Weekly Reads: Prasad Successor, Sammy Hagar Stem Cells, More on OSK Trial, Finnish Speaker Needed
Vinay Prasad is set to leave his role as head of the FDA's Center for Biologics Evaluation and Research (CBER within two weeks, prompting speculation about the agency’s future direction. A new flexible oversight framework for rare‑disease gene and cell therapies is being discussed, promising faster approvals but also heightened safety risks. Meanwhile, rock star Sammy Hagar touts biannual perinatal stem‑cell IVs, and researchers eye David Sinclair’s OSK anti‑aging trial alongside a $42 million ARPA‑H grant for osteoarthritis regeneration.
Weekly Reads: Federal Stem Cell Charges Disappear, SCBEM Ethics, Diet & MYCN Cancer, How to Make a Nose
The article examines the abrupt dismissal of former South Carolina lawmaker Stephen Goldfinch’s federal stem‑cell charge, underscoring the uneven enforcement of unapproved cellular therapies. It contrasts this with a pending federal indictment targeting peptide manufacturers, especially BPC‑157, highlighting regulatory blind...
Landmark Federal Indictment for Pop Peptides Alleged ‘Scheme’ Even as RFK Jr. May Soon Un-Ban Some
A federal grand jury indicted Dr. Justin Watkins, owner of Utah's TruHealth Clinic, for relabeling Chinese‑manufactured peptides and selling them to more than 200 patients without disclosing the source or FDA status. The indictment alleges that the clinic repackaged the...
Weekly Reads: 1st FDA-Approved CIRM Supported Therapy, Asymmetric Histone Inheritance, Stem Cell Retraction
The FDA has granted approval to KRESLADI, a gene‑editing therapy from Rocket Pharmaceuticals that treats severe leukocyte adhesion deficiency‑I (LAD‑I) in children without a matching bone‑marrow donor. This marks the first FDA‑approved product directly funded by California’s Institute for Regenerative...
Weekly Reads: Gattaca Stack, Animal Sacks, Custom iPS Cells, ImmunityBio FDA Warning, Mouse Cloning Limit
Weekly reads highlight several frontier biotech developments. The Gattaca Stack, a new database, tracks firms working on embryo models and artificial‑womb technologies. R3 Bio’s stem‑cell “organ sacks” aim to replace animal testing and could evolve into human organ bags, while...
FDA Investigating: US Patient Dies After Use of Placental Extract Laennec, Russian Med Student Also Died
The U.S. Food and Drug Administration has opened an investigation after a patient died following self‑injection of Laennec, an allogeneic placental extract imported from Japan. A similar fatality occurred in Russia involving health influencer Anna Kolyada, whose companion fell seriously...
Weekly Reads: Support Brain Tumor Work, Prasad Is Out (Again), Genetic Conditions, Texas AG, Immunotherapy Paper, SCBEM
The newsletter urges donations to support a lab studying lethal childhood glioma, noting NIH grant success rates of only 4‑5%. It reports FDA biologics chief Vinay Prasad’s second departure, a rare leadership turnover that could affect approval stability. Additional highlights...
Early Encouraging UC Davis Trial Data on Cell Therapy for Spina Bifida
A first‑in‑human phase 1 trial at UC Davis evaluated placental mesenchymal stem cells delivered intra‑uterinely to fetuses with myelomeningocele. Six pregnancies treated between June 2021 and December 2022 resulted in intact repair sites, no cerebrospinal fluid leaks, infections, or tumor formation, and MRI scans...
$24M Verdict Against Seattle Stem Cell Center Clinic in Man’s Death
Seattle Stem Cell Center was ordered to pay $24 million after a jury found the clinic liable for the 2019 death of Michael Trujillo, who suffered catastrophic bleeding following an undocumented epidural injection while on blood‑thinning medication. Evidence showed the procedure...
Weekly Reads: Longevity Hype Vs. Cool Research, Losing Your Y, FDA Maelstrom
This week’s coverage juxtaposes longevity hype with emerging science, highlighting David Sinclair’s bold claim that aging could be reversed within 10‑20 years, a new Nature paper confirming adult hippocampal neurogenesis, and research showing men lose the Y chromosome as they...
From Skin Biopsy to iPS Cell Proposals: Emails Involving George Church’s Personal Genome Project and Jeffrey Epstein
Recent court‑released Epstein files contain emails that link Harvard professor George Church’s Personal Genome Project to Jeffrey Epstein. The correspondence documents a skin‑biopsy taken from Epstein, proposals to generate induced pluripotent stem (iPS) cells, and even CRISPR editing ideas, with...
FDA OKs Risky, Pioneering OSK Rejuvenation Trial with Sinclair’s ER-100
The U.S. Food and Drug Administration has cleared an investigational new drug application for Life Biosciences' ER‑100, a viral gene‑therapy that delivers inducible Oct‑4, Sox‑2 and Klf‑4 (OSK) to the eye. The first‑in‑human trial will enroll a small cohort of...
Wyoming Stem Cell Bill Is Latest Risky, Anti-FDA State Legislation
Wyoming Senate introduced the Stem Cell Freedom Act, allowing clinical use of autologous mesenchymal stromal cells without FDA approval. The legislation shields physicians from disciplinary action if they recommend such therapies, provided they meet state‑defined standards. Critics argue the bill...
Weekly Reads: Human SCBEM Framework, Reporter Self-Injects Peptides, ASD, NAMs
A new two‑tier framework for human stem‑cell‑based embryo models (SCBEM) proposes a developmental ceiling of 56 days, sparking debate over its impact on clinical applications. The blog also highlights ethical concerns after a reporter injected wellness peptides on record, questioning...
In Support of the Roman Reed Spinal Cord Injury Research Act
The California legislature is poised to pass the Roman Reed Spinal Cord Injury Research Act, allocating $1 million annually for up to five years to revive the previously successful Roman’s Law. The original program funded $12.4 million in state grants, leveraged $82.4 million...