, which could significantly expand options beyond the current FDA-approved minoxidil and finasteride.
• Recent clinical trial results from companies like Veradermics, Chong Kun Dang, and Pelage Pharmaceuticals demonstrate increasing R&D investment in addressing this common condition affecting up to 50% of both men and women.
New Study Highlights Benefits of Maintaining High Factor VIII Levels in Hemophilia A Patients
• Maintaining high Factor VIII (FVIII) levels in people with hemophilia A provides significant clinical benefits, including reduced bleeding risk and better joint health preservation.
• Despite advances in prophylactic treatment, standard-of-care prophylaxis does not completely prevent joint damage or chronic pain, with approximately 47% of hemophilia patients experiencing ongoing pain.
• Recent innovations in hemophilia treatment, including extended half-life therapies, non-factor replacement options, and gene therapy, offer new approaches to sustaining higher FVIII levels and improving patient outcomes.
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Nuance Pharma's Ohtuvayre Receives First Approval Outside US for COPD Treatment in Macau
• Ohtuvayre (ensifentrine), a first-in-class dual PDE3/PDE4 inhibitor, has received regulatory approval in Macau SAR for maintenance treatment of COPD in adult patients.
• The novel therapy combines bronchodilator and non-steroidal anti-inflammatory effects in a single molecule, delivered via standard jet nebulizer without requiring complex breathing coordination.
• Following its US approval in June 2024, this marks the first international regulatory clearance for Ohtuvayre, with Nuance Pharma planning NDA submission in mainland China in 2025 after completing the ENHANCE-CHINA trial.
FDA Deputy Commissioner Signals Potential Reforms to PDUFA Program
• The FDA's deputy commissioner has indicated possible significant changes to the Prescription Drug User Fee Act (PDUFA) program, which funds FDA review activities through industry fees.
• Potential reforms may focus on streamlining the drug approval process, addressing regulatory bottlenecks, and enhancing transparency in FDA-industry interactions.
• These changes could impact pharmaceutical companies' product development timelines and strategies as the agency seeks to balance thorough safety reviews with efficient approval pathways.
Yuhan's Lung Cancer Drug Leclaza Secures European Approval in Combination Therapy
• Yuhan Corporation's third-generation EGFR-TKI lazertinib (Leclaza) has received European Commission approval in combination with J&J's Rybrevant for first-line treatment of EGFR-mutated non-small cell lung cancer.
• The Phase 3 MARIPOSA study demonstrated the combination therapy reduced disease progression risk by 30% compared to osimertinib, with median progression-free survival of 23.7 months versus 16.6 months.
• This milestone marks the first Korean anticancer drug approved in both the U.S. and Europe, triggering a $30 million payment to Yuhan as part of their $1.255 billion licensing deal with Johnson & Johnson.
DATROWAY® (Datopotamab Deruxtecan) Receives EU Approval for Previously Treated Metastatic HR+/HER2- Breast Cancer
• DATROWAY, a TROP2-directed antibody drug conjugate (ADC), has been approved in the European Union for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine therapy and at least one line of chemotherapy.
• The approval is based on the TROPION-Breast01 phase 3 trial, which showed DATROWAY reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median PFS of 6.9 months versus 4.9 months.
• This marks the second ADC approved for breast cancer based on Daiichi Sankyo's DXd technology and the third medicine from their oncology pipeline to receive EU approval, highlighting their commitment to developing innovative cancer treatments.
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Galderma's Phase III OLYMPIA 1 Trial Results Show Nemolizumab Significantly Improves Prurigo Nodularis Symptoms
• Newly published results in JAMA Dermatology demonstrate nemolizumab monotherapy significantly improved itch intensity and skin lesions in patients with moderate-to-severe prurigo nodularis compared to placebo.
• The OLYMPIA 1 trial showed rapid response as early as Week 4, with over six times more nemolizumab-treated patients achieving itch response and twenty times more reaching an itch-free or nearly itch-free state compared to placebo.
• Based on the OLYMPIA clinical trial program, nemolizumab (Nemluvio®) received FDA approval for adult prurigo nodularis in August 2024, with additional regulatory reviews ongoing worldwide.
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Roche's PiaSky Approved in EU as First Monthly Self-Administered Treatment for Paroxysmal Nocturnal Haemoglobinuria
• The European Commission has approved PiaSky (crovalimab), the first monthly subcutaneous treatment for paroxysmal nocturnal haemoglobinuria (PNH), offering patients the option to self-administer following training.
• PiaSky utilizes innovative recycling antibody technology developed by Chugai Pharmaceutical, allowing it to bind to C5 protein multiple times and remain effective longer with a small volume of medicine.
• Clinical trials demonstrated PiaSky's non-inferiority to eculizumab, the current standard of care, while potentially reducing treatment burden through less frequent administration and eliminating the need for regular clinic visits.
Related Clinical Trials:
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