Category: Medicine

  • Kincell Bio to Acquire Imugene’s North Carolina Manufacturing Facility

    Kincell Bio to Acquire Imugene’s North Carolina Manufacturing Facility

    Imugene have announced a strategic manufacturing and process development partnership, which includes the sale of Imugene’s North Carolina Current Good Manufacturing Practice (CGMP) manufacturing facility and the transfer of process and analytical development activities to Kincell. Under the terms of an asset purchase agreement between Imugene and Kincell, Kincell will acquire Imugene’s CGMP compliant cell therapy…

  • AGC Biologics to Collaborate with Cytiva in Japan

    AGC Biologics to Collaborate with Cytiva in Japan

    AGC Biologics, in collaboration with the global life sciences leader Cytiva, is set to innovate its production line at its new facility in Yokohama, Japan with two FlexFactory manufacturing platforms.  Situated in a globally accessible area within the Asia Pacific region, the new manufacturing site is expected to significantly contribute to the needs of regional…

  • Aptamer and Kairos Biotech to Partner

    Aptamer and Kairos Biotech to Partner

    Aptamer Group, the developer of novel Optimer binders to enable innovation in the life sciences industry, have announced the progression of a partnership with Kairos Biotech, an early-stage company developing novel therapeutic solutions for transplant rejection. As part of this agreement, Kairos Biotech will leverage Aptamer’s new Optimer+ affinity ligand platform in development of their pipeline of…

  • FDA Approves Roche’s Alecensa – European Pharmaceutical Manufacturer

    FDA Approves Roche’s Alecensa – European Pharmaceutical Manufacturer

    Roche have announced that the U.S. Food and Drug Administration (FDA) has approved Alecensa (alectinib) for adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumours ≥ 4 cm or node positive), as detected by an FDA-approved test. Alecensa is now the first and only ALK inhibitor approved…

  • Ferring Pharmaceuticals and SK Pharmteco to Partner

    Ferring Pharmaceuticals and SK Pharmteco to Partner

    Ferring Pharmaceuticals and SK pharmteco have announced an agreement to scale up commercial manufacturing capacity for the drug substance of Ferring’s intravesical gene therapy Adstiladrin (nadofaragene firadenovec-vncg) for ensuring long-term future supply. Following technology transfer, SK pharmteco, a contract development manufacturing organisation (CDMO), will be qualified as another source for manufacturing, testing, and release of the medicine,…

  • GSK’s Meningococcal Vaccine Approved for Regulatory Review

    GSK’s Meningococcal Vaccine Approved for Regulatory Review

    GSK have announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. The Prescription Drug User Fee Act (PDUFA) action date for a regulatory decision by the US FDA on this application is 14 February 2025. GSK’s 5-in-1 MenABCWY vaccine…

  • Q&A: Renaissance Lakewood – European Pharmaceutical Manufacturer

    Q&A: Renaissance Lakewood – European Pharmaceutical Manufacturer

    In an interview with Jai McIntosh, Editor for EPM, Eric Kaneps, VP, Sales and Marketing at Renaissance Lakewood explores how innovation has been at the heart of the success of the company and the market. He also provides his unique insights into some of the challenges nasal spray developers are currently facing. Jai: How would you…

  • Veeva Launches AI Partner Program

    Veeva Launches AI Partner Program

    Veeva Systems have announced the Veeva AI Partner Program to provide partners with the advanced technology and support needed to integrate Generative AI (GenAI) solutions seamlessly with Veeva Vault applications. “Our customers are exploring GenAI solutions across many use cases as the technology evolves,” said Tom Schwenger, Veeva president and chief customer officer. “The Veeva AI Partner Program provides access…

  • Ardena’s Nanomedicines Facility Marks €20 Million Expansion

    Ardena’s Nanomedicines Facility Marks €20 Million Expansion

    Ardena has received Good Manufacturing Practice (GMP) approval from the Dutch Healthcare Authority for its new analytical laboratories in its expanded nanomedicines facility. The facility includes state-of-the-art GMP-compliant cleanrooms to support Ardena’s growing nanomedicines business, as well as laboratories for process development and analytical work, GMP production space, and warehouse facilities. Harry Christiaens, CEO of Ardena,…

  • Ozempic Not Linked with Suicidal Thoughts Finds EMA

    Ozempic Not Linked with Suicidal Thoughts Finds EMA

    Recently, the European Medicines Agency (EMA)’s drug safety committee, PRAC, evaluated and analysed the potential risk of side effects in individuals who have used the GLP-1 class of drugs. This follows reports last June that individuals in Iceland reported experiencing bouts of suicidal and/or self-harm thoughts, nausea, vomiting, etc.  The PRAC has concluded that the available evidence…