March 13, 2018 03:39, TOKYO — SanBio Group and Hitachi Chemical Co., Ltd. (Hitachi Chemical) jointly announced today that, through an agreement with Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS; formerly PCT Cell Therapy Services, LLC), Hitachi Chemical’s US subsidiary that engages in contract manufacturing and development of regenerative medicine products*1, they will manufacture SB623, a proprietary regenerative medicine product under development by SanBio. Under the agreement, late stage clinical products and commercial products of SB623 for the US and Japanese markets will be manufactured using Hitachi Chemical’s global facilities. [Read more…]
In major news released today, MiMedx Group announced that their AmnioFix® Injectable was awarded RMAT status by the U.S. FDA. This is the third RMAT designation awarded by the FDA this year and the 15th RMAT overall since the designation was introduced by the 21st Century Cures Act. The “Regenerative Medicine Advanced Therapy” (RMAT) Designation was introduced on December 13, 2016, when Congress included several provisions in the 21st Century Cures Act, an act signed into law by the 114th United States Congress authorizing $6.3 billion in funding, the bulk of which is allocated for programs supported by the National Institutes of Health (NIH).
The 21st Century Cures Act has had a profound effect on the regenerative medicine industry, supporting expansion of this industry to 600+ companies worldwide. The act also accompanies accelerated regulatory pathways that have been introduced in several other countries worldwide, including Japan, South Korea, and the E.U.
Within the U.S., sponsors of cell and gene therapies are eligible to obtain an RMAT designation if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it could address unmet medical needs. [Read more…]
Acquisition enables Astellas to fully utilize proprietary technology to produce pluripotent stem cells that have the potential to lower immunological rejection in numerous therapeutic areas
TOKYO, Feb. 13, 2018 — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Universal Cells, Inc. (CEO: Claudia Mitchell, “Universal Cells”) today announced that Astellas has acquired Universal Cells. Astellas will gain Universal Cells’ proprietary Universal Donor Cell technology to create cell therapy products that do not require Human Leukocyte Antigen (HLA) matching, potentially overcoming a huge treatment challenge by reducing the risk of rejection.
Americord Registry LLC Seeks Up To $6 Million In Funding To Fuel Its Rapidly Expanding Business
NEW YORK, Feb. 2, 2018 — Americord Registry LLC is seeking up to $6 million in funding to fuel its rapidly expanding business. Ranked for the past three years as one of the fastest growing private companies in the United States, Americord intends to use the additional funds to continue its history of innovation through the development and promotion of new stem cell collection technology and innovative new stem cell therapies. [Read more…]
Cytori developing cell therapies that harness the unique attributes of adipose-derived regenerative cells (ADRCs)
40 patients enrolled among 5 French centers: Marseille, Montpelier, Rouen, Lyon, and Paris
SAN DIEGO, Jan. 22, 2018 — Cytori Therapeutics, Inc. (NASDAQ:CYTX) announces completion of patient enrollment in SCLERADEC II (NCT02558543), a randomized, double-blind, placebo-controlled, parallel group, multi-center clinical trial intended to study the safety and efficacy of Habeo™ Cell Therapy in up to 40 subjects with impaired hand function due to scleroderma (systemic sclerosis). [Read more…]