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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the marketing authorizations for pseudoephedrine-containing medicines should be “maintained, varied, suspended or withdrawn across the EU,” the agency said.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
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
By the end of March, the Center for Drug Evaluation and Research (CDER)’s Office of Strategic Programs (OSP) will have met its first Prescription Drug User Fee Act (PDUFA) VII goal: enhancing internal systems review of digital health technology (DHT)-related submissions — enabling the agency to better receive and digest submissions that contain reams of data from, for example, wearable devices. Read More