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Latest From Kate Rawson
US FDA's final patient-focused drug development meeting shows high interest clinical trial enrollment.
If FDA decides to replace Richard Moscicki, that individual will almost automatically be seen as Janet Woodcock’s heir-apparent at CDER, should she choose to retire.
Pricing of anti-addiction therapies could come under more pressure from HHS if Trump Administration accepts White House commission recommendation to declare public health emergency on opioid crisis.
Industry's promotion and pricing behavior was a non-factor during the Christie-chaired meeting, which featured testimony from nine non-profit organizations working to resolve the opioid epidemic.
Using lessons learned from the first wave of biosimilar approvals – and citing high prices in the US – some developers are starting to 'think small' with biosimilars for rare disease markets. Alexion’s Soliris is a case in point.
Given that 'right to try' is intended to be a patient-centered proposal, patient organizations are a strong voice in opposition, working behind the scenes to revise – or entirely exclude – the legislation as part of the user fee package. But the bill also has powerful advocates among Senate Republicans and in the Trump Administration.