The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past […]
3rd Invitrx warning highlights FDA oversight weakness Read More »
I started The Screamers a few years back as a biomedical science hype award. It’s kind of in the spirit of an Ig Noble Prize in the sense of an alternative “award”, but in this case for hype. In 2020, sadly the FDA Commissioner at the time Stephen Hahn won The Screamers award for a
2022 The Screamers Science Hype Award goes to The BBC Read More »
It’s that time of year again when I grade my previous year’s predictions for the stem cell & regenerative medicine space. Overall, I did better than a typical year. I give the 2022 predictions an A- overall. This exercise can be kind of fun but also humbling. For example, I tend to be too optimistic
Grading my 2022 regenerative medicine predictions Read More »
Patients regularly reach out and ask me about something called HSCT. “What is HSCT?” and is it proven as a therapy? Often the patients asking about this have multiple sclerosis (MS) or some other autoimmune disease. I’m not a physician so I can’t give medical advice, but as a stem cell biologist here at UC
What is HSCT & its possible roles in MS treatment? Read More »
Firms that are active in the biologics space face many possible challenges but the possibility of getting an FDA warning letter is one of the most intense. The goal of today’s post is to explain what an FDA warning letter is all about. This analysis includes what such a letter means and what steps come
What is an FDA warning letter & how should firms respond Read More »
There was a time when The Niche was just about the only stem cell blog or even stem cell-dedicated website more generally across the globe. I realized early on that I needed to reach people who don’t speak English or for whom English is not their first language. This goal was crucial for effective educational
The Niche foreign language outreach program: 2.5 million reads Read More »
Many firms that generally fall into the category of unproven stem cell or cell therapy clinics have a way of reinventing themselves and I’ve seen this with one formerly named the Lung Institute that is now called Centers for Respiratory Health. First the Lung Institute became the Lung Health Institute. Now that firm has become
Centers for Respiratory Health is new incarnation of clinic Lung Health Institute Read More »
It’s very challenging to be an academic scientist even under normal circumstances so when a government starts going after researchers for things like supposed irregularities in funding disclosures, it can cause serious problems if not carefully overseen. We’ll start this week’s recommended reads with the feds monitoring such disclosures and even making referrals to the
Weekly reads: Yale scientist suspended, WA AG sues clinic, new pubs Read More »
The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical
FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance Read More »
What if some legit place like The Mayo Clinic charged people just for the opportunity to talk to a doctor about possibly enrolling in a clinical trial? Imagine this kind of conversation. “Hey, Doc, I have this medical problem and heard you have a relevant clinical trial. Tell me about it.” Then the doctor fills
Mayo Clinic charges patients just to talk about clinical trials? Read More »