Extracellular vesicles are generating excitement as tools for regenerative medicine and drug delivery — but no EV-based therapeutic has received market approval anywhere in the world. In a new Perspective article, we argue the barriers are not solely technical. They are also regulatory.

A genome-edited pig kidney I was pleased to be invited to reflect on the future of xenotransplantation and human genome editing recently in an interview on ABC’s The World with Beverley O’Connor. The interview was broadcast following news of the unfortunate passing of Richard “Rick” Slayman — the first human to have received a genome-edited […]

Last week, the biotech firm eGenesis supplied a donor kidney sourced from a genome-edited pig to a surgical team at Massachusetts General Hospital (MGH) in the US. The donated kidney was transplanted into a patient with end-stage renal disease whose existing kidney transplant (‘allotransplanted’ from a human) was wearing out. The FDA had granted an […]

Fidge v Pfizer is notable for making several provisional holdings. Among those was Rofe J’s holding that it is not a ‘necessary incident of medical practice’ for doctors to challenge government decisions based on alleged breaches of legislation, even when done in a purported attempt to protect patients’ health.

On BioEdge, Dr Patrick Foong and I quickly run through the bioethical perturbations that have come with the relatively rapid approval of Casgevy, the first-ever approved genome-editing therapy that utilises CRISPR/Cas 9. In some ways, it could be said that Casgevy is the first-ever approved genome therapy ‘full-stop’, because other categories of gene therapy have […]

Exa-cel and the FDA review Just last week, on 31 October, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee met to discuss Vertex Pharma’s Biologics License Application for Exagamglogene autotemcel (or exa-cel, and formerly known as CTX-001) — a cell-based gene therapy designed to treat sickle-cell diseases. I have written about exa-cel many times […]

Recently, a new Bill to allow mitochondrial donation was tabled in the federal Parliament. Will it achieve all that it promises?

The Vaporfly study and the four per cent claim In November 2017, Wouter Hoogkamer and colleagues published the study that underlies Nike’s claim that its new shoe — the Zoom Vaporfly 4% (VF4%) — improves one’s running by around 4%. Hoogkamer, a research associate at the University of Colorado, published the study in the journal […]

Measuring emotion at the Burghölzli In July, 1907, the Swiss psychiatrist Carl Gustav Jung and American neurologist Frederick Peterson published the results of their investigations into the galvanometer and the pneumograph in BRAIN, the journal of neurology. The pair had subjected various people to these instruments—people they had identified as “normal” and “insane”—in an attempt […]

This paper was presented at a conference held on 20–21 February 2012 at The University of Sydney. More details about the event are below.