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FDA Approves BMS and J&J CAR-T Cell Therapies for the Earlier Treatment of Multiple Myeloma

On April 4, 2024, Bristol Myers Squibb (“BMS”) and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI),…

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Year in Review: Top Deals in 2023

According to PWC, “2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels.” Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the…

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Acuitas Files Suit Against CureVac Alleging Incorrect Inventorship on COVID MRNA-LNP Vaccine Patent Family

Acuitas Therapeutics Inc. (“Acuitas”) filed a complaint on November 13 against CureVac in the U.S. District Court for the Eastern District of Virginia, alleging incorrect inventorship of four U.S. Patents related to COVID-19 mRNA-LNP vaccines and assigned to CureVac, namely U.S. Patent Nos. 11,241,493, 11,471,525, 11,576,966, and 11,596,686, (collectively, the…

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Amneal Expands Oncology Offering with Two Denosumab Biosimilars

On October 12, Amneal announced that it will be adding two denosumab biosimilars to its oncology pipeline, referencing PROLIA and XGEVA. Denosumab is indicated for bone metastasis from various forms of cancer and for the prevention of bone pain and fractures, including osteoporosis-related injuries. Amneal announced that mAbxience will develop…

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Celltrion Expands Access to YUFLYMA (adalimumab-aaty)

On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM’s.”  According to the press release, YUFLYMA (adalimumab-aaty) will be a…

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Acuitas Seeks Declaratory Judgment of Non-Infringement and Invalidity Against Arbutus and Genevant in New Jersey Court Challenging mRNA-Delivery Specific Patents

Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus), challenging U.S. Patent Nos. 9,364,435; 8,058,069; 8,492,359; 8,822,668; 9,006,417; 9,504,651; 9,518,272; 11,141,378; 11,298,320; and 11,318,098 relating to…

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Biocon Completes Integration of Viatris Biosimilars Business

As we previously reported, in December 2022, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) had completed acquisition of the global biosimilars business of its long-term partner Viatris, Inc.  This week Biocon announced that it had “completed the integration of the acquired biosimilars business in over 70 countries in Emerging…

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