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
JoinAStudy.ca Investigators Dr. Peter Dzongowski, Dr. Michael Jones and Dr. Sean Peterson were all recently involved in GSK trial AReSVi 006, evaluating a vaccine candidate for Respiratory Syncytial Virus (RSV). Recruitment was highly successful for all three investigators, whose work has helped lead to the first RSV vaccine candidate to show statistically significant and clinically
JoinAStudy.ca Investigator Dr. Anil Gupta was recently asked to assist in the presentation of strategies for preventing COVID progression and transmission in the outpatient setting, including the latest therapeutic developments. This effort was supported by an educational grant from Merck Sharp & Dohme Corp. The presentation linked below will define the sub-populations that are most
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
London, UK, 9 September 2021 – Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical candidates, has announced positive high-level results from the MANDALA and DENALI Phase III trials of a new, fixed-dose combination inhaler for those who suffer from asthma. JoinAStudy.ca Investigators Dr. Syed Anees, Dr. Peter Dzongowski, Dr. Anil Gupta, Dr. Sam Henein and Dr. Sean
Arthritis is a chronic and debilitating disease identified by symptoms such as joint pain, stiffness, swelling and decreased range of motion. The two most common types of arthritis are osteoarthritis (OA) and rheumatoid arthritis (RA). It is estimated that over 4.6 million Canadians suffer from arthritis, and it is a leading cause of disability. A
Approximately 550,000 Canadians suffer from the neurodegenerative disease known as Alzheimer’s Disease, which is also the cause of 60% to 70% of cases of dementia. This disease is associated with symptoms such as memory loss, difficulty performing simple tasks, disorientation of time and space, and even sudden changes in mood or personality. It is a
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