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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
Reacting to concerns about good clinical practice at sites run by one of its trial contractors — Boston-based Care Access — Pfizer announced it will drop Care Access sites from its phase 3 Lyme disease vaccine trial, losing about 3,500 participants. 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
The updated labeling says healthcare providers should tell patients that taking antithrombotic or thrombolytic medications with Aduhelm may increase the risk of bleeding in the brain. Read More