News & Insights

News & Insights

News 192 results

In the News · Source: WBUR On Point

March 16, 2023
Eva Temkin explains why a Texas lawsuit attempting to ban pills used in medical abortions could have an impact on how the FDA approves medicines

In the News · Source: Bloomberg Law

March 10, 2023
John Shakow discusses the administrative dispute resolution rule for the 340B drug discount program and its impact on manufacturers

In the News · Source: Pink Sheet

February 27, 2023
Eva Temkin discusses how organizations, states and courts are impacting the FDA’s ability to approve and regulate drugs

In the News · Source: Bloomberg Law

February 22, 2023
Eva Temkin explains how legal challenges could arise if CMS relies on guidance instead of rulemaking to meet the timeline Congress has set in the Inflation Reduction Act to begin negotiating certain drug prices

In the News · Source: AgFunderNews

February 20, 2023
Dale Giali comments on Miyoko’s Creamery filing a lawsuit against its founder Miyoko Schinner that accuses her of stealing its IP after being removed as CEO in June 2022

In the News · Source: FDAnews

February 14, 2023
Beverly Lorell comments on issues of data integrity and why it represents high stakes for both sponsors and clinical investigators

In the News · Source: Politico

February 10, 2023
K&S to lobby on behalf of Taurx Pharmaceuticals

Recognition

February 7, 2023
King & Spalding Lawyers Named to Leadership Council on Legal Diversity Fellowship, Pathfinder Programs

In the News · Source: Pink Sheet

February 6, 2023
Eva Temkin explains why the prospects for litigation could increase if CMS relies on guidance to impose the Inflation Reduction Act’s strict financial penalties on manufacturers who do not cooperate with the process

In the News · Source: Law360 and Bloomberg Law

January 30, 2023
K&S represents Novo Nordisk before the Third Circuit, which ruled in favor of the pharmaceutical company in its dispute with the U.S. Department of Health and Human Services over the Public Health Service Act's 340B program

In the News · Source: The Wall Street Journal, The New York Times, ABC News, Law360, Politico, Bloomberg Law and Ms. Magazine

January 25, 2023
Eva Temkin, Chelsea Corey, Paul Mezzina and Jessica Greenbaum counsel a doctor with a federal preemption challenge to strike down North Carolina’s restrictions on the abortion drug mifepristone

In the News · Source: STAT

January 25, 2023
Eva Temkin discusses the impact of Congress increasing the FDA’s authority over the post-market clinical trials that are a condition of speedy drug approvals