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Faytuks Network @FaytuksNetwork BREAKING: The newly released Epstein files include photographs showing Bill Clinton with victims. 速報：新たに公開されたエプスタイン文書には、ビル・クリントンが被害者たちと一緒に写っている写真が含まれている。 https://x.com/FaytuksNetwork/status/2002129815751786749 午前6:32 · 2025年12月20日

Analyst conversations are starting to include a new ingredient in the employee experience (EX) stack: Agentic AI. Enterprises in North America are already piloting AI agents that answer questions, route tickets, and surface insights directly inside workplace platforms. Our featured Gartner content helps explain where this fits in the broader EX platform category. If you are planning 2026 investments, this is a good moment to see how EX platforms and Agentic AI will intersect.

21st Century Cures Act The 21st Century Cures Act was passed by the 114th U.S. Congress in December 2016. The act authorize $6.3 billion in funding, most of which is allocated for the National Institutes of Health (NIH). The bill, passed by both houses of Congress and signed into law by President Obama, puts the U.S. on the same playing field as other countries that support accelerated of innovative medicines. Other regions that have accelerated pathways include Japan, South Korea, and the EU. The bill encourages late-stage development in regenerative medicine, recognizing the field’s potential to address severe unmet medical needs. Congress included several provisions related to cell and gene therapies in the 21st Century Cures Act, the most important of which is the RMAT designation. RMAT Reviews by The FDA For more detail, the following is from the U.S. FDA: As described in Section 3033 of the 21st Century Cures Act, a drug is eligible for regenerative medicine advanced therapy (RMAT) designation if: The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations; The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition. こんな記事が5日ほど前に何故か偶然発表されてるぜ

What is an RMAT? RMAT is an acronym that stands for “Regenerative Medicine Advanced Therapy.” The designation was introduced in December 2016 as part of the 21st Century Cures Act. Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs. An RMAT submission request must be made in conjunction with an Investigational New Drug application (IND), either concurrently or as an amendment to an existing IND. By definition, an RMAT is an award from the U.S. FDA that allows for faster, more streamlined approvals of regenerative medicine products within the United States, such as cell and gene therapies, tissue engineering products, and combination products. RMAT designations make innovative products eligible for quicker development and review of a marketing application. An RMAT designation is similar to the breakthrough therapy designation that is available to drugs. Benefits of an RMAT include increased opportunities to meet with FDA officials, as well as early meetings to discuss potential surrogate or intermediate endpoints.

アサーシスの無念を晴らそうぜ https://bioinformant.com/rmat/ A Complete List of All Publicly Announced RMAT Designations (148) December 10, 2025 By Cade Hildreth To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded? BioLife Solutions The answer is that 148 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 368 requests and issued 184, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and half (50%) of RMAT applications get approved (184 approvals / 368 applications = 50.0%). Sartorius Additionally, 13 companies have earned two RMAT designations each. These include: 4DMT, Abeona Therapeutics, Adaptimmune, Athersys, Atsena Therapeutics, CARsgen Therapeutics, Cook MyoSite, Fate Therapeutics, Intellia Therapeutics, Ocugen, Orchard Therapeutics, Poseida Therapeutics, and Sangamo Therapeutics. Athersys – MultiStem for the treatment of Ischemic Stroke (10/05/17) Athersys – MultiStem for the treatment of Acute Respiratory Distress Syndrome (ARDS) (09/23/20)

NVIDIA CFO: $500 BLN IN BOOKINGS FOR BLACKWELL AND RUBIN AI CHIPS THROUGH 2026 DOES NOT INCLUDE "ANY OF THE WORK THAT WE'RE DOING RIGHT NOW, ON THE NEXT PART OF THE AGREEMENT WITH OPENAI"