Firm’s aggressive approach to amyloid plaque removal means a shorter duration of treatment and potentially lower costs.
Eli Lilly and Company believes its treatment approach for donanemab in early Alzheimer’s disease can be a cost saver that would enhance the drug’s appeal to payers.
In the company’s TRAILBLAZER ALZ-2 clinical trial, patients on donanemab were switched to placebo once they achieved substantial amyloid plaque clearance
Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.
President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.
Brazil’s drug pricing authorities are planning to introduce, among other things, a new drug category for biosimilars to ensure the pricing procedures for such medicines are reflected in the official pricing framework.
Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.
Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.
Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
