North America: Food, Drugs, Healthcare, Life Sciences

On June 8, 2012, Genentech’s lawsuit seeking a declaration that US Patent No. 6,733,752 was invalid and not-infringed by Genentech’s trastuzumab product (HERCEPTIN).

Health Canada specifically contemplates certain proteins as SEBs in its Guidance, although Health Canada has not limited SEBs to only particular classes of drugs.

On May 23, 2012, the Federal Court held that Merck Frosst Canada Ltd. ("Merck") is liable to Apotex Inc. ("Apotex") for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations"), but exercised its discretion to reduce the amount of compensation payable based on a defence of ex turpi causa.

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.

Osler's Legislative Update is a bi-weekly listing of new legislation. This issue covers legislation for the period 07/10 to 07/23...

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)...

Durante la primera quincena del mes de julio de 2025, la Comisión Federal para la Protección contra Riesgos Sanitarios ("COFEPRIS") publicó diversos acuerdos relevantes en el Diario Oficial de la Federación ("DOF")...

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®.

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.