President Donald Trump is set to pick oncologist Stephen Hahn, currently chief medical executive at MD Anderson Cancer Center in Houston, as the next FDA commissioner, forgoing current leader Ned Sharpless.
This is according to The Wall Street Journal, citing sources “familiar with the matter.”
The sources told the WSJ the pick is expected to be confirmed next week, in time for the end of Sharpless’ acting tenure, which is up Nov. 1. The Senate would need to confirm a new commissioner.
Sharpless took over on a temporary basis after media and biopharma favorite Scott Gottlieb unexpectedly left in the spring, later to take on a series of healthcare company roles.
Sharpless, formerly director of the National Cancer Institute, is still seen as a front-runner, but Hahn, formerly chairman of radiation oncology at the University of Pennsylvania School of Medicine, has been edging into the race in recent weeks, according to reports.
The FDA has been undergoing something of a cultural shift in recent years, with a focus on speedy reviews but arguably at the expensive of a slower, more considered approach to drug approvals.
Some greenlights, such as for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) therapy three years ago, saw internal and external wrangling at the regulator about whether the bar was being lowered. There are also whispers as to how political the FDA’s rejection of Sarepta’s second attempted DMD approval was, and as a backlash to its first.
With Trump being elected in 2016 and his mandate of slashing regulation in general to cut costs and boost efficacy, concerns deepened that his pick(s) may lower that bar further.
A big test of this is on the horizon: namely, with Biogen’s once failed and canned Alzheimer’s disease drug aducanumab, now resurrected in time for Halloween and set to spook more than a few FDA insiders.
Biogen, working some data magic/dredging operation, found that their drug may actually work in some Alzheimer’s patients, though skepticism is sky-high from some analysts and bio-Twitterati (though investors, not so much).
Biogen had it said spoken with the FDA, which appeared happy for it to attempt to file the drug. Anything could happen: a refuse to file notice, a demand for another phase 3 trial, a hostile AdComm, even a flat-out no. Whatever the decision and path, this will be a litmus test for any commissioner as well as the FDA itself.
By Ben Adams
Source: Fierce Biotech
After more than two years of leading LEO Pharma through a major transformation and a change of capital structure in a volatile environment during the global pandemic, the Board of Directors of LEO Pharma and President and CEO Catherine Mazzacco have jointly agreed that she will resign from her current role and leave the company on November 30, 2021.
Lonza and Bioqube Ventures, a European venture capital firm with a dual investment model including venture creation, have partnered to develop and manufacture biologics and small molecules. This is a five-year services agreement in which Lonza will provide advice and services to Bioqube Ventures’ portfolio companies.
UCB has granted to Chiesi global exclusive rights to develop, manufacture and commercialize zampilimab, a monoclonal antibody targeting transglutaminase 2 (TG2), an enzyme associated in fibrotic diseases. UCB will receive upfront payment, future milestone payments and net sales royalties.