United States: Food, Drugs, Healthcare, Life Sciences

On September 9, 2025, the U.S. Food and Drug Administration ("FDA") Office of Prescription Drug Promotion ("OPDP") issued numerous untitled letters as part of the agency's wider attack...

Expected New Drug Pricing Model: We anticipate the Centers for Medicare & Medicaid Services (CMS) to release a significant proposed new drug pricing model through its Innovation Center...

As indicated in our previous post, the US Food and Drug Administration (FDA) and the Department of Justice (DOJ) created a joint task force including the Bureau of Alcohol, Tobacco, Firearms...

Expected New Drug Pricing Model: We anticipate the Centers for Medicare & Medicaid Services (CMS) to release a significant proposed new drug pricing model through its Innovation Center...

As indicated in our previous post, the US Food and Drug Administration (FDA) and the Department of Justice (DOJ) created a joint task force including the Bureau of Alcohol, Tobacco, Firearms...

DentalForum USA is an event series tailored specifically for DSOs, group practices and dental industry vendors.

On September 9, 2025, the U.S. Food and Drug Administration ("FDA") Office of Prescription Drug Promotion ("OPDP") issued numerous untitled letters as part of the agency's wider attack...

Expected New Drug Pricing Model: We anticipate the Centers for Medicare & Medicaid Services (CMS) to release a significant proposed new drug pricing model through its Innovation Center...

Last week, on September 25, 2025, Judge O'Connor in the U.S District Court for the Northern District of Texas ruled in favor of Humana (the Humana Decision)...

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.