Clinical Phase 2 Spring Trial Of LHP588, Treatment For P. Gingivalis-positive Alzheimer’s Disease Proceeds SAN FRANCISCO, Nov. 16, 2023. Lighthouse Pharmaceuticals, a clinical-stage biopharmaceutical company pioneering precision medicine for the treatment of Alzheimer’s and other diseases of aging, today announced clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for LHP588, the company’s next-generation gingipain inhibitor, for the treatment of P. gingivalis-positive […] Written by Admin November 17, 2023November 17, 2023 Saving Bookmark this article Bookmarked
Clinical Telitacicept Phase III Clinical Trial Results for Rheumatoid Arthritis Patients YANTAI, China, Nov. 15, 2023. RemeGen Co., Ltd. (“RemeGen” or “the Company”), a commercial-stage biotechnology company, is invited to present telitacicept Phase III Clinical Trial Results for Rheumatoid Arthritis Patients in a Late-Breaking Abstract Oral Presentation Session by the American College of Rheumatology(RA). According to the abstract, this Phase III, randomized, double-blind study evaluated the […] Written by Admin November 16, 2023November 16, 2023 Saving Bookmark this article Bookmarked
Clinical Wegovy (semaglutide) Injection 2.4 mg Cardiovascular Outcomes Data Presented at the American Heart Association Scientific Sessions and Simultaneously Published in the New England Journal of Medicine PLAINSBORO, N.J., November 11, 2023 – Novo Nordisk today announced the full results of SELECT, its landmark phase 3 cardiovascular outcomes trial investigating the effects of once-weekly Wegovy® (semaglutide) injection 2.4 mg in adults with established cardiovascular disease (CVD) and overweight or obesity but without diabetes, at the American Heart Association (AHA) annual Scientific Sessions […] Written by Admin November 15, 2023November 15, 2023 Saving Bookmark this article Bookmarked
Clinical Post Hoc Analysis Showed CIMZIA Resulted in Meaningful Efficacy for RA Patients with High Levels of Rheumatoid Factor (RF) ATLANTA, Nov. 11, 2023. CB, a global biopharmaceutical company, will present a post hoc analysis of the EXXELERATE trial examining the efficacy of CIMZIA (certolizumab pegol) and adalimumab in patients with rheumatoid arthritis (RA) with high rheumatoid factor (RF) levels. The data are being presented at the American College of Rheumatology (ACR) Convergence 2023 in […] Written by Admin November 14, 2023November 14, 2023 Saving Bookmark this article Bookmarked
Clinical Gilead and Arcus Announce New Data Showing Encouraging Clinical Activity of Anti-TIGIT Domvanalimab-Containing Regimen as First-line Treatment for Upper GI Cancers Preliminary data from Arm A1 of the Phase 2 EDGE-Gastric study showed promising ORR and six-month PFS results, irrespective of PD-L1 expression Domvanalimab is the only Fc-silent anti-TIGIT antibody in Phase 3 for upper GI adenocarcinomas and has the potential to be first to market for these cancers FOSTER CITY, Calif., & […] Written by Admin November 13, 2023November 13, 2023 Saving Bookmark this article Bookmarked
Clinical Phase 2 Nipocalimab Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis, Supporting its Progression into a Combination Study SPRING HOUSE, Pa., Nov. 7, 2023 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from the Phase 2a IRIS-RA clinical study for the treatment of adults living with moderate to severe active rheumatoid arthritis (RA) who have tested positive for anti-citrullinated protein antibodies (ACPAs)a and/or rheumatoid factor (RF), and who […] Written by Admin November 12, 2023November 12, 2023 Saving Bookmark this article Bookmarked
Clinical Takeda Announces Late-Breaking Data from Phase 2b Study of TAK-279, an Investigational, Oral, Once-Daily TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis OSAKA Japan and CAMBRIDGE, Massachusetts, November 7, 2023 – Takeda (TSE:4502/NYSE:TAK) today announced that the company will present positive results from its randomized, double-blind, placebo-controlled, Phase 2b trial evaluating TAK-279, an investigational oral allosteric tyrosine kinase 2 (TYK2) inhibitor with next generation selectivity, in patients with active psoriatic arthritis. These data (Abstract #L12) will be […] Written by Admin November 10, 2023November 10, 2023 Saving Bookmark this article Bookmarked
Clinical FDA Approves Zepbound for Chronic Weight Management, a New Treatment of Obesity or Overweight with Weight-Related Medical Problems INDIANAPOLIS, Nov. 8, 2023. The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s (NYSE: LLY) Zepbound™ (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. Zepbound is indicated for adults with obesity (with a BMI of 30 […] Written by Admin November 9, 2023November 9, 2023 Saving Bookmark this article Bookmarked
Clinical Amgen Presents New Data From Phase 2 Trial of Dazodalibep in Sjögren’s Syndrome THOUSAND OAKS, Calif., Nov. 7, 2023. Amgen (NASDAQ:AMGN) today announced new data from its Phase 2 study evaluating dazodalibep, an investigational medicine, for the treatment of Sjögren’s. These results will be featured in presentations at the American College of Rheumatology (ACR) Convergence 2023, Nov. 10-15, in San Diego. Findings from the study demonstrate that dazodalibep […] Written by Admin November 8, 2023November 8, 2023 Saving Bookmark this article Bookmarked
Clinical US Study Reveals CP-GEP’s Profound Impact on Stratifying Melanoma Patients for Long-Term Survival ROTTERDAM, Netherlands and SAN DIEGO, Nov. 6, 2023 . SkylineDx, an innovative molecular diagnostics company, is pleased to announce the forthcoming presentation of an impactful poster by Dr M.E. Egger at the upcoming Society for Melanoma Research Congress in Philadelphia. Dr. M.E. Egger’s presentation promises to usher in a new paradigm in disease staging and […] Written by Admin November 7, 2023November 7, 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