Clinical Positive Results Announced in Largest Pivotal Phase 3 Trial of a First-in-Class Oral Antibiotic Zoliflodacin to Treat Uncomplicated Gonorrhea This is the first study to address a World Health Organization priority pathogen that has been sponsored and led by a non-profit organization. These positive preliminary findings offer hope for patients with this condition, particularly in the face of rising antibiotic resistance to current regimens. It also paves the way for a new […] Written by Admin November 6, 2023November 6, 2023 Saving Bookmark this article Bookmarked
Clinical Zibotentan/Dapagliflozin Combination Demonstrated Significant Albuminuria Reduction in Patients with Chronic Kidney Disease and Proteinuria in ZENITH-CKD Phase IIb Trial November 3, 2023 — Combination of zibotentan with dapagliflozin showed statistically significant and clinically meaningful reductions in urinary albumin-to-creatinine ratio (UACR), used to assess albuminuria, at 12 weeks compared with dapagliflozin alone. After 12 weeks of treatment, the Phase IIb ZENITH-CKD trial showed that the UACR difference of zibotentan/dapagliflozin versus dapagliflozin alone (n=177) was –33.7% […] Written by Admin November 5, 2023November 5, 2023 Saving Bookmark this article Bookmarked
Clinical REGENXBIO Presents Positive One Year Data from Phase II ALTITUDE Trial of ABBV-RGX-314 for Treatment of Diabetic Retinopathy ROCKVILLE, Md., Nov. 4, 2023. REGENXBIO Inc. today announced additional positive data from the ongoing Phase II ALTITUDE trial of ABBV-RGX-314 for the treatment of diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME) using in-office suprachoroidal delivery. The data will be presented at the American Academy of Ophthalmology meeting in San Francisco, CA by […] Written by Admin November 4, 2023November 4, 2023 Saving Bookmark this article Bookmarked
Clinical Daré Bioscience Announces Additional Positive Data from Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women and Proposed Endpoints and Patient Population for Phase 3 Program Additional Analyses of Phase 2b Data Conducted in Population of Study Participants with Female Sexual Interest/Arousal Disorder (FSIAD), With Primary Complaint of Arousal Dysfunction Achieved Statistical Significance and Clinically Meaningful Improvement in Phase 2b Co-Primary Endpoint Assessing Arousal Sensation, and Statistical Significance in Items from Phase 2b Co-Primary Endpoint Scale Evaluating Concern Related […] Written by Admin November 3, 2023November 3, 2023 Saving Bookmark this article Bookmarked
Clinical NIH Researchers Develop Approach That Could Help Supercharge T-Cell Therapies Against Solid Tumors November 1, 2023 — Researchers at the National Institutes of Health have developed a way to potentially increase the effectiveness of T cell–based immunotherapy treatments, such as CAR T-cell therapy, against solid tumors. T cells are specialized white blood cells of the immune system that eliminate infected or abnormal cells. In animal studies, the enhanced […] Written by Admin November 2, 2023November 2, 2023 Saving Bookmark this article Bookmarked
Clinical Positive Top-Line Results from Real-World Study in China Evaluating the Safety and Efficacy of DEXTENZA in Patients after Cataract Surgery SHANGHAI, Oct. 31, 2023. AffaMed Therapeutics (“AffaMed”), a global biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders, announced positive top-line results from the Real-World Study conducted in the Boao Lecheng Pilot Zone in Hainan, China, to evaluate the […] Written by Admin November 1, 2023November 1, 2023 Saving Bookmark this article Bookmarked
Clinical First Person With Cystic Fibrosis Dosed In Phase 1 Trial Of Investigational Therapy Cm001, Designed To Form Ion Channels To Help Restore Airway Function CHAMPAIGN, Ill., Oct. 30, 2023. cystetic Medicines, Inc., a clinical-stage biotechnology company developing small molecule channels that serve as molecular prosthetics for missing or dysfunctional CFTR protein channels, announced today it has dosed the first person with cystic fibrosis (CF) as part of an ongoing Phase 1 clinical trial (NCT05802264) of its investigational inhalable small […] Written by Admin October 31, 2023October 31, 2023 Saving Bookmark this article Bookmarked
