Clinical The Future of Clinical Studies: Trends and Innovations to Watch The Future of Clinical Studies: Trends and Innovations to Watch Clinical studies play a crucial role in advancing medical science and improving patient care. They provide the evidence-based data that allows clinicians to make informed decisions about treatments and therapies. As technology advances and the healthcare landscape evolves, several trends and innovations are shaping the […] Written by Admin October 24, 2023October 24, 2023 Saving Bookmark this article Bookmarked
Clinical Clinical Trial Finds Live Vaccinations Safe for Liver, Kidney Transplant Recipients CINCINNATI, Oct. 16, 2023. Live vaccinations provided to children who previously received liver or kidney transplants were found to be safe and prompted an immune response to guard against several life-threatening conditions, according to a new study published Oct. 12, 2023, in JAMA Network Open. The study, based on data from 18 organ transplant centers, […] Written by Admin October 23, 2023October 23, 2023 Saving Bookmark this article Bookmarked
Clinical Exploring the Ethical Considerations in Conducting Clinical Studies Exploring the Ethical Considerations in Conducting Clinical Studies Conducting clinical studies is an integral part of the medical research process. It allows researchers to investigate new treatments, interventions, and medications, ultimately leading to the advancement of medical knowledge. However, while clinical studies are crucial for medical progress, ethical considerations must be at the forefront of […] Written by Admin October 23, 2023October 23, 2023 Saving Bookmark this article Bookmarked
Clinical FDA Clears Application to Initiate Phase 1 Clinical Study of oral Immunotherapy for the Treatment of Rheumatoid Arthritis ROCKVILLE, Md., Oct. 19, 2023. – Rise Therapeutics, a biotechnology company engaged in developing novel oral immunotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a rheumatoid arthritis Phase 1 clinical trial for its program candidate, R-2487. This is Rise Therapeutics’ second […] Written by Admin October 22, 2023October 22, 2023 Saving Bookmark this article Bookmarked
Clinical Harnessing the Power of Clinical Trials for Health and Wellness Clinical trials play a crucial role in advancing health and wellness by harnessing the power of scientific research to develop innovative treatments, therapies, and preventive measures. These trials are carefully designed studies that evaluate the effectiveness and safety of new drugs, medical devices, diagnostic tools, or interventions. The primary goal of clinical trials is to […] Written by Admin October 22, 2023October 22, 2023 Saving Bookmark this article Bookmarked
Clinical Kisqali NATALEE analysis reinforces consistent reduction in risk of recurrence across key subgroups of patients with early breast cancer Basel, October 20, 2023. Novartis will present late-breaking results from a prespecified exploratory subgroup analysis of invasive disease-free survival (iDFS) from the pivotal Phase III NATALEE trial at the European Society for Medical Oncology (ESMO) Congress 2023. After 27.7 months of follow-up, the iDFS benefit with Kisqal (ribociclib) plus endocrine therapy (ET) was consistent across […] Written by Admin October 21, 2023October 21, 2023 Saving Bookmark this article Bookmarked
Clinical Navigating the Clinical Study Process: A Comprehensive Guide Navigating the Clinical Study Process: A Comprehensive Guide Clinical studies play a vital role in advancing medical research and innovation. These studies are designed to evaluate the safety and effectiveness of new drugs, medical devices, therapeutic interventions, and other treatments. For patients and healthcare professionals interested in participating or conducting clinical studies, it is essential […] Written by Admin October 21, 2023October 21, 2023 Saving Bookmark this article Bookmarked
Clinical FDA Grants Fast Track Designation to ANPD001, Autologous Investigational Cell Therapy for the Treatment of Parkinson’s Disease SAN DIEGO, Oct. 19, 2023 /PRNewswire/ — Aspen Neuroscience today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ANPD001 for the treatment of Parkinson’s disease (PD) to improve motor function. ANPD001, is a personalized (autologous) cell therapy under investigation to treat PD by replacing lost dopamine neurons. The […] Written by Admin October 20, 2023October 20, 2023 Saving Bookmark this article Bookmarked
Clinical The Impact of Clinical Research on Evidence-Based Medicine The Impact of Clinical Research on Evidence-Based Medicine Evidence-based medicine (EBM) has become an essential approach in healthcare, aiming to provide the highest quality of care through the integration of clinical expertise, patient values, and the best available research evidence. Clinical research, as a fundamental component of EBM, plays a critical role in shaping medical […] Written by Admin October 19, 2023October 19, 2023 Saving Bookmark this article Bookmarked
Clinical Takeda Announces Topline Results of Phase 3 ADMIRE-CD II Trial of Alofisel® (darvadstrocel) in Complex Crohn’s Perianal Fistulas OSAKA, Japan, October 18, 2023, and CAMBRIDGE, Massachusetts, October 17, 2023 — Takeda (TSE:4502/NYSE: TAK) today announced that the Phase 3 ADMIRE-CD II study, assessing the efficacy and safety of Alofisel® (darvadstrocel) for the treatment of complex Crohn’s Perianal Fistulas (CPF), did not meet its primary endpoint of combined remission at 24 weeks, based on […] Written by Admin October 19, 2023October 19, 2023 Saving Bookmark this article Bookmarked
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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