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CMS Issues Guidance and Solicits Comment on the 2026 Inflation Reduction Act Part D Negotiation Process

On April 5, 2023, Goodwin’s Matt Wetzel and Heath Ingram published a client alert addressing the initial guidance memorandum issued by the Centers for Medicare & Medicaid Services (CMS) on the Medicare Drug Price Negotiation Program created by the Inflation Reduction Act of 2022. Public comments are due to CMS…

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Goodwin to Host a Conversation on March 1 with Rare Disease Community Leaders

Goodwin’s Life Sciences team does extensive work with innovators in the rare disease space. In recognition of Rare Disease Day and participation in the National Organization for Rare Disorders’ (NORD) Rare Disease Day campaign to raise awareness, Goodwin’s Boston, DC, Silicon Valley and Santa Monica offices were lit in rare…

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Now Available! Updated Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S., 2022-2023

As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…

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