Regulatory uncertainty threatens biotech innovation

Sun, 15 Feb 2026 22:32:00 -0500

Another post from the Clinical Trials Abundance blog, this time by Ruxandra Teslo, on how the recent refusal-to-file by the US FDA for Moderna’s new mRNA influenza vaccine increases regulatory uncertainty and threatens innovation across the entire biotechnology sector. The decision reportedly came after the country’s top vaccine regulator, Dr. Vinay Prasad, overruled career staff to quash Moderna’s application. This is just one more blow against mRNA vaccine technology to come from Health and Human services, the US federal health agency led by the world’s most prominent antivaxxer, Robert F. Kennedy Jr.

The case for sharing clinical trial data

Tue, 10 Feb 2026 19:39:00 -0500

Saloni Dattani of the excellent Works in Progress magazine (and formerly of Our World in Data) launched a new Substack today called The Clinical Trials Abundance blog. The first post is on the case for sharing clinical trial data. We have been gradually moving toward mandatory reporting of clinical trial results (though enforcement is another question), but sharing data would be one step further. Even though clinical trials rely on the trust (and often money) of the public, it can be very difficult to gain access to the raw results, even if journal article authors claim they are “available upon request”. A norm of clinical trial data sharing would not only increase the confidence in published results but also aid future drug development, reduce expensive redundancy, and improve meta-analyses (which are often forced to rely on heterogeneous summary measures).

Clinical Trials on Big Muddy

Regulatory uncertainty threatens biotech innovation

The case for sharing clinical trial data