FDA Accepts Review of Lerodalcibep for LDL Cholesterol Reduction
The FDA has accepted the regulatory application for lerodalcibep, a novel therapeutic candidate aimed at reducing LDL cholesterol levels in patients with hypercholesterolemia.
NeoGenomics Expands Northeast Presence with Strategic Acquisition of Pathline
NeoGenomics has completed its acquisition of Pathline, LLC, a CLIA/CAP/NYS-certified laboratory based in New Jersey, strengthening its commercial footprint in the historically underpenetrated Northeast market.
Revolutionizing Drug Development: The Rise of Targeted Protein Degradation
Targeted Protein Degradation (TPD) represents a groundbreaking shift in pharmaceutical research, offering a novel approach to drug development by leveraging the body's natural protein degradation system. This method, which involves tagging disease-causing proteins for destruction by the proteasome, has shown promising results in clinical trials, particularly in cancer treatment. With over 36 drugs currently in clinical testing, TPD is paving the way for treatments that were previously unattainable, marking a significant advancement in the fight against complex diseases.
Metagenomic Sequencing Test Offers Rapid Diagnosis of Neurological Infections
A novel metagenomic sequencing (mNGS) test rapidly diagnoses rare and common neurological infections by identifying pathogens in cerebrospinal fluid.
Bayer Halts Development of Eliapixant Due to Safety Concerns
Bayer has discontinued the development of eliapixant, a P2X3 receptor antagonist, citing safety concerns despite promising clinical trial results. This decision follows the FDA's rejection of Merck & Co's similar drug, gefapixant, for the same reasons.
Revolutionizing Cancer Treatment: The Rise of Functional Precision Medicine
A groundbreaking approach to cancer treatment, combining genetic testing with ex-vivo drug screening, is showing promising results in clinical trials. Led by Diana Azzam at FIU, this method aims to find the most effective drugs for individual patients, significantly improving outcomes for those with hard-to-treat cancers.
Breakthroughs in Clinical Trials: A Week of Promising Developments
This week's clinical trials round-up highlights significant advancements in treatments for various conditions, including idiopathic pulmonary fibrosis, diabetes, COPD, and advanced solid tumours. Key developments include positive Phase 2 results for Faron Pharmaceuticals' BEXMAB trial, AstraZeneca's Phase 2a COURSE trial for COPD, and Johnson & Johnson's Phase 3 QUASAR maintenance study for ulcerative colitis.
New Genetic Findings Challenge Traditional Understanding of Coats' Disease
Research led by Dr. David Abramson reveals that Coats' disease, traditionally considered unilateral, shows bilateral involvement when examined with fluorescein angiography, challenging long-held clinical beliefs.
FDA Proposes Removal of Oral Phenylephrine as Ineffective Decongestant
The FDA has proposed removing oral phenylephrine from the list of approved over-the-counter decongestants due to its lack of efficacy in relieving nasal congestion.
Health Canada Approves Expansion of Decoy20 Cancer Immunotherapy Trial
Indaptus Therapeutics receives Clinical Trial Authorization from Health Canada to expand its ongoing U.S. clinical trial INDP-D101 for its lead cancer immunotherapy candidate Decoy20.
Satellos Bioscience Initiates Phase 1 Trial of SAT-3247 for Duchenne Muscular Dystrophy
Satellos Bioscience has dosed the first healthy volunteer in a Phase 1 clinical study of SAT-3247, an oral small molecule drug targeting AAK1.
CanSino Biologics Initiates Phase I/II Trial of Recombinant Polio Vaccine in Indonesia
CanSino Biologics has commenced a Phase I/II clinical trial in Indonesia for its Recombinant Poliomyelitis Vaccine (CS-2036).
Puma Biotechnology Initiates Phase II Trial of Alisertib in HR+/HER2- Breast Cancer
Puma Biotechnology has commenced the ALISCA™-Breast1 Phase II trial to evaluate alisertib in hormone receptor-positive, HER2-negative advanced breast cancer.
NH130 Shows Promise in Phase I Trial for Parkinson's Disease Psychosis
NH130, a selective serotonin 5-HT2A inverse agonist, demonstrates favorable pharmacokinetics and safety in a Phase I trial for Parkinson's disease psychosis (PDP).
Bill Gates Optimistic About Progress in M72 Tuberculosis Vaccine Clinical Trial
Bill Gates expressed optimism about the M72 tuberculosis vaccine clinical trial, anticipating a 70% efficacy in reducing the disease.
Lipophilic Statins Linked to Reduced Hepatocellular Carcinoma Risk
A recent study utilizing data from the All of Us Research Program found that lipophilic statins, like atorvastatin and simvastatin, are associated with lower odds of hepatocellular carcinoma (HCC).
BeiGene's Tevimbra Approved in Israel for Advanced Esophageal Cancer
The Israeli Ministry of Health has approved Tevimbra (tislelizumab) as a monotherapy for unresectable or metastatic esophageal squamous cell carcinoma (OSCC).
Metformin Use Linked to Reduced Long COVID Risk in Diabetes Patients
A new study reveals that metformin, a common diabetes drug, may lower the risk of developing Long COVID or dying within six months of COVID-19 infection.
Microbot Medical Completes Trial for LIBERTY Surgical Robot, Eyes FDA Submission
Microbot Medical has concluded its ACCESS-PVI clinical trial for the LIBERTY endovascular surgical robot, with plans to submit a 510(k) application to the FDA by the end of 2024.
Triptans Outperform Newer Migraine Drugs in Efficacy, Meta-Analysis Shows
A comprehensive meta-analysis reveals that older triptan medications, like eletriptan, are more effective for acute migraine treatment than newer gepants.