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Goodwin

Bio-Thera Announces Acceptance of BLA for BAT2506 Referencing Johnson & Johnson’s SIMPONI® (Golimumab)

Goodwin on

On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more

Foley & Lardner LLP

Cancer Drugs: Antibody-Drug Conjugate Litigation

Foley & Lardner LLP on

Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more

Smart & Biggar

2019 Mid-Year Highlights in Canadian Life Sciences IP

Smart & Biggar on

Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

Knobbe Martens

Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company

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Federal Circuit Summaries - Before Newman, Dyk, and Chen. Appeal from the Patent Trial and Appeal Board. Summary: An injury-in-fact is required to establish Article III standing for judicial review of agency action,...more

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