Biotechnology Gourmey files first EU application for cell-based meat At the time of its EU market authorisation application, Gourmey SAS, which has raised €57.8m so far, has applied for authorisation from the competent authorities in the UK, Switzerland, Singapore and the USA. Ivo Rzegotta, responsible for political communication at GFI Europe interest group, described the application as an important signal for the sector: ‘Cultivated […] Written by Thomas Gabrielczyk July 29, 2024July 29, 2024 Saving Bookmark this article Bookmarked
Ionis Announces FDA Acceptance of New Drug Application for Donidalorsen for Prophylactic Treatment of HAE CARLSBAD, Calif., Nov. 4, 2024 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational… Written by Admin November 7, 2024November 7, 2024 Saving Bookmark this article Bookmarked
Activation of lysosomal Ca 2+ channels mitigates mitochondrial damage and oxidative stress Elevated levels of plasma-free fatty acids and oxidative stress have been identified as putative primary pathogenic factors in endothelial dysfunction etiology, though their roles are unclear. In human endothelial cells, we found that saturated fatty acids (SFAs)—including the plasma-predominant palmitic acid (PA)—cause mitochondrial fragmentation and elevation of intracellular reactive oxygen species (ROS) levels. TRPML1 is […] Written by Admin November 6, 2024November 6, 2024 Saving Bookmark this article Bookmarked
Ionis Announces FDA Acceptance of New Drug Application for Donidalorsen for Prophylactic Treatment of HAE CARLSBAD, Calif., Nov. 4, 2024 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational… Written by Admin November 7, 2024November 7, 2024 Saving Bookmark this article Bookmarked
Activation of lysosomal Ca 2+ channels mitigates mitochondrial damage and oxidative stress Elevated levels of plasma-free fatty acids and oxidative stress have been identified as putative primary pathogenic factors in endothelial dysfunction etiology, though their roles are unclear. In human endothelial cells, we found that saturated fatty acids (SFAs)—including the plasma-predominant palmitic acid (PA)—cause mitochondrial fragmentation and elevation of intracellular reactive oxygen species (ROS) levels. TRPML1 is […] Written by Admin November 6, 2024November 6, 2024 Saving Bookmark this article Bookmarked
Tuberculosis research in 2024: the latest advancements According to a new World Health Organization (WHO) report released on October 29, 2024, tuberculosis (TB) replaced COVID-19 to become the top cause of infectious disease-related deaths in 2023, as a total of 1.25 million people died from it last year. Additionally, 8.2 million people were newly diagnosed, up from 7.5 million in 2022. TB […] Written by Willow Shah-Neville November 6, 2024November 6, 2024 Saving Bookmark this article Bookmarked
Understanding PMDA Validation Rules v5.0 The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has always led the charge in ensuring the safety and efficacy of drug development. Their latest update, the PMDA Validation Rules version 5.0, which took effect on April 1, 2024, marks another significant step in this mission. Let’s break down what these new rules mean and […] Written by Admin July 10, 2024July 10, 2024 Saving Bookmark this article Bookmarked
Enhance Your SEND Submissions! Join PointCross on May 29th, 2024, at 12 PM EST / 9 AM PST for a must-attend webinar: The Most Common Issues in Preparing SEND. Ideal for professionals in data submission and regulatory compliance, this webinar offers valuable insights from our seasoned experts. Why Attend? Why PointCross? With over 10 years of experience and more […] Written by Admin May 23, 2024May 23, 2024 Saving Bookmark this article Bookmarked
