Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more
The Medicare drug price negotiation provision in the 2022 Inflation Reduction Act treats small molecule drugs and biological products differently. For small molecules, drug price negotiations can start seven years after Food...more
On April 15, 2025, President Trump issued an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order reaffirms and seeks to expand on policy initiatives introduced during the president’s...more
As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024....more
On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more
The Cozen Lens - While it’s becoming ever clearer Vice President Harris is likely to be the Democratic nominee following President Biden’s decision to step aside, it’s less clear what the impact will be on the presidential...more
Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
August 16, 2023 marked the one-year anniversary of the enactment of the Inflation Reduction Act (“IRA”). The first 365 days since the IRA’s passage brought the implementation of a number of significant changes to the Medicare...more
The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more
The Inflation Reduction Act (IRA), signed into law on August 16, 2022, allows the federal government to negotiate prices for some high-cost drugs covered under Medicare. ...more
This morning the Centers for Medicare & Medicaid Services (CMS) published, for the first time, a list of drugs subject to price negotiation under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation program....more
This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more
On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated final guidance (“Final Guidance”) for the Medicare Drug Price Negotiation Program (“Negotiation Program”) through the...more
On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an initial guidance regarding the Medicare Drug Price Negotiation Program (Negotiation Program) established by the Inflation Reduction Act of 2022...more
2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more
Under Section 11403 of The Inflation Reduction Act, effective starting on Monday, October 3, 2022, and for the next five years, Medicare Part B will pay healthcare providers an 8% add-on fee for qualifying biosimilars,...more
Key Points - The new drug price negotiation process under the IRA takes into account a complex mix of price, competitive status, market exclusivity and scientific data. New price setting provisions built into the IRA...more
In the first of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe discussed the Drug Price Negotiation Program established by...more
After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more