Moderna pauses its RSV vaccine trial for children

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Washington – A pediatric vaccine for respiratory syncytial virus (RSV),a highly contagious, common respiratory virus that infects the nose, throat, and lungs, is on hold, per US Food and Drug Administration`s instructions. An FDA document shows that a phase 1 trial of two experimental Moderna RSV vaccines in infants aged five to eight months was paused in July as five …

PMPRB report reviews new drugs, impact on future spending in Canada

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Ottawa – The latest edition of Meds Pipeline Monitor, from the Patented Medicine Prices Review Board, provides stakeholders with a list of new medicines in the late stages of clinical evaluation that may significantly impact clinical practice or drug spending in the coming years. There were over 12,000 drugs in the pipeline in 2023, increasing by an average of 19% per …

PMPRB report examines availability and pricing of new medicines

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Ottawa – The Patented Medicine Prices Review Board (PMPRB) published the 8th edition of its annual Meds Entry Watch report today. The analysis finds that the number of new medicines launched in Canada is higher than the median for Organisation for Economic Co-operation and Development (OECD) countries., Most new medicines come to market with high treatment costs, and specialty medicines such as biologic, …

Canadian Minister of Health on nicotine replacement therapies

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Ottawa – Mark Holland, Minister of Health, gave the following statement on nicotine replacement therapies. He said: “As Minister of Health, I am incredibly concerned about the growing popularity and recreational use of nicotine replacement therapies, particularly nicotine pouches, among youth. Nicotine is a powerfully addictive substance, and children and teenagers are especially susceptible to the harmful effects of nicotine. …

FDA Approves Many New Drugs in 2023

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Washington – The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved a wide range of therapies in 2023 that will help patients and consumers live better and possibly longer lives. Therapies For Many Types of Diseases and Conditions In 2023, CDER approved 55 novel drugs, as detailed in our annual New Drug Therapy Approvals report. The …

Health Canada on FDA decision on Florida bulk drug import plan

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Ottawa – On January 5, the US Food and Drug Administration (FDA) approved the state of Florida’s plan to import select Canadian prescription drugs in bulk. The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation …

Health Canada approves RSV vaccine for expecting mothers

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Ottawa – Health Canada has approved a new vaccine to protect two groups most severely affected by the respiratory syncytial virus (RSV): newborns, who would receive antibodies through maternal immunization, and Canadians over 60. Pfizer Canada’s bivalent vaccine, called Abrysvo, aims to prevent lower respiratory tract disease caused by the virus. It is the first RSV vaccine in Canada approved …

FDA approves Biogen-Sage Therapeutics pill for postpartum depression

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Washington – The US Food and Drug Administration (FDA) approved Biogen BIIB.O and Sage Therapeutics’ SAGE.O oral pill to treat postpartum depression (PPD) in adults. The companies had sought the FDA’s approval for the drug, Zurzuvae, to treat major depressive disorderdrug, Zurzuvae, to treat major depressive disorder (MDD), or clinical depression, as well as postpartum depression, which affect millions of …