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.
Several chambers of commerce have sued HHS and CMS over the Inflation Reduction Act (IRA) claiming that the prescription drug price control program is “a violation of America’s fundamental constitutional requirements of limited government, property rights, the rule of law, and the separation of powers.” Read More
The FDA sketched out how it is implementing the fee structure of the Generic Drug User Fee Amendments of 2022 (GDUFA III) in a final guidance released Friday. Read More
The FDA should be as willing to withdraw an accelerated approval as to grant it, write a team of researchers, arguing for a balance between speed and certainty. Read More
The FDA has finalized its guidance on drug-drug interaction (DDI) studies of investigational drugs with combined oral contraceptives (COC), outlining when these studies are and aren’t needed, how to design them and how to communicate findings. Read More
The FDA will not let Intarcia choose reviewers for the upcoming Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to consider the company’s troubled diabetes drug-device product, nor will the agency grant other requests Intarcia made last month. Read More
Eisai’s Leqembi and AstraZeneca’s nirsevimab are both poised for a greenlight from the FDA if agency briefing documents prepared for two advisory committee meetings this week are any indication. Read More
Biotech firm Promosome is the latest company to sue big pharma for infringing on its patent for messenger RNA (mRNA) technology during the rush to develop a COVID-19 vaccine, claiming in separate filings that Moderna and Pfizer reaped enormous profits using Promosome research. Read More
The FDA has selected the initial applications for participation in its Advancing Real-World Evidence (RWE) program, which allows pharmaceutical sponsors four meetings with the agency to discuss proposals to use RWE in drug development. Read More
Merck is suing the federal government over the landmark $740 billion Inflation Reduction Act (IRA), questioning the constitutionality of the nearly year-old law designed to lower drug costs. Read More