Novartis’s Kymriah CAR-T therapy did not meet its primary endpoint of event-free survival in a phase 3 study in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) after relapse or lack of response to first-line treatment.
VIVEbiotech, a lentivirus-specialized contract development and manufacturing organization (CDMO) that produces vectors for projects from early-stage to GMP production, is working on enhancing intrinsic lentivirus characteristics and streamlining the process....
The success of mRNA vaccine technology could be one of the new opportunities for US pharmaceutical manufacturing looking forward, with pandemic investments helping turbocharge the sector.
A new UK eLearning program is targeted at healthcare and academic professionals to support their learning on advanced therapy medicinal products (ATMPs).
Generate Life Sciences is establishing a GMP facility in La Jolla, California that it says will enable end-to-end manufacturing of newborn stem cell biologics, bolstering supply and safeguarding clinical research.
Bluebird’s Lenti-D, or elivaldogene autotemcel, has won approval from the European Commission to treat children with a rare neurodegenerative disease called early cerebral adrenoleukodystrophy (CALD).
Boston headquartered biotherapeutics company, GentiBio, Inc, and CGT focused CDMO, Forge Biologics, have set up a development and manufacturing partnership.
Cell therapy player, Bone Therapeutics, has secured up to €16m (US$18.9m) in a financing loan from the European Investment Bank (EIB) to accelerate ongoing clinical and commercial development of innovative orthopedic treatments.
Bayer owned CDMO, Viralgen, has expanded its AAV vector manufacturing capabilities in San Sebastian, in the Basque region of Spain, with the opening last week of a new site.
Biotech, Mogrify, recently closed a Series A financing of US$17m, bringing the total raised to US$33m in the round, with the investment set to support the advancement of the company’s immuno-oncology and ophthalmology programs.
Cobra Biologics, the gene therapy division of the Charles River owned Cognate BioServices, and Sweden's CombiGene recently announced the successful production and quality assurance of the plasmids to be used in the GMP production of the gene therapy,...
The partners announce the addition of a manufacturing facility that will become the fourth in Legend’s network. It is expected to be operational by 2023.
Genezen Laboratories, Inc, a US cell and gene therapy contract development and manufacturing Organization (CDMO) is set to build a 75,000+ square foot cGMP-compliant lentiviral vector production facility in Indianapolis.
Catalent is to acquire German company, RheinCell Therapeutics, a developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs) for the next generation of cell therapies.
Coriolis Pharma has announced a 7,800-meter-square expansion to a building situated in Munich, Germany, where the company is headquartered, that will host formulation development for advanced therapeutic medicine products (ATMPs).
Sorrento Technologies, a biotech firm developing novel treatments for COVID-19 and aggressive cancers such as melanoma, has received FDA clearance to start a research collaboration together with Mayo Clinic.
In recent years, it has become clear that RNA molecules are an emerging as a class of therapeutics of relevance to multiple diseases, most recently including COVID-19 vaccines.
The World Health Organization (WHO), as part of its International Nonproprietary Names (INN) system, has recently made progress in developing and harmonizing the definition paragraphs that support the naming of cell-based substances.
The FDA has lifted the clinical holds on bluebird bio’s trials of gene therapies in sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT), an inherited blood disorder.
A robust research and innovation ecosystem makes Italy an attractive life sciences hotspot, according to a post from an Italian trade delegation at Bio Digital 2021.
Univercells Technologies’ scale-x carbo bioreactor is to be used at the National Institute of Bioprocessing Research and Training (NIBRT) in Dublin, Ireland.
Gamma Biosciences has taken a controlling investment in Mirus Bio, an innovator and developer of biomimetic, cell-adaptive lipid-polymer nanocomplexes (LPNCs) for nucleic acid delivery based in Wisconsin in the US.
Thermo Fisher Scientific Inc and the University of California, San Francisco (UCSF) have formed a alliance to accelerate the development and manufacturing of cell-based therapies.
Protalix BioTherapeutics is planning to propose a virtual or record review inspection to clear the barrier to approval of its Chiesi Farmaceutici-partnered Fabry disease treatment.
Charles River Laboratories International Inc is to acquire US based Vigene Biosciences, a cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) providing viral vector-based gene delivery solutions for research and clinical...
Many turn to Boston and North Carolina’s Research Triangle to set up life science companies, but Chicago is now also fast becoming a draw in this respect. The city is emerging as a life science and biopharma hub and seems poised for even further growth,...
Charles River says the combination of Distributed Bio’s platform, which the CRO recently acquired, with its own downstream characterization capabilities, enables identification of the best lead candidate in CAR T cell therapies – balancing efficacy and...
US contract research organization, PPD Inc, is expanding its Athlone, Ireland, GMP laboratory, significantly increasing the size of its current facility and adding cell and gene therapy (CGT) testing to the operation’s portfolio of services.
Takara Bio Europe has announced a licensing agreement with Denmark’s PanCryos, a pre-clinical stage biotech company, for its clinical-grade human embryonic stem (hES) cell lines, starting material for cell therapy development.
Last month saw ATMPS Ltd, a developer of blockchain-based cell orchestration platforms for advanced therapies, and Ori Biotech, an innovator in cell and gene therapy (CGT) manufacturing platforms, come together in an alliance aimed at creating seamless...
Contract development and manufacturing organization, Catalent, has invested in the capabilities at its clinical supply services facility in Philadelphia, in the US, to further support biotech firms developing cell and gene therapies.
