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ANDA applicants should submit a request for a PSG teleconference within 60 days after publication of a new or revised PSG so that the FDA can provide timely feedback, the agency said. Read More
TG Therapeutics would have to cut the price of its newly approved multiple sclerosis antibody Briumvi (ublituximab) by up to 84 percent to meet the same cost-effectiveness threshold as other monoclonal antibodies used to treat the disease, according to a report by the Institute for Clinical and Evidence Review (ICER). Read More
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