News & Insights

News & Insights

Innovative Drug, Biologic, and Device Development

News 31 results

In the News · Source: PharmaCircle

October 21, 2025
Kyle Sampson comments on FDA drug approvals slowing down as a result of budget cuts and the government shutdown

In the News · Source: Global Legal Chronicle, Law360 Pulse and The AmLaw Litigation Daily

July 31, 2025
K&S secures a complete defense verdict on behalf of CG Oncology in a dispute with ANI Pharmaceuticals over future royalties on net sales of cretostimogene or, in the alternative, $2.3B in unjust enrichment damages

Cases & Deals

July 29, 2025
King & Spalding Secures Complete Defense Verdict for CG Oncology in Defense of Future Royalties and $2.3 Billion Unjust Enrichment Claim

In the News · Source: Law360 Healthcare Authority

July 22, 2025
Lisa Dwyer discusses the impact of the FDA recently publishing more than 200 rejection letters for new drug applications

In the News · Source: Law360

October 24, 2024
Jeffrey Telep, Chris Campbell, Brit Davis, Brian Hill and Katherine Vessels counsel Composite Resources and North American Rescue before the U.S. International Trade Commission

In the News · Source: InsideHealthPolicy

May 8, 2024
Lisa Dwyer discusses the FDA’s struggle to review Moderna and Merck's mRNA-4157 melanoma cancer vaccine candidate as the companies used artificial intelligence to determine the formulation of the individualized vaccine

In the News · Source: Bloomberg Law and 340B Report

April 22, 2024
John Shakow comments on the HHS’s Health Resources and Services Administration’s newly re-established Administrative Dispute Resolution Panel for the federal 340B drug discount program

In the News · Source: STAT+

February 15, 2024
Lisa Dwyer comments on the FDA cracking down on websites that claim to sell the underlying chemicals of popular diabetes and obesity drugs like Ozempic, Wegovy, and Zepbound

In the News · Source: Pink Sheet

January 30, 2024
Eva Temkin discusses the recent influx of accelerated approval oncology indications or drugs that have been withdrawn or requested withdrawn

In the News · Source: Pink Sheet

January 29, 2024
Eva Temkin comments on the Food and Drug Omnibus Reform Act giving the U.S. FDA authority to require that confirmatory trials be underway at the time of accelerated approval

In the News · Source: POLITICO Pro and POLITICO Pulse

January 23, 2024
Lisa Dwyer explains how the FDA’s efforts on social media to communicate drug safety warnings to the public could be impacted based on the outcome of a lawsuit over the prescribing of ivermectin as a Covid-19 treatment

In the News · Source: Bloomberg Law

January 9, 2024
Kyle Sampson explains why political pressure on state governors to import drugs are likely to encourage other states to pursue Canadian import programs