Phase 3 data for efanesoctocog alfa has been published in the New England Journal of Medicine (NEJM): ahead of a decision on the therapy by the US Food and Drug Administration (FDA) at the end of next month.
Finch Therapeutics announced its shock decision to discontinue the PRISM4 Phase 3 trial of CP101 in recurrent C. difficile infection (CDI) yesterday (Jan 25) saying instead it will focus on ‘realizing the value of its intellectual property estate and...
Despite an uncertain macroeconomic environment, Lonza says its ‘resilient’ business model and sustained market demand delivered a strong financial performance in 2022, in line with the Swizterland based CDMO’s outlook.
In the US, 2022 heralded the next chapter for biosimilars, including US FDA approval of in new therapeutic areas, additional interchangeable designations, and litigation relating to biosimilars of more recent biologics.
Charles River Laboratories International, Inc and Rznomics Inc, a South Korea-based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, have established a viral vector contract development and manufacturing organization...
Biotech company, Vaxxas, has secured a partnership agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of its needle-free vaccine-patch delivery technology for mRNA vaccines.
The unprecedented rise in approvals for new cell and gene therapies, and the increasing industry need for cell lines to support the production of therapeutics, has spurred US CDMO, the Center for Breakthrough Medicines (CBM), to act
The European Medicines Agency (EMA) is planning to alert healthcare professions about liver failure cases linked to Zolgensma, a gene therapy against spinal muscular atrophy (SMA), which is developed by Novartis.
Lumen Bioscience has been highlighting recent progress made on its clinical and regulatory journey while also announcing several funding milestones supporting the development of its therapeutics to prevent serious diarrheal diseases.
German mRNA pioneer BioNTech will acquire InstaDeep, an artificial intelligence and machine learning specialist, for around £362m ($439m): pledging to incorporate rapidly evolving AI capabilities into its research, drug discovery, manufacturing and deployment...
Moderna and CytomX Therapeutics have announced a collaboration and licensing agreement to create investigational mRNA-based conditionally activated therapies using Moderna's mRNA technologies and CytomX's Probody therapeutic platform.
BioNTech and the UK government have signed a wide-reaching Memorandum of Understanding (MoU): with one of the goals to provide up to 10,000 patients with personalized mRNA cancer immunotherapies by 2030.