Cell therapy weekly: Acting FDA Commissioner named as Ned Sharpless
This week: Fujifilm to acquire Biogen manufacturing site and new phase II trial will pit stem cells against MS
The news highlights:
Scott Gottlieb’s surprising resignation last week, Ned Sharpless, the director of the National Cancer Institute (NCI; MD, USA), has been named as acting commissioner of FDA. A career scientist, Sharpless also ran the Lineberger Comprehensive Cancer Center at the University of North Carolina (NC, USA) before taking over the NCI in October 2017. It’s not yet clear whether Ned will take over running of FDA in the longer-term.
Fujifilm Corporation (Tokyo, Japan) has announced it has agreed to acquire Biogen Manufacturing ApS (Hillerød, Denmark) for approximately US$890 million. The move will bolster Fujifilm’s growing CDMO business, with 800 new employees and 6 x 15,000L bioreactors, allowing them to offer ‘scale up’ services in addition to ‘scale out’. Upon completion, this facility will be Fujifilm’s fourth biopharmaceutical contract development and manufacturing site.
At Fujifilm, our goal has always been to bring new value to society, through innovation and the creation of new technologies, products and services.” said Shigetaka Komori, chairman and chief executive officer of FUJIFILM Corporation. “This significant investment demonstrates our continued commitment to grow the Bio CDMO Business and become an industry leader by combining resources of Biogen and Fujifilm.”
A phase II clinical trial pitting stem cells against multiple sclerosis (MS) will involve 50 people with progressive MS and is being funded by US$1 million from the National MS Society (NY, USA). In the trial, allogeneic bone-marrow derived mesenchymal stem cells will be differentiated into neural progenitors and infused into the spinal fluid. A previous phase I trial demonstrated safety, with efficacy in changing measures of disability the key endpoints in this latest trial.
“There is an urgent need for more effective treatments for MS, particularly for those with more progressive forms of the disease,” said Bruce Bebo, National MS Society Executive Vice President, Research. “We believe that the potential of all types of cell therapies must be explored, and we are pleased to be a part of this clinical trial.”
For more weekly cell therapy news, read previous editions of the cell therapy weekly.