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Organon, a global woman's health company, recently announced its launch of two biosimilar products in Canada.

On January 11, 2026, the FDA issued two news releases putting forward reforms to the chemistry, manufacturing, and control requirements for cell and gene therapy products.

On September 9, 2025, the District Court for the Northern District of West Virginia entered a Stipulation and Order dismissing all claims and counterclaims...

Teva Pharmaceutical Industries Ltd. ("Teva") and Shanghai Fosun Pharmaceutical (Group) Co. ("Fosun Pharma") recently announced a partnership to accelerate...

On May 31, 2024, the CFPB announced that it had filed suit against a Pennsylvania-based student loan servicer for engaging in allegedly unfair, deceptive and abusive acts or practices in violation of the CFPA...

On August 30, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, "Alexion") and Samsung Bioepis Co. Ltd. ("Samsung Bioepis") settled their BPCIA dispute related...

As we previously reported, on June 28, 2020, Genentech, Inc. ("Genentech") filed a complaint against Samsung Bioepis Co., Ltd. ("Samsung") in the District of Delaware, alleging infringement of fourteen patents...

On April 3, 2025, GlaxoSmithKline (GSK) and Pfizer filed a stipulation to dismiss with prejudice GSK's litigation in the United States District Court for the District of Delaware.

This is Genentech's fifth BPCIA litigation against a trastuzumab biosimilar developer.

The USPTO has proposed several fee changes for implementation in 2025. If implemented, these changes will increase filing fees for Inter Partes Reviews (IPRs)

On March 3, 2022, the PTAB instituted another inter partes review of U.S. Patent Nos. 8,580,264 ("the '264 patent"), owned by Chugai and Roche.

As we previously reported, Mylan recently filed three IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept...

Last week, Regeneron filed a motion to terminate IPR2023-00620, an IPR filed by Celltrion on February 28, 2023, seeking cancellation of claims 1-4 of Regeneron's U.S. Patent No. 10,406,226 which is generally...

Under the P4P, Applicants can file a petition for expedited examination of a patent application that recites a method of treating cancer using immunotherapy.

On February 24, the USPTO extended the written comment period for Joint USPTO–FDA Collaboration Initiatives until March 10, 2023. As we previously reported, the USPTO requested public input...

The USPTO recently issued a notice of proposed rulemaking regarding terminal disclaimers.

On October 12, 2023, the Federal Trade Commission (FTC) and the Consumer Financial Protection Bureau (CFPB) announced that they filed a joint complaint​ and obtained a $15 million settlement​ against...

In October 2025, the Bank Policy Institute (BPI) issued a series of letters opposing efforts by several digital asset and payment firms to secure federal banking charters from the Office of the Comptroller of the Currency (OCC). BPI raised concerns that these companies are seeking trust charters even though, in BPI's view, they will not operate as traditional chartered financial institutions...