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
Vinay Prasad has only less than two weeks left at the FDA atop CBER. I’ve been trying to imagine where CBER goes from here after he exits. It feels like FDA Commissioner Marty Makary and RFK Jr. will likely be the real leaders of CBER moving forward on key decisions. Under that pressure, will the
Over the years people have asked me why those selling unproven stem cells and more recently peptides haven’t faced more pushback. Cases do arise, but they often go nowhere. Civil cases like patient lawsuits against stem cell clinics are often settled. These are generally subject to confidentiality agreements. On the peptide front, we’ll have to
It’s been a whirlwind of news about pop peptides like BPC-157 and now one of the first indictments related to marketing of these unproven drugs at a clinic. While RFK Jr. may want to unleash previously banned peptides on the public, it hasn’t happened yet. Those still selling these unproven peptides anyway have had to