Plexus Partners’ Post

New interactive guide: connect with curated products, services, and documentation for your biopharma workflow. Browse the QualTrak digital experience to learn about qPCR and dCPR workflows for monoclonal antibodies, vaccine development, and cell & gene therapies across biopharmaceutical development and manufacturing. To help streamline biologics development and simplify compliance, the QualTrak umbrella of product and services offers sensitive and reliable qPCR and dPCR tools for quantitative nucleic acid analysis. Explore recommended tools based your pipeline phase, use case, or application across a range of therapeutic modalities. https://bit.ly/3v0vXRj

New interactive guide: connect with curated products, services, and documentation for your biopharma workflow. Browse the QualTrak digital experience to learn about qPCR and dCPR workflows for monoclonal antibodies, vaccine development, and cell & gene therapies across biopharmaceutical development and manufacturing. To help streamline biologics development and simplify compliance, the QualTrak umbrella of product and services offers sensitive and reliable qPCR and dPCR tools for quantitative nucleic acid analysis. Explore recommended tools based your pipeline phase, use case, or application across a range of therapeutic modalities. https://bit.ly/3v0vXRj

New interactive guide: connect with curated products, services, and documentation for your biopharma workflow. Browse the QualTrak digital experience to learn about qPCR and dCPR workflows for monoclonal antibodies, vaccine development, and cell & gene therapies across biopharmaceutical development and manufacturing. To help streamline biologics development and simplify compliance, the QualTrak umbrella of product and services offers sensitive and reliable qPCR and dPCR tools for quantitative nucleic acid analysis. Explore recommended tools based your pipeline phase, use case, or application across a range of therapeutic modalities. https://bit.ly/3v0vXRj

New interactive guide: connect with curated products, services, and documentation for your biopharma workflow. Browse the QualTrak digital experience to learn about qPCR and dCPR workflows for monoclonal antibodies, vaccine development, and cell & gene therapies across biopharmaceutical development and manufacturing. To help streamline biologics development and simplify compliance, the QualTrak umbrella of product and services offers sensitive and reliable qPCR and dPCR tools for quantitative nucleic acid analysis. Explore recommended tools based your pipeline phase, use case, or application across a range of therapeutic modalities. https://bit.ly/3v0vXRj

Weekly market update: Here are some of the latest developments in the biotech and pharma industry: - AstraZeneca has acquired Fusion in a $2B radiopharma buyout. - Engrail, a neuropsych biotech, has closed a $157M series B funding round. - Bayer is set to take its menopause drug to regulators after winning its third phase 3 trial. - The FDA has blocked the approval of Regeneron's blood cancer drug. - AbbVie has acquired Landos Biopharma, with a focus on immunology. - Ferrer has offered $122M for the ex-US license to verge ALS drug. - Tenaya Therapeutics' gene therapy for an inherited heart condition that can cause sudden death appears to be effective in mice, according to new data. - The FDA has elevated the recall of 6.6M Vyaire bag value masks. - Abiomed, a J&J company, has seen a serious Impella recall linked to 49 deaths. - Parexel CEO is retiring and handing over the reins to Peyton Howell. Stay informed with the latest biotech and pharma news. #biotech #pharma #marketupdate

The BioPhorum Advanced Therapy Medicinal Products Phorum promised you a publication this week and, true to our word, the presentation 'Industry recommendations for phase appropriate approach for assay validation in cell and gene therapies (CGTs)' is now released! Another fantastic example of cross industry collaboration for the benefit of all! Thank you to the authors and contributors: Jenny Kim, R. Alan Llenado, Ph.D., Aparna Subramanian, Ph.D, Manjula Aysola, Kieron McIntyre, santoshkumar khatwani, Ying Li, PING CARLSON, Nasser Sadr, Katie Holton, Jeanette Young Astellas Pharma US, Dominic Hildebrand, Zhu Pirot Bayer, Jason Matthews, Stuart Beattie, Douglas Brown, Silke Wissing, Berangere Tissot, Srividya Ramanathan, Weihong Wang, Kamran Abbas, Dengyun (Daisy) Sun, Yan Zhao, Roland Pach, Michael Molony, Shashi Prajapati (Ph.D) and Anne-Sophie Cottard In this presentation, members provide their consolidated opinions and recommendations to promote alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common CGT modalities. The aim is to provide a faster, more efficient route to CGT product development that is compliant with regulatory standards. The presentation includes: - An overview of product and methods lifecycle, including analytical method bridging (with examples). - The regulatory landscape - guidelines associated with analytical methods development and validation. - Determining a phase-appropriate approach to assay validation, including recommendations for the scope of method qualification. - Future perspectives for cell and gene therapies. You can download a copy from the BioPhorum website here - https://lnkd.in/eMzEmsti #AAV, #rAAV, #CAR-T, #phaseappropriate, #assayvalidation Sarah Currie, PMP, Steven Wall, Kathleen O’Hagan, Evelyn Camon, Rachel Hodges, Christine Boswell, Simon Walker

