News Headlines

  1. Zydus And Synthon Entered Into Exclusive Licensing And Supply Agreement For Ozanimod Capsules (Generic Version Of ZEPOSIA®) For The U.S. Market 9/4/2025

    Zydus Lifesciences Ltd. (including its subsidiaries and affiliates), a global innovation-driven healthcare company, today announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, has entered into an exclusive licensing and supply agreement with Synthon BV of the Netherlands for Ozanimod Capsules (a generic version of ZEPOSIA®) for the U.S. market. Synthon has a pending abbreviated new drug application in the United States, seeking approval for Ozanimod Capsules indicated for relapsing forms of multiple sclerosis.

  2. Grünenthal PRO Is Joining SHL Medical's Alliance Partnership Network To Offer Final Assembly Service For Molly® Autoinjectors 9/4/2025

    Grünenthal PRO, the contract development and manufacturing organization (CDMO) division of Grünenthal offering a range of services including final assembly of autoinjectors, is entering into a non-exclusive partnership with SHL Medical, a world-leading solutions provider of advanced drug delivery systems. Through this collaboration, Grünenthal PRO will offer final assembly, packaging and labelling of Molly® autoinjector.

  3. Herma US To Exhibit Robotic Labeling Cell And Front/Back/Wrap Labeling Systems At Pack Expo 2025 9/3/2025
  4. Andelyn Biosciences And Tern Therapeutics Partner For Late-Stage Process Performance Qualification (PPQ) Manufacturing Of AAV Gene Therapy For The Treatment Of CLN2 Batten Disease 9/3/2025

    Andelyn Biosciences, Inc., a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has partnered with Tern Therapeutics (Tern) to perform late-stage Process Performance Qualification (PPQ) manufacturing of Tern's TTX-381 program.

  5. BioFactura Launches Capitol Biologics - New CDMO Division To Accelerate Biologics Development From Concept To Clinic 9/3/2025

    BioFactura, Inc., a clinical‑stage biopharmaceutical company specializing in high‑value biosimilars and critical biodefense medical countermeasures, today announced the formation of Capitol Biologics, a new Contract Development and Manufacturing Organization (CDMO) division dedicated to supporting the process development, early‑phase clinical manufacturing, and analytical needs of emerging biotechnology companies and U.S. government agencies.

  6. Charles River Enhances Cell Therapy Flex Platform Through Collaboration With Akadeum Life Sciences 9/3/2025

    Charles River Laboratories International, Inc. and Akadeum Life Sciences, a leader in advanced cell separation technologies, announced today the integration of Akadeum’s GMP-grade Human T Cell Leukopak Isolation Kit into Charles River’s Cell Therapy Flex Program.

  7. Cytovance Biologics Expands Services With In-House Formulation Development 9/3/2025

    Cytovance Biologics, a U.S.-based Contract Development and Manufacturing Organization (CDMO), announced the launch of its in-house formulation development services, significantly expanding its service offerings to biotech and pharmaceutical clients. This strategic enhancement reinforces the company’s position as a full-service partner for biologic drug developers.

  8. Ori Biotech's IRO Platform Receives FDA Advanced Manufacturing Technology (AMT) Designation 9/3/2025

    Ori Biotech, a leader in cell and gene therapy (CGT) manufacturing technology, today announced that the IRO platform has received Advanced Manufacturing Technology (AMT) designation from the U.S. Food and Drug Administration (FDA).

  9. CDMO Grand River Aseptic Manufacturing Announces Denis Johnson As New CEO 9/2/2025

    Grand River Aseptic Manufacturing (“GRAM” or the “Company”), a portfolio company of Arlington Capital Partners, today announced the promotion of Denis Johnson to Chief Executive Officer, effective September 1, 2025. Mr. Johnson has served as President of GRAM since March 31, 2025.

  10. Polpharma Biologics And MS Pharma Sign Licensing Agreements For Proposed Vedolizumab (PB016), Ocrelizumab (PB018) And Guselkumab (PB019) Biosimilars 9/2/2025

    Polpharma Biologics S.A. (“Polpharma Biologics”), specialized in the development and manufacturing of biosimilars, today announced that it has signed licensing agreements with MS Pharma, a leading biosimilar production and distribution company in the Middle East and North Africa (MENA) region, for the commercialization of its biosimilar candidates vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) in the MENA region.