CASI Pharmaceuticals and Juventas Cell Therapy recently received approval from China's National Medical Products Administration (NMPA) for Yuanruida, a domestic CD19-targeting CAR-T therapy for relapsed/refractory B-Cell Acute Lymphocytic Leukemia.
Gilead Sciences has decided to end a phase 3 trial of magrolimab for higher-risk myelodysplastic syndromes (MDS) after an analysis suggested it would be futile to continue.
Gilead’s CAR-T therapy Yescarta (Axicabtagene ciloleucel) has been recommended for routine use on the National Health Service (NHS) in England for patients with an aggressive form of lymphoma.
The US Food and Drug Administration (FDA) has approved Kite’s retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production.
The antibody drug conjugate market has had a busy few years, as the appetite for acquisitions of ADC-specialists began to grow, with Gilead buying Immunomedics and Merck acquiring VelosBio.
The European Commission (EC) has approved Kite’s CAR T-cell therapy, Yescarta, (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
The Biotechnology Innovation Organization elected the fresh slate of leaders during the BIO International Convention, taking place in San Diego this week.
Kite, a Gilead company, says the US Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland.
The US FDA has approved Yescarta, Kite's CAR-T cell therapy, for initial treatment in adults with large B-cell lymphoma (LBCL) that is refractory to one prior therapy or that relapses within 12 months of first-line chemoimmunotherapy.
Kyverna Therapeutics, a cell therapy company engineering a new class of therapies for autoimmune diseases, has closed an oversubscribed $85m Series B financing round led by Northpond Ventures.
Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), has acquired ADC Biotechnology (ADC Bio), a UK based company specializing in antibody-drug conjugates (ADCs).
Vineti’s latest financing round sees Novartis and Gilead join forces to invest in technology platform that enables scale-up of CAR Ts and allogeneic cell therapies.
Gilead’s continued investment in cell therapy manufacturing capabilities, at a time when sales at the nascent business unit are flatlining, was called into question by investors.
As we have entered the summer, companies have taken to refreshing their leadership positions, including at companies such as Gilead, Alnylam, and Maze Therapeutics.
BMS’ capture of Celgene caught much attention, due to the size and scale of the acqusition, but rival companies have taken the chance to snap up employees that have left after the deal.
This month’s round-up of the most popular stories of the month, featuring a bold prediction of future growth for Chinese biotech and bad news for a potential treatment for Alzheimer’s disease.
As we enter spring, several companies have refreshed the look of their executive boards – some to strengthen their direction and some out of necessity.
The difficulties in the manufacture of CAR-T treatments have become increasingly understood as the breakthrough technology has been commercialised, but Kite’s head of medical affairs says its process is nearly flawless.
MaxCyte announces a partnership with Kite to explore the use of flow electroporation technology to enable the non-viral cell engineering of CAR-T drug candidates.
The market for cell therapy products is set to expand based on increasing investment from the industry and the implementation of advanced manufacturing technologies.
With nearly 300 cell and gene therapies in development, targeting more than 100 diseases, 2019 could be set to be a big year for cell and gene therapies.
Securing the clinical supply chain comes down to the notion of ‘compliance’, which is transitioning from a ‘nice to have’ to a ‘need to have,’ says Cryoport.
Novartis’ experimental marketing strategy, whereby the pharma giant used its scale to insure against failed CAR-T therapies, helped defend Kymriah from competition, says consultant.
The US FDA has released draft guidance documents on gene therapy programmes, which “should help sponsors avoid expending time and resources on unproductive drug development efforts,” says expert.
