Thursday, January 7, 2021 Daily Archives

BMS cites Lonza plant inspection as factor in liso-cel’s ongoing delay

Lonza says observations made by the FDA at its Texas facility should not further hamper the already delayed approval of Bristol-Myers Squibb’s lymphoma CAR-T candidate liso-cel. Bristol-Myers Squibb (BMS) added lisocabtagene maraleucel (liso-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T‑cell targeting lymphoma, to its pipeline through its $74 billion acquisition of Celgene. Though a Biologics License Application (BLA) was submitted to the US Food and Drug Administration (FDA) in December 2019, COVID-19-related constraints pushed back regulatory inspections necessary for…

Fujifilm invests in third viral vector plant citing ‘surging’ demand

Fujifilm says surge in demand for viral vectors prompted decision to invest in third development and production plant. Fujifilm announced plans to invest $40 million to set up the new plant in in Watertown, Massachusetts last week. The Japanese conglomerate’s contract services unit – Fujifilm Diosynth Biotechnologies – will run the facility when it comes online. In a press statement the CDMO’s CEO Martin Meeson said, “We are strategically establishing this facility in the greater-Boston area where there is a…