To put it mildly, regulators at the FDA have a few problems with Minerva’s $NERV failed schizophrenia drug roluperidone.

The biotech spelled it out in a statement Tuesday morning, noting that in their Type C meeting the agency noted:

— The Phase IIb did not use the commercial formulation of the drug.

— The trial was conducted completely outside the US.

— The Phase III failed — at both doses — and “does not appear to be capable of supporting substantial evidence of effectiveness.”

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

SUBSCRIBE SIGN IN

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

SUBSCRIBE SIGN IN

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

SUBSCRIBE SIGN IN

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

SUBSCRIBE SIGN IN