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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
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the marketing authorizations for pseudoephedrine-containing medicines should be “maintained, varied, suspended or withdrawn across the EU,” the agency said.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
The FDA has issued a complete response letter (CRL) to Biocon and Viatris over their biologics license application (BLA) for bevacizumab, a proposed biosimilar of Roche’s blockbuster cancer drug Avastin. Read More
Ten percent of new drug approvals in the U.S. from 2018 to 2021 were based on pivotal studies that failed to meet at least one primary endpoint, according to a new report that concludes the FDA needs to be more transparent about its approval decisions. Read More
The concept of a multi-national concurrent review process for cell and gene therapies based on the current international partnership Project Orbis is just that — a concept with no immediate timeline for launching such an effort, according to a top FDA official. Read More