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 »
I’m fascinated by the idea of making food from cells grown in a lab and especially the newest idea of lab-grown chocolate. While lab-grown meat has gotten the most attention, (see my recent post on test-tube meat: Not Old MacDonald’s Farm: is the future lab-grown meat?) I’d say that the coolest application of making food from
Biotech California Cultured aims to sell lab-grown chocolate Read More »
Trying to make a CRISPR baby any time soon would be a really bad idea. How bad? Last December 3rd I penned a piece for STAT News arguing for a moratorium on the heritable use of CRISPR in humans. This potential future, radical application of “gene editing” is now often colloquially referred to as “CRISPR
CRISPR baby moratorium grows likely with rising tide of support including from biotech Read More »
There’s some recent stem cell good news out there including new papers and biotech developments. The stem cell and regenerative medicine field is really diverse and runs the gamut from really worrying stuff to very exciting, legit developments. In this post, I’m going to focus on the encouraging recent developments. What do I see as
Stem cell good news on biotechs & cool new organoid paper Read More »
I can see many reasons to be jolly on the regenerative medicine front as we get deeper into the holiday season as there is quite a lot of stem cell good news even if there is also some not so good news. In today’s post the focus is on the good news of late. Semma
Stem cell good news for the holidays: biotechs, FDA, organoids Read More »
Is there a proliferating stem cell fake news problem in the biotech world? More broadly, the SEC is cracking down on the mess that is fake biotech news, but what about fake news on stem cell biotechs more specifically? Already in the past year I’ve seen examples of possible stem cell fake news. Hyped press releases (PR)
Stem cell fake news driving biotech investors or vice versa…or what? Read More »
I’m putting together a list of stem cell and regenerative medicine biotech companies for a blog post, including both public and private. I’ve got a good list already, but want it to be fairly comprehensive. I’m also curious what readers think are the most promising ones and why. So weigh in with comments please or
What is your favorite stem cell/regen med biotech & why? Read More »
When potentially game changing new technologies are reported such as NgAgo gene editing, both scientists and the public get excited, but especially if such new reports stem from a single paper it is wise to take a cautious approach for a while. The key question is whether the new findings will turn out to be
Nature Biotechnology looking at NgAgo paper amidst reproducibility concerns Read More »
Stem cell studies continue to make big news with a mixed bag of trends including for stem cell biotech, and some good stem cell news and others not so much. Mesoblast ($MESO) had its stock suspended for quite so time recently in anticipation of a big announcement. When that news came today it was discouraging in
Stem cell biotech bites: Mesoblast, BioTime, MS, FDA Warning, & More Read More »
A sad, but not surprising day for the stem cell field as the biotech StemCells, Inc. announced that it is winding down its operations after terminating its spinal cord injury trial called the Pathway Study. The data generated so far did not justify continuing the trial. StemCells, Inc. (stock symbol STEM) has struggled financially for
End of line for StemCells Inc., pioneering & controversial stem cell biotech Read More »