Search Results for: mimedx

Stem cell news July 2018: RMATs, RTT, MiMedx mess, clinic family ties & more

Bob-Comella-U.S.-Stem-

The year of 2018 has already been a wild one for stem cell news. There are many developments on a variety of fronts. Here are some of the most notable news bites of the last month or so. RMAT Wave. The FDA continues its warp-speed issuance of Regenerative Medicine Advanced Therapy (RMAT) designations with 20 …

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Tom Price & MiMedx: a stem cell connection?

Tom-Price-HHS-Senate

What’s the deal with Trump’s HHS Secretary pick Rep. Tom Price (now testifying before the Senate) and the amniotic tissue/stem cell company MiMedx that’s caused some buzz in the last 48 hours? I’ve been following MiMedx for a few years since it received an untitled letter from the FDA and I noted its claim of one its …

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MiMedx (MDXG) placental “stem cell magnet” drugs attract FDA attention and lawsuit

ABC News just reported that the FDA is allgedly “cracking down” on the publicly traded company, MiMedx (MDXG), which sells a placental derivative touted for healing powers. The Wall Street Journal is also following the story. According to ABC News: MiMedx is a publically traded, for-profit company that takes donated human placentas — solicited via a website featuring …

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FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36

Peter-Marks-Regenerative-Medicine-Advanced-Therapy-Designation-RMAT-

This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm …

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3X recent stem cell & regenerative medicine good news

Stem cells spina bifida

In the past month or two there has been a steady stream of good news in the stem cell and regenerative medicine world. Here are three examples. Fate Therapeutics announced the first US IND for an induced pluripotent stem cell (IPSC)-related product. Its cleared product, FT500, is an off-the-shelf natural killer-based cancer immunotherapy. I expect …

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RMAT List (54)

FDA-RMAT

Today’s post includes a list of firms/products that have self-reported that they have received FDA regenerative medicine advanced therapy designation or RMAT. As of October 5, 2021 54 RMATs are in the public domain. I also include FDA data on RMAT submissions via an FDA RMAT resource page. I’m assuming for the purposes of this …

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REGROW Act, Mark Kirk Lobbying & Contributions Yield Stem Cell Surprises

Center-for-Responsive-Politics

The money behind a piece of legislation can provide unique insights into the back story and this is definitely true for the REGROW Act that would reduce FDA oversight of the investigational use of stem cells in patients. Senator Mark Kirk of Illinois, who is facing probable defeat next week in his reelection bid according to …

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FDA meeting on stem cell regs: mostly who’s who of anti-regulation forces

FDAADF

The FDA in the past year or so has issued draft guidances on regulation of stem cells that would, if finalized, make it crystal clear that what many American stem cell clinics are selling are unapproved drugs. That would be a good thing for patients who are often being put at risk by many of …

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