Clinical Robust Weight Loss Efficacy, Multiple Metabolic Ben6fits and Favorable Safety Profile of Higher Dose 9 mg Mazdutide Phase 2 Study for Obesity ROCKVILLE, Md. and SUZHOU, China, Oct. 29, 2023. Innovent Biologics, Inc. (Innovent), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, today announced the 48-week treatment results of the Phase 2 clinical study (ClinicalTrials.gov, NCT04904913) of higher dose (9 mg) mazdutide […] Written by Admin October 30, 2023October 30, 2023 Saving Bookmark this article Bookmarked
Clinical Make Money While Making a Difference: Participating in Paid Clinical Studies Clinical studies play a crucial role in the development of new drugs, medical procedures, and treatment options. They are essential to ensure the safety and efficacy of healthcare interventions before they are made available to the general public. While many people are willing to contribute to medical advancements, not everyone is aware that participating in […] Written by Admin October 30, 2023October 30, 2023 Saving Bookmark this article Bookmarked
Clinical Bristol Myers Squibb Announces U.S. FDA Breakthrough Therapy Designation for Investigational LPA1 Antagonist for Progressive Pulmonary Fibrosis PRINCETON, N.J. Oct 24, 2023 — Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist, for the treatment of progressive pulmonary fibrosis (PPF), a devastating, life-threatening illness. Currently, there is only one […] Written by Admin October 29, 2023October 29, 2023 Saving Bookmark this article Bookmarked
Researchers outline new approach for better understanding animal consciousness A team of researchers has outlined a new approach for better understanding the depths of animal consciousness, a method that may yield new insights into the similarities and differences among living organisms. The essay, which appears in the journal Science, describes a “marker method” that scientists can use to assess animal consciousness. It involves identifying […] Written by Admin February 21, 2025February 21, 2025 Saving Bookmark this article Bookmarked
Unveiling the Elasticity Secrets of Flexible Crystals Australian researchers have achieved significant breakthroughs in understanding the intrinsic properties of flexible crystalline materials, paving the way for potential advancements in the fields of building materials, electronics, and various technologies. The research team, which includes experts from The University of Queensland (UQ) and Queensland University of Technology (QUT), focused their investigation on the elastic […] Written by Bioengineer February 21, 2025February 21, 2025 Saving Bookmark this article Bookmarked
Researchers outline new approach for better understanding animal consciousness A team of researchers has outlined a new approach for better understanding the depths of animal consciousness, a method that may yield new insights into the similarities and differences among living organisms. The essay, which appears in the journal Science, describes a “marker method” that scientists can use to assess animal consciousness. It involves identifying […] Written by Admin February 21, 2025February 21, 2025 Saving Bookmark this article Bookmarked
Unveiling the Elasticity Secrets of Flexible Crystals Australian researchers have achieved significant breakthroughs in understanding the intrinsic properties of flexible crystalline materials, paving the way for potential advancements in the fields of building materials, electronics, and various technologies. The research team, which includes experts from The University of Queensland (UQ) and Queensland University of Technology (QUT), focused their investigation on the elastic […] Written by Bioengineer February 21, 2025February 21, 2025 Saving Bookmark this article Bookmarked
Urban environments promote adaptation to multiple stressors Animal populations from urban areas show significantly higher resilience to stressful environmental conditions. This was found by an international team of researchers led by Dr Elizabeta Briski from the GEOMAR Helmholtz Centre for Ocean Research Kiel, Germany. The mussel and crustacean species studied were able to adapt to disturbed environments, making them more resistant to […] Written by Admin February 20, 2025February 20, 2025 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