News Headlines

31. NorthX Biologics Achieves Milestone GMP Certification To Manufacture Vididencel 12/1/2025

    NorthX Biologics, a leading CDMO and Swedish national innovation hub for advanced biologics, and Mendus (publ: IMMU.ST), a Swedish-Dutch immuno-oncology company developing cell-based immunotherapies to address tumor recurrence and improve survival outcomes, today announced the successful completion of GMP manufacturing certification for Mendus’ lead cell therapy product, vididencel.

32. Infant Bacterial Therapeutics AB Secures Partnership With Recipharm Advanced Bio For Commercial Production Of Drug Substance 12/1/2025

    Recipharm Advanced Bio, a segment of Recipharm and a leading Contract Development and Manufacturing Organisation (CDMO), and Infant Bacterial Therapeutics AB (IBT), announced the initiation of Process Performance Qualification (PPQ) for IBT's lead product, IBP-9414.

33. Regeneron And Tessera Therapeutics To Jointly Develop TSRA-196, An Investigational Gene Editing Therapy For Alpha-1 Antitrypsin Deficiency (AATD) 12/1/2025

    Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Tessera Therapeutics, Inc., today announced a global collaboration to develop and commercialize TSRA-196, Tessera’s lead investigational in vivo Gene Writing program for the treatment of alpha-1 antitrypsin deficiency (AATD), an inherited monogenic disease that can affect the lungs, liver, or both organs, and currently impacts approximately 200,000 people in the U.S. and Europe.

34. BioDlink Showcases Europe-China CMC Collaboration Amid Developmental Breakthrough 11/28/2025

    BioDlink, a global leader in biologics contract development and manufacturing, took center stage at Biologics CDMO Europe 2025 to present its critical role in the regulatory approval and manufacturing support of the world's first approved EGFR-targeted antibody-drug conjugate (ADC) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC).

35. Avalon Pharma Signs MoU With Benta To Advance Innovative And Specialized Pharmaceutical Manufacturing In Saudi Arabia 11/27/2025

    Avalon Pharma is proud to announce the signing of a Memorandum of Understanding (MoU) with Benta, a global leader in pharmaceutical manufacturing and biotechnologies.

36. eXmoor Pharma And Royal Free London Launch Strategic Collaboration To Strengthen UK Cell And Gene Therapy Manufacturing Pathway 11/26/2025

    eXmoor Pharma, the integrated cell and gene therapy CDMO with embedded consultancy expertise, and Royal Free London NHS Foundation Trust, through its Cell and Vector Innovation Centre (CVIC), have entered a strategic collaboration to build a seamless, scalable pathway for cell and gene therapy development and manufacturing in the UK.

37. Prestige Biopharma And Biosidus Enter Exclusive License Agreement For Tuznue® Commercialization In Latin America 11/26/2025

    Prestige Biopharma, a biopharmaceutical company specializing in antibody therapeutics, today announced an exclusive license and supply agreement with Biosidus, a biotechnology company headquartered in Buenos Aires, Argentina, with decades of experience in biosimilar development and commercialization, for the commercialization of Tuznue® (trastuzumab) across Latin American markets, including Argentina, Mexico, Bolivia, and Paraguay.

38. Zydus And RK Pharma Enter Into An Exclusive Licensing And Commercialization Agreement For A Novel 505(b)(2) Product Of Supportive Oncology Treatment For The USA Market 11/26/2025

    Zydus Lifesciences Ltd. (including its subsidiaries and affiliates), a global innovation-driven healthcare company, today announced that it has entered into an exclusive licensing and commercialization agreement with RK Pharma Inc of the US for a novel sterile injectable 505(b)(2) oncology supportive care product for the US market.

39. Algorithm And Batterjee Pharma Sign Strategic Partnership Agreement To Localize Key Pharmaceuticals In KSA 11/25/2025

    Algorithm, a pioneering regional pharmaceutical manufacturer has announced the signing of a strategic partnership agreement with Batterjee Pharma, a leading Saudi pharmaceutical company, becoming the first Lebanese company to localize its portfolio in the Kingdom.

40. Scaleready Grant To Fuel Development Of Innovative Cancer Treatments At The Ottawa Hospital's Biotherapeutics Manufacturing Centre 11/25/2025

    ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation and CellReady, announced today that the Biotherapeutics Manufacturing Centre (BMC) at The Ottawa Hospital’s Research Institute (OHRI) has been awarded a $300,000 USD G-Rex Grant.