Your search for ‘Goodwin Procter LLP’ returned 4,550 results

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies...

On May 10, 2022, Formycon AG and ATHOS KG announced that they have closed a transaction regarding the biosimilar assets FYB201 and FYB202.

On February 11, 2026, Formycon AG and Lotus Pharmaceutical announced the execution of an exclusive license agreement directed to Formycon's pembrolizumab biosimilar candidate, FYB206.

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®...

On February 4, 2025, HyClone Laboratories, LLC ("HyClone"), a cell culture media supplier, filed a Motion to Quash a subpoena issued by Amgen, Inc. ("Amgen").

On December 3, 2024, Accord BioPharma, Inc. ("Accord"), the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas"), announced an agreement to acquire...

On March 30, 2022, Fresenius Kabi announced that the European Commission approved STIMUFEND, a pegfilgrastim biosimilar referencing NEULASTA...

A federal court in Delaware has granted Janssen's motion for a preliminary injunction against Accord BioPharma and Bio-Thera Solutions, halting the manufacture, sale, and importation of their golimumab biosimilar BAT2506 in the United States. The injunction requires Janssen to post a $98.8 million bond while the underlying patent dispute continues through litigation and inter partes review proceedings at the USPTO.

JSR Life Sciences recently announced its launch of a new business division, "Similis Bio," intended to help biosimilar drug developers "improve the efficiency and cost of biosimilar development."

On September 26, Amneal Pharmaceuticals, Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ADL-018, a proposed biosimilar...

Under Section 11403 of The Inflation Reduction Act, effective starting on Monday, October 3, 2022, and for the next five years, Medicare Part B will pay healthcare providers an 8% add-on fee for qualifying biosimilars, replacing the previous 6% markup.

On January 10, 2025, Teva Pharmaceutical Industries Ltd. and Samsung Bioepis Co., Ltd. announced

On March 30, 2026, Teva Pharmaceutical Industries Ltd. ("Teva") announced that the U.S. Food and Drug Administration ("FDA") has approved its denosumab biosimilar, PONLIMSI™ (denosumab-adet).

On February 7, 2023, Texas filed a lawsuit against the Biden administration challenging guidance issued by the Department of Health and Human Services ("HHS") to retail pharmacies in June of last year.

For sponsors utilizing a data monitoring committee in their trial designs to monitor for emerging safety signals, lack of effect, and/or futility of treatment...

There are four pending BPCIA litigations brought by Amgen against biosimilar companies seeking to market denosumab biosimilars.

In honor of Women's History Month, Big Molecule Watch recognizes Brigitte "Ita" Askonas, widely regarded as the mother of modern immunology.

In honor of Women's History Month, Big Molecule Watch recognizes Emmanuelle Charpentier and Jennifer Doudna, who won the Nobel Prize for a method for genome editing, commonly called CRISPR....