What is COPD, Nucala for COPD treatment

La FDA approuve Nucala pour les patients atteints de MPOC avec un taux élevé d’éosinophiles

Santé et bien-être, Développement de médicaments, Santé Canada et la FDA, Nouvelles de l’industrie, Résultats d’étude, MPOC

La Food and Drug Administration (FDA) des États-Unis a approuvé Nucala (mépolizumab) comme traitement d’appoint pour les adultes atteints de maladie pulmonaire obstructive chronique (MPOC) qui continuent de présenter des exacerbations malgré une triple thérapie inhalée. Nucala est le premier médicament biologique spécifiquement approuvé pour les patients MPOC présentant un « phénotype éosinophilique » — un groupe

chronic kidney disease, Ozempic kidney disease approval

Ozempic Now Approved for Kidney Disease Treatment

Obesity & Weight Loss, Drug Development, Health Canada & FDA, Industry News, Health and Wellness

The FDA has approved Novo Nordisk’s drug Ozempic for a new use: reducing the risk of kidney disease worsening, kidney failure, and death from cardiovascular disease in adults with Type 2 diabetes and chronic kidney disease (CKD). This approval is significant because Ozempic is now the first drug in its class (GLP-1 receptor agonists) with

hypertriglyceridemia

Arrowhead Pharmaceuticals’ New Drug Plozasiran Shows Promise in Treating Rare Genetic Disease

Heart Health, Drug Development, Health Canada & FDA, Industry News, Health and Wellness, Study Results

Arrowhead Pharmaceuticals announced positive results from its Phase 3 PALISADE study on plozasiran, a new drug for treating familial chylomicronemia syndrome (FCS). FCS is a rare genetic condition that causes extremely high triglyceride levels, leading to serious health issues like acute pancreatitis. Currently, there are no approved treatments for FCS in the United States or

vaccine

US Food and Drug Administration Approves New Pneumococcal Vaccine

Drug Development, Health Canada & FDA, Industry News, Study Results

Merck & Co.’s new vaccine, CAPVAXIVE (V116), has been approved by the FDA for preventing invasive diseases and pneumonia in adults 18 and older caused by specific strains of the bacteria Streptococcus pneumoniae. This vaccine is particularly aimed at protecting adults over 50 from around 84% of invasive pneumococcal diseases. In several studies, CAPVAXIVE showed

FDA Approves World’s First Respiratory Syncytial Virus (RSV) Vaccine for Older Adults

Drug Development, Health Canada & FDA, Industry News, Study Results

The US Food and Drug Administration (FDA) has granted approval to GlaxoSmithKline (GSK) for Arexvy, the world’s first vaccine designed to protect older adults against respiratory syncytial virus (RSV). RSV is a common respiratory virus that can cause serious illness, particularly in adults over 65 years of age, and in infants and young children. It

Vir and GSK Break Ground in COVID-19 Treatment Study

COVID, Drug Development, Health Canada & FDA, Study Results

UPDATE 28/10/2021 Dr. Gupta’s work as lead researcher on this study has been published in The New England Journal of Medicine, in an article titled Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. You can find a link to the article on The Journal‘s website, here: https://www.nejm.org/doi/full/10.1056/NEJMoa2107934?query=featured_home UPDATE 30/8/2021 Dr. Gupta has given two

FDA Guidelines for Conducting Clinical Trials During COVID-19 Pandemic

Drug Development, Health Canada & FDA, Study Results

The Food and Drug Administration (FDA) of the United States of America has recently issued a statement, updating Research Sites, Investigators, and IRBs on how best to deal with the ongoing challenges posed by COVID-19. These guidelines will help ensure the safety of trial participants, compliance with good clinical practice (GCP), and minimizing risks to