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
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
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
Canada has approved the first oral COVID-19 treatment that can be taken at home. The drug, an antiviral developed by Pfizer, was found to reduce risk of hospitalization and death by 89 percent in clinical trials. At the moment, there is a “limited global supply” of the drug, thus Canadian health officials have prioritized the
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
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
Last summer, we reported that Health Canada and the FDA were beginning a series of meetings to discuss how Canada and the U.S. could work together to make their drug approval processes more efficient. At that time, they announced the formation of a council (it’s called the Canada-US Regulatory Cooperation Council, or RCC) to look
Health Canada (HC) and the Food and Drug Administration (FDA) are meeting for the first time on May 15th, 2015 to begin discussions on how the United States and Canada can make their drug approval processes more efficient. With Prime Minister Stephen Harper’s and President Barack Obama’s backing, the two agencies have formed a council