On Heels of FDA Nod, BridgeBio’s Rival to Blockbuster Pfizer Drug Wins European Approval

BridgeBio Pharma’s approval of Beyonttra comes three months after the drug landed FDA approval for cardiomyopathy caused by transthyretin amyloidosis. Our recap of recent regulatory news also spans approvals in cancer, immunology, vaccines, and more. The post On Heels of FDA Nod, BridgeBio’s Rival to Blockbuster Pfizer Drug Wins European Approval appeared first on MedCity…

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Can the NIH replace all private sector clinical R&D?

A paper by Proudman et al. (2024) finds that doing so would be extremely expensive. Including all preclinical, clinical and post-approval R&D activities, total annual costs to maintain the average lifecycle level of 49.4 approved drugs across all disease areas during the 2018–22 period was estimated to be $139.6 billion. Including only pre-launch costs, total…

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UNFPA Funding and Kemp-Kasten: An Explainer

This fact sheet provides an overview of the history of the Kemp-Kasten amendment, which states that no U.S. funds may be made available to “any organization or program which, as determined by the president of the United States, supports or participates in the management of a program of coercive abortion or involuntary sterilization,” and examines…

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