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
Mitochondrial presequences harbor variable strengths to maintain organellar function Hundreds of mitochondrial proteins rely on N-terminal presequences for organellar targeting and import. While generally described as positively charged amphiphilic helices, presequences lack a consensus motif and thus likely promote protein import into mitochondria with variable efficiencies. Indeed, the concept of presequence strength underlies biological models such as stress sensing, yet a quantitative analysis of […] Written by Admin January 9, 2026January 9, 2026 Saving Bookmark this article Bookmarked
Labour’s ‘deeply alarming’ attack on protest rights British authorities have severely restricted the right to protest in contravention of their international human rights obligations, creating an environment in which peaceful dissent is increasingly treated as a criminal act, Human Rights Watch said in its latest report. ‘Silencing the Streets’: The Right to Protest Under Attack in the UK documents that the UK’s […] Written by brendan January 9, 2026January 9, 2026 Saving Bookmark this article Bookmarked
Mitochondrial presequences harbor variable strengths to maintain organellar function Hundreds of mitochondrial proteins rely on N-terminal presequences for organellar targeting and import. While generally described as positively charged amphiphilic helices, presequences lack a consensus motif and thus likely promote protein import into mitochondria with variable efficiencies. Indeed, the concept of presequence strength underlies biological models such as stress sensing, yet a quantitative analysis of […] Written by Admin January 9, 2026January 9, 2026 Saving Bookmark this article Bookmarked
Labour’s ‘deeply alarming’ attack on protest rights British authorities have severely restricted the right to protest in contravention of their international human rights obligations, creating an environment in which peaceful dissent is increasingly treated as a criminal act, Human Rights Watch said in its latest report. ‘Silencing the Streets’: The Right to Protest Under Attack in the UK documents that the UK’s […] Written by brendan January 9, 2026January 9, 2026 Saving Bookmark this article Bookmarked
Ancient skeletons reveal viruses embedded in human DNA Scientists have, for the first time, rebuilt ancient genomes of Human betaherpesvirus 6A and 6B (HHV-6A/B) using DNA from archaeological human remains that are more than 2,000 years old. The research, led by teams at the University of Vienna and the University of Tartu (Estonia) and published in Science Advances, shows that these viruses have […] Written by Admin January 9, 2026January 9, 2026 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