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…]
What is the 21st Century Cures Act? | 21st Century Cures Act Summary
Passed December 13, 2016, the 21st Century Cures Act authorizes $6.3 billion in funding. It will support the development of innovative regenerative medicines, by providing substantial funding to the U.S. NIH and the FDA, among other groups.
21st Century Cures Act
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Cord Blood Market Research – Competitive Trends and Macro Landscape
To apply cord blood market research to business decisions, a thorough understanding of the marketplace is required. There are a number of emerging trends, perinatal tissue types, and cell expansion technologies that are affecting the marketplace, but to fully understand their impact, historical context must be introduced. The global cord blood industry came into existence in the early 1990’s with the formation of several leading cord blood banks in the USA, followed by the establishment of cord blood banks across the globe. The mid-2000s were a growth period for the U.S. cord blood market, but that trend has since subsided and the market in now in a phase of maturation and consolidation. [Read more…]
MiMedx’s AmnioFix® Injectable Awarded 15th RMAT Designation in the U.S.
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…]
PlumCare Announced Partnership With Cordlife and Additional Funding to Scale Operations
New agreement with Cordlife expands testing and monitoring service to eight new countries in Asia as company helps families make better decisions for their long term health
ALAMEDA, Calif., Feb. 28, 2018 — PlumCare, a DNA advisory service for families, today announced the company reached a partnership agreement with Cordlife Group Limited, a Singapore Exchange mainboard listed consumer healthcare company, as it expands access to the first-ever lifetime DNA testing and advisory service to help families take control of their health. To further support commercialization and access to its proprietary tests and services, PlumCare has secured an additional $750,000 in seed funding, with Steuart Ventures as the lead investor in this early stage financing round. [Read more…]
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