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The FDA is considering asking Congress for enhanced authority over opioid approvals and marketing to ensure that new products offer “material safety advantages” over existing approved opioid analgesics. Read More
The FDA has released new details for companies preparing to submit an abbreviated new drug application (ANDA) on how to request meetings relating to a new or revised product-specific guidance (PSG) that may impact their application. Read More
Members of the Senate Commerce Committee heard testimony yesterday from panelists mostly in favor of a recently reintroduced bill that would compel pharmacy benefit managers (PBM) to be transparent about their pricing practices and to get them to stop unfair or deceptive conduct that drives up costs for consumers. Read More
Multiple drugmakers have filed amicus briefs to the U.S. Supreme Court refuting a broad patent claim by Amgen that — if upheld — could have sweeping implications in drug development. Read More
Madrigal Pharmaceuticals’ nonalcoholic steatohepatitis (NASH) drug resmetirom might be a cost-effective treatment for the disease if priced at no more than $12,820 per year, according to a draft cost-benefit analysis by the Institutes for Clinical and Economic Review (ICER). Read More
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