Tagged as: Catalent

Scheduling Order Issued in REGENXBIO v. Sarepta Litigation

As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware in June 2023 against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging infringement of U.S. Patent No. 11,680,274 by Sarepta’s gene therapy product, ELEVIDYS (delandistrogene moxeparvovec-rokl).  Sarepta and Catalent each…

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Sarepta and Catalent File Answers in REGENXBIO v. Sarepta Litigation

As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging infringement of U.S. Patent No. 11,680,274 by Sarepta’s gene therapy product. Sarepta’s gene therapy product, SRP-9001, was approved this June…

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REGENXBIO Sues Sarepta Therapeutics for Patent Infringement on Gene Therapy Product

Last week REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging that the defendants’ adeno-associated virus (“AAV”) technology gene therapy product has infringed or will infringe U.S. Patent No. 11,680,274 (“the ‘274 Patent”)….

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Expanding Operations in Biologics

Catalent and Abzena both recently announced substantial investments into new biologics facilities.  Catalent is spending up to $160 million to build a new manufacturing facility near Oxford, UK.  Catalent plans to equip the facility with “state-of-the-art capabilities for the development and manufacture of biologic therapies and vaccines, including mRNA, proteins…

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Deal Watch: Catalent Biologics and Valerius Biopharma to Collaborate on Manufacture of Specialty Biosimilar Products

Earlier this week, Catalent Pharma Solutions and Valerius Biopharma AG jointly announced their collaboration on the manufacture of Valerius’ specialty biosimilar products.  According to the press release, Catalent Biologics will provide cell line development and support cGMP manufacturing activities from Phase I through to commercial stages.  The collaboration will additionally…

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