Tagged as: News

Biden Administration Proposes Biosimilar Substitution Without Interchangeability

The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability.  Specifically, the U.S. Department of Health & Human Services (HHS)’s 2025 proposed budget includes a budget-neutral provision for allowing biosimilar substitution without a separate determination…

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Katalin Karikó and Drew Weissman Awarded Nobel Prize in Physiology or Medicine For Discoveries Relating to mRNA Vaccines

Today, the Nobel Assembly at Karolinska Institutet announced that the Nobel Prize in medicine was awarded to Katalin Karikó and Drew Weissman “for their discoveries concerning nucleoside base modifications that enabled the development of effective mRNA [messenger RNA] vaccines against COVID-19.”  Dr. Karikó is a Professor at Szeged University and…

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Legal Challenges to the Inflation Reduction Act: An Update on Pending Challenges and Reactions to Oral Argument in Dayton Area Chamber Of Commerce et al. v. Becerra et al.

Two weeks ago, HHS announced the first 10 drugs that will be subject to the new Drug Price Negotiation Program under the Inflation Reduction Act (“IRA”). Six of the manufacturers whose drugs are on the list and several other interested groups have filed lawsuits challenging the Program. In one of…

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Biosimilars Webinar Series

In continuation of Goodwin’s previous webinar series concerning biosimilars, Big Molecule Watch is launching the 2023-2024 webinar series, which will dive deep into some of the key topics pertaining to this burgeoning industry and corresponding area of law. Stay tuned for more details, including registration information for upcoming webinars. So…

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New Guidance & Ongoing Litigation: Summer 2023 Updates on the Inflation Reduction Act’s Medicare Drug Pricing Negotiation Program

On June 30, 2023, the Centers for Medicare & Medicaid Services (CMS) released its updated final program guidance covering the Inflation Reduction Act’s Medicare Drug Price Negotiation Program for the first round of negotiations, which will occur during 2023 and 2024 and result in prices that will be effective beginning…

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