United States: Food, Drugs, Healthcare, Life Sciences

As the immune checkpoint inhibitor (ICI) market nears a patent cliff, the $50B immuno-oncology (IO) field is now seeking to surpass the limitations of earlier ICIs by enhancing survival outcomes...

On July 31, 2025, the White House released a fact sheet discussing additional steps taken by the Trump administration surrounding efforts towards lowering drug prices for Americans. The fact sheet was a follow-up to Executive Order (EO) 14297 signed May 12, 2025

On August 20, 2025, the United States Court of Appeals for the Ninth Circuit affirmed the dismissal of a putative class action asserting claims under the Securities Exchange Act of 1934...

As the immune checkpoint inhibitor (ICI) market nears a patent cliff, the $50B immuno-oncology (IO) field is now seeking to surpass the limitations of earlier ICIs by enhancing survival outcomes...

In the dynamic realm of Pharmacy Benefit Manager (PBM) oversight and regulation, the recent successful reversal of discrepancies identified during an audit represents...

In the rapidly changing landscape of healthcare, pharmacy benefit managers (PBMs) are increasingly under scrutiny for their significant influence on prescription drug pricing and patient access.

As the immune checkpoint inhibitor (ICI) market nears a patent cliff, the $50B immuno-oncology (IO) field is now seeking to surpass the limitations of earlier ICIs by enhancing survival outcomes...

The Department of Justice (DOJ) and the Department of Health and Human Services (HHS) recently announced the DOJ-HHS False Claims Act Working Group...

On July 31, 2025, the White House released a fact sheet discussing additional steps taken by the Trump administration surrounding efforts towards lowering drug prices for Americans. The fact sheet was a follow-up to Executive Order (EO) 14297 signed May 12, 2025

In Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit upheld the district court’s determination that the claims at issue were neither obvious nor invalid under the doctrine of obviousness-type double patenting based on a "lead compound" approach to the obviousness determinations.

After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101.

GlaxoSmithKline and Genentech have settled a U.S. lawsuit related to Genentech's Cabilly II (US 6,331,415) and Cabilly III (US 7,923,221) patents.