We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Multiple drugmakers have filed amicus briefs to the U.S. Supreme Court refuting a broad patent claim by Amgen that — if upheld — could have sweeping implications in drug development. Read More
Madrigal Pharmaceuticals’ nonalcoholic steatohepatitis (NASH) drug resmetirom might be a cost-effective treatment for the disease if priced at no more than $12,820 per year, according to a draft cost-benefit analysis by the Institutes for Clinical and Economic Review (ICER). Read More
Will the Pharmaceutical Research and Manufacturers of America (PhRMA) start losing more members this year in the wake of the powerful lobbying group’s inability to stop the 2022 Inflation Reduction Act (IRA) and all its cost-cutting measures aimed at the pharmaceutical industry? Read More
The updated labeling says healthcare providers should tell patients that taking antithrombotic or thrombolytic medications with Aduhelm may increase the risk of bleeding in the brain. Read More
More than one-fifth of the new drugs approved by the FDA from 2017 through 2020 were either refused marketing authorization or not recommended for reimbursement in Australia, Canada, or the UK due to unfavorable benefit-to-risk profiles, uncertain clinical benefit or unacceptably high price. Read More
Despite continuing pandemic conditions, the FDA’s Office of Pharmaceutical Quality (OPQ) was able to conduct 65 on-site pre-license inspections in 18 countries in 2022 — up from 47 in 2021 — and used remote regulatory assessments to gather information needed to move forward on 85 more submissions, according to OPQ’s just-released annual report. Read More
In response to President Biden’s call for drug price-lowering demonstration projects, HHS has proposed three pilot programs designed to make therapeutics more affordable for Medicare and Medicaid beneficiaries. Read More
In a unanimous vote of 15-0, members of two FDA advisory committees agreed that the benefits of over-the-counter (OTC) intranasal naloxone far exceed any risks the long-approved drug might carry. Read More
The committee will decide whether the marketing authorizations for pseudoephedrine-containing medicines should be “maintained, varied, suspended or withdrawn across the EU,” the agency said. Read More
Patients currently enrolled in the study will continue taking the investigational drug, but no new patients will be enrolled until the partial hold is lifted. Read More