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 …
Stem cell news July 2018: RMATs, RTT, MiMedx mess, clinic family ties & more Read More »
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 …
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 …
MiMedx (MDXG) placental “stem cell magnet” drugs attract FDA attention and lawsuit Read More »
If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in …
End of FDA “grace period” impacted perinatal cell therapy biotechs Read More »
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 …
FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36 Read More »
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 …
3X recent stem cell & regenerative medicine good news Read More »
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. Sometimes people call these “r mat” with a space. As of April 24, 2023 there are 71 RMATs in the public domain. I also include FDA data on RMAT submissions via an FDA RMAT resource …
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 …
REGROW Act, Mark Kirk Lobbying & Contributions Yield Stem Cell Surprises Read More »
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 …
FDA meeting on stem cell regs: mostly who’s who of anti-regulation forces Read More »