If you take a statin to improve your lipid profile, someday could you undergo LDL gene editing instead? Might that day be sooner than we think? A new paper has generated great interest in this topic including in the media. LDL gene editing For example, we have: One-and-Done Heart Disease Prevention? Scientists Show It May […]
I’ve been following Altos Labs since its inception. The institution has intriguing, ambitious goals. For that reason, it’s been interesting that in terms of news on Altos, things have been relatively quiet for the last 4+ years. Some big changes have happened recently though. Altos Labs is high on talent, but nicely low-key on PR
Platelet-rich plasma or PRP is a regenerative product that has grown in popularity. The literature on clinical applications of PRP is all over the place. Whether it works or not for any particular application is unclear to me. Many orthopedists seem enthused about it. I haven’t seen any major adverse events linked to PRP. PRP
I’ve been thinking more about the interplay between patient voices and FDA oversight of emerging cell and gene therapies. How do we find integration and balance here? In line with this topic, the FDA’s Megha Kaushal, MD spoke last week in Boston at ASGCT 2026 on patient voices. Kaushal is the Acting Deputy Director, Office
FDA’s Megha Kaushal ASGCT talk: PFDD, patient voices, decision-making Read More »
Marty Makary is officially out at the FDA. From STAT: Makary departs FDA amid turmoil as Diamantas, agency’s top food official, steps in. But there’s more going on here in what looks like an agency leadership purge. This is so crazy that it’s hard to imagine a coherent path forward. Next level chaos: Marty Makary
I haven’t written that much about heritable human gene editing recently, but the topic and related technologies are still out there. We need to keep paying attention and having dialogue. For that reason it was great to watch a lively debate in this space between I. Glenn Cohen and Cathy Tie. Some of my more
Perspectives on Cathy Tie v. Glenn Cohen heritable human gene editing debate Read More »
Have we reached the reproductive frontier of lab-grown sperm? Producing oocytes in the lab has always been thought to be the initial focus in this arena. It was thought that figuring out the way to maked lab-grown sperm would take longer. Now a new report suggests both sperm and eggs can be made by in
I’ve been trying to dig out from all the stuff that piled up while I was working toward a big grant deadline last week, catch up on recent news and papers, and during this time I was excited to see the news about an approved gene therapy for a rare form of deafness. Let’s start
Yesterday was Vinay Prasad’s last day as the Director of CBER, the FDA’s biologics branch and as of today Katherine Szarama is Acting Director. Is there some significance to Szarama being acting director? It’s hard to say. Most signs seem to suggest someone else will become the permanent leader. Katherine Szarama background From Politico: “Szarama
Katherine Szarama, PhD, named Acting CBER Director: who’s next? Read More »
The last 3 weeks have been extremely busy with grant work, but one recent bit of news that caught my eye was UCB’s $1 billion+ acquisition of Neurona. Neurona has been on my radar screen for years. Neurona and stem cells for epilepsy Here’s the news: UCB pays $650M+ for Neurona, marking ‘strategic expansion’ into