The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option.
Allergan will expand its existing facilities in Ireland through an investment of €65m to produce new product formats for existing and investigational products.
Novartis investigates the death of an infant in a gene therapy clinical trial to determine whether it was related to the treatment but does not anticipate an impact on FDA approval.
US FDA grants orphan drug designation for Hyleukin-7, an immuno-oncology agent that boosts T cell production and functionality, for the treatment of ICL.
The expanding cell therapy market has placed new demands on supply chain services, with their shipment requirements and competition in the logistics industry rising.
I-Mab and WuXi Biologics extend their strategic partnership for biologics process development as well as clinical and commercial manufacturing to accelerate drug development in China and abroad.
Bringing together the food industry’s know-how and pharma’s manufacturing expertise, the new joint venture from Lonza and Chr. Hansen is positioned to pioneer the live biotherapeutic products space – addressing medical needs not met with ‘conventional’...
GE Healthcare partners with Rockwell to improve bioprocessing automation operations, which could reduce review time of batch files and processes by weeks.
Aji Bio-Pharma will add a flexible fill line, packaging and labelling equipment to its worldwide manufacturing network, in an investment worth upwards of $100m.
Abzena and Lipum enter agreement for the development of biologics for juvenile idiopathic arthritis, using the former’s proprietary cell line and GMP resources.
The market for cell therapy products is set to expand based on increasing investment from the industry and the implementation of advanced manufacturing technologies.
The global cell line development market grows steadily with a predicted revenue of $7.5bn by 2024, each component of the market to see CAGR between 10-15%.
ABL will use WuXi’s platforms in an extended agreement for the development and commercialization of its bispecific antibodies, using the recently launched WuXiBody platform.
In addition to the $55m previously invested, Novartis will spend a further $60m in expanding AveXis’ site in North Carolina enabling the manufacture of multiple gene therapies simultaneously.
The WHO establishes a multi-disciplinary committee to advise on the ethical and scientific challenges of human genome editing, as the technology’s capability and utilization grows in the industry.
Oxford Genetics and Sphere Fluidics to partner, alongside additional biopharma organizations, to develop automated systems for high-throughput gene editing in mammalian cell lines.
AbbVie and Teneobio enter an agreement to develop and commercialize an immunotherapeutic for the treatment of multiple myeloma using the latter’s proprietary anti-CD3 platform.
ICT is developing upon CAR-T cell technology to enable T-cells to persist against cancer’s attempt to program death into a patient’s defensive T-cells, which could potentially treat solid tumors.