United States: Food, Drugs, Healthcare, Life Sciences

On July 17, 2025, Harrow, Inc. ("Harrow"), announced an agreement with Samsung Bioepis Co. Ltd. ("Samsung Bioepis") to acquire the U.S. commercial rights to two of Samsung Bioepis's biosimilars, BYOOVIZ®...

Louisiana's Senate Bill 14 introduces a first-of-its-kind QR code labeling mandate for food products containing any of 44 specified ingredients, effective Jan. 1, 2028.

On Monday, July 14, The Centers for Medicare and Medicaid Services (CMS) released its annual proposed rule for the Calendar Year (CY) 2026 Medicare Physician Fee Schedule.

On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection)...

On July 16, 2025, Bio-Thera Solutions, Ltd. announced that the U.S. Food and Drug Administration had accepted its Biologics License Application for its golimumab biosimilar, BAT2506, referencing Johnson & Johnson's SIMPONI®.

CYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS)...

Louisiana's Senate Bill 14 introduces a first-of-its-kind QR code labeling mandate for food products containing any of 44 specified ingredients, effective Jan. 1, 2028.

On Monday, July 14, The Centers for Medicare and Medicaid Services (CMS) released its annual proposed rule for the Calendar Year (CY) 2026 Medicare Physician Fee Schedule.

A Notice published on July 14, 2025 identifies 12 new Federal public benefit programs (see list below) for which non-qualified aliens are not eligible.

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.