Eder Therapeutics and xcube.bio have announced a strategic cooperation to facilitate the market entry and commercialization of biotech assets in Canada and Europe. The two companies will coordinate their offerings to biopharma innovators in their respective regions and leverage the numerous synergies that exist between the healthcare systems of Europe and Canada. The collaboration will specifically focus on product profiling, regulatory processes, Health Technology Assessment (HTA), and medical communication, and commercialization - ultimately benefiting patients and biopharma partners.   "Eder Therapeutics is thrilled to combine its unique depth in the Canadian market with the breadth of a European platform like xcube.bio. This partnership will enhance access to innovative treatments for Canadian patients, which is our ultimate goal," said Jared Rhines, CEO of Eder Therapeutics.   Pierre-Henri Belin, CEO of xcube.bio, stated, "xcube.bio, a European market-entry specialist, has found a valued like-minded partner in Eder Therapeutics. We look forward to expanding this cooperation to accelerate patient access and provide added value to our biopharma partners."   An initial phase of expert cooperation will begin with Eder Therapeutics' investigational gene therapy for Lipoprotein Lipase Deficiency.

Thoughts on this? >> Siren Biotechnology and Catalent Enter Partnership for Manufacturing of AAV Gene Therapies for Cancer - GlobeNewswire >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #competitivemarketing #healthcare #pharma #pharmaceutical #biotech

🌟 Exciting News in Biomedical Innovation 🌟 The FDA has just released a pivotal guidance document: "Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products." This comprehensive guidance is a game-changer for anyone involved in the development of CAR T cell therapies. 🔬 Key Highlights: Detailed recommendations on manufacturing, nonclinical, and clinical aspects. Applicability to other genetically modified lymphocyte products. Focus on advancing the safe and effective development of revolutionary CAR T cell therapies. 💡 Whether you're in industry or academia, this document is an essential read. It not only underscores the FDA's commitment to supporting innovative therapies but also provides a clear roadmap for advancing these transformative treatments. 🔗 For a deep dive into the full guidance, visit the FDA's website: https://lnkd.in/gKcF5jvj #Biotech #FDA #CARTCells #GeneTherapy #HealthcareInnovation

LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> Merck signs MoU with Indian CDMO; Scorpius delays public offering: Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Merck and Indian CDMO Aragen have signed a memorandum of understanding for the manufacturing and development of monoclonal antibodies, Merck said Friday. CDMO Scorpius is delaying its public offering that was previously announced in March, the company said Friday. Scorpius still intends to sell 12,500,000 shares at $1 apiece. NorthStar Medical Radioisotopes and Convergent Therapeutics are partnering to develop the radiopharma biotech’s lead asset, dubbed CONV01-α, which is being investigated for prostate cancer. NorthStar will manufacture CONV01-α, supply the isotope Ac-225 and help with R&D activities, according to a Tuesday release. Radiopharma company Blue Earth Therapeutics is expanding its manufacturing agreement with Austrian manufacturer Seibersdorf Laboratories, according to a Tuesday release. Seibersdorf will now also manufacture Blue Earth’s actinium-225-based radioligand therapy. Cell and gene therapy CDMO ViroCell Biologics has finished an oversubscribed investment round but did not disclose financial details. The raise will be used to help the company grow with increased demand for its viral vector manufacturing services, the company said Wednesday. Iceland-based biotech PLAIO has raised €4.3 million ($4.7 million) for its AI product designed to improve pharma supply chains, the company said Wednesday. Baxter is “urgently” recalling a batch of its heparin injection due to high levels of endotoxins, which can cause issues like toxic shock, organ failure and even death. The batch being recalled was distributed in the US to wholesalers and healthcare facilities between March 2023 and August 2023. #lucidquest #genetherapy #celltherapy