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Under the terms of the agreement, Cugene will receive an upfront payment of $48.5 million, plus additional payments for reaching developmental or regulatory milestones. Read More
A collection of 24 states is displaying its support to the Department of Health and Human Services (HHS) in its legal fight with several drugmakers over access to drugs discounted under the 340B Drug Discount program. Read More
The Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices voted yesterday to recommend that children between the ages of five and 11 should receive booster doses of the Pfizer-BioNTech COVID-19 vaccine. Read More
FDA Commissioner Robert Califf announced a new role for agency veteran Janet Woodcock in his remarks at a House subcommittee hearing yesterday, where he was slated to speak on the agency’s fiscal 2023 budget request. Read More
In a congressionally mandated report on diversity in clinical trials, the National Academies of Sciences, Engineering and Medicine (NASEM) recommends the FDA require drug sponsors to file an in-depth recruitment strategy, either before or with their investigational new drug (IND) or investigational device exemption (IDE) applications, that details how they intend to make their trial population reflective of the disease or condition’s demographics. Read More
A federal court has thrown out a rule that forced pharma companies to include discounts they offer to patients when calculating the so-called best price for Medicaid’s drug rebate program. Read More
The Department of Health and Human Services recommended that the product be kept available for an extra six months for possible use against new variants or subvariants that could become dominant in the U.S. Read More