Search Results for:

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…

Read More

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…

Read More

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…

Read More

Think You Don’t Need to Worry About Patents Before Commercializing Your Gene or Cell Therapy Product? Think Again! The Safe Harbor and Lessons Learned from REGENXBIO v. Sarepta.

Many pre-commercialization gene or cell therapy companies are aware of the patents that could threaten their product after launch, but assume that they are protected from patent infringement suits before they obtain FDA approval and sell their products under the so-called “safe harbor.” In this webinar on August 2, 2023,…

Read More

Natasha Daughtrey to Speak at ACI’s 14th Annual Summit on Biosimilars & Innovator Biologics

The 14th Annual American Conference Institute’s (ACI) Summit on Biosimilars & Innovator Biologics will be held on June 27-28, bringing together the “who’s who” of the biosimilars and innovator biologics industries as they gather to discuss and contemplate the impact of critical developments in these industries: biologics becoming the fastest-growing…

Read More