Cell therapy weekly: Washington stem cell clinics must post notice indicating FDA-unapproval
This week: Washington state protects citizens from unproven stem cell therapies, Astellas continues to grow their cell therapy division and Fujifilm-Takeda collaboration will treat heart failure.
The news highlights:
Washington State passes bill requiring ‘unproven’ stem cell clinics to post a warning
Astellas develops cell therapy business with new US$102.5 million acquisition of Universal Cells
FUJIFILM and Takeda to collaborate on iPSC-derived cardiomyocyte therapy
Washington State passes bill requiring ‘unproven’ stem cell clinics to post a warning
House Bill 2356 has passed the Washington state Legislature, required stem cell clinics to post a notice that their injection procedures are not FDA-approved. Following calls from the FDA for states to protect their citizens, Washington joins California and Florida as states that have proposed or passed bills requiring clinics to be more transparent to prospective patients.
Astellas develops cell therapy business with new US$102.5 million acquisition of Universal Cells
Japanese pharmaceutical giant Astellas Pharma (Tokyo, Japan) cements their place in the cell therapy market by acquiring technology company Universal Cells (WA, USA) following 4 months of collaboration. Universal Cells have devised “Universal Donor Cell technology” that utilizes gene editing to block stem cells producing specific human leukocyte antigen (HLA) molecules. Application of this technology could enable Astellas to produce ‘off-the-shelf’ cell therapies that can be administered to any patient without the need for HLA-matching.
“We have been very impressed with Universal Cells’ capabilities in cell therapy, including Universal Donor Cell technology, which led us to our initial collaboration and ultimately this acquisition,” commented Yoshihiko Hatanaka, President and CEO, Astellas. “This additional capability will further enable Astellas to develop potential innovative cell therapies for numerous diseases with high unmet medical needs.”
FUJIFILM and Takeda to collaborate on iPSC-derived cardiomyocyte therapy
FUJIFILM Corporation (Tokyo, Japan) and Takeda Pharmaceutical Company Ltd. (Osaka, Japan) have announced they will collaborate to develop induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapies to treat heart failure. The collaboration will combine Fujifilm and Takeda’s expertise in iPSC-related technology, and pre-clinical and clinical studies.
“We are delighted to initiate this partnership applying practical use of our iPSC-derived cardiac cells with Takeda, which has abundant experience in drug development and clinical trials,” explained Aiichiro Hiruma, General Manager of Regenerative Medicine Division at FUJIFILM Corporation. “In addition to establishing new treatment methods for patients with heart disease, Fujifilm and Takeda will contribute to the elevation of regenerative medication business to the industrial stage by applying our engineering technologies to manufacture high-quality cells safely and efficiently.”
For more weekly cell therapy news, read previous editions of the cell therapy weekly.