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“In order to make medicines more affordable for patients, we must address the role hospital markups play in driving up medicine costs,” said PhRMA CEO Stephen Ubl. Read More
PhRMA released a new report Wednesday highlighting the role of U.S. hospitals in increasing drug costs, showing they mark up prices for patients by an average of nearly 500 percent. Read More
The FDA issued new guidance for sponsors of drugs designed to treat hay fever as well as other cold-like symptoms that aren’t caused by allergies. In a pair of final guidances released Wednesday, the agency urges drug sponsors to focus on real-world settings when trying to determine ideal doses. Read More
With just two months left in the fiscal year and an average of 67 approvals a month, the agency is poised to break the previous year’s record. Read More
The FDA released final guidance Tuesday for drug sponsors on the content and formatting of physiologically-based pharmacokinetic (PBPK) analyses, including an expanded section on formatting and a simplified section on software. Read More
FDA Commissioner Scott Gottlieb repeated the agency’s commitment to biosimilars and stakeholders urged the agency to do more to improve market access during a public meeting Tuesday. Read More
Westminster Pharmaceuticals recalled two of its thyroid drugs after manufacturing them with APIs sourced from a Chinese supplier the FDA cited for GMP violations. Read More