01 February 2024
01 February 2024
As the UK pharmaceutical sector adopts the VPAG scheme, the question of how this will impact biosimilars comes to the forefront.
The shelving of Biogen’s troubled Alzheimer’s drug caps a turbulent journey, with Leqembi now receiving the company’s full attention.
The Nasa and US Navy-propelled company remains confident, with Defender CEO Barry Feinberg saying a meeting with the US Food and Drug Administration (FDA) has been requested.
CMS’ CGT Access Model will see allow the agency to negotiate negotiate pricing and build a framework that expands access to treatments.
The approval is based on data from a Phase III clinical trial in 195 patients.
The growth was primarily attributed to a surge in operating income and one-time favourable tax impacts.
The FDA has granted an orphan drug designation to Revolo’s ‘1104, with plans for a Phase IIb study later this year.
Protagonist is eligible to receive $300m as an upfront payment from Takeda.
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