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
Biosimilars 2018 - A Year in Review
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
Join our 2024 Mid Year Pharmacy Benefits Update webinar for a comprehensive analysis of the current pharmacy landscape. This informative session will delve into key trends, including the evolving biosimilars market, the...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
The Inflation Reduction Act of 2022 (IRA) includes the most dramatic change to U.S. drug price regulation in history. The new law allows the federal government to “negotiate” the price of many drugs dispensed to Medicare...more
In late 2019, Congress enacted the “CREATES Act”, which established a private right of action in which generic or biosimilar manufacturers may sue an innovator for an injunction and monetary award for not selling samples of...more
We are just one quarter into 2022 and the Food and Drug Administration (FDA) already has experienced a number of significant changes and developments. A new commissioner has been confirmed (Robert Califf, M.D., who previously...more
15 Years of Pharma & Biotech Patent Litigation in Europe - C5’s Pharma & Biotech Patent Litigation in Europe will take place 23–24 February, 2022 in Amsterdam, the Netherlands. This is the only industry-shaping event that...more
After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more
This year, the BPCIA turns 10! As we prepare to enter the next decade of this revolutionary law, we cordially invite you to join us for ACI’s 11th Annual Biosimilars & Innovator Biologics Summit, in a fully virtual,...more
Hear from the FDA and the leaders of the biosimilars and innovator biologics industries about the impact of the pandemic on the global IP market and gain practical guidance for what is coming down the pipeline. The novel...more
Next Tuesday (December 5) between 1:00-2:30pm (EST), FDA’s Division of Drug Information is presenting a webinar titled an “Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the...more
There’s been a sea change in the political climate. The regulatory forecast is still uncertain, and pharmaceutical evolution continues to develop....more
The greatest asset of a young biotech company is its intellectual property. Strategic decisions made during the initial organization and early growth of your company have a lasting impact on its success. In this webinar, we...more