The power and promise of artificial intelligence comes in a Pandora’s box full of novel and multi-dimensional enterprise risks—legal, regulatory, financial, operational, ethical and reputational—that […]
In the latest episode of the podcast Dominic Tyer speaks with Pierre Bourdage, who’s global head of biopharmaceuticals at Sandoz about the big issues in […]
Janssen’s Saskia De Haes, VP EMEA Regulatory Affairs, looks at how the pandemic response has shaped tomorrow’s regulatory landscape. In my 26 years of industry […]
I would like to recommend this piece at Stat about the details of the Biogen aducanumab approval. It’s behind the paywall, but it’s a deeply […]
It should be obvious, given previous posts here, that I think that the FDA approval of Biogen’s aducanumab for Alzheimer’s was a mistake. It is […]
As the world knows, the FDA approved Biogen’s anti-amyloid antibody today, surely the first marketed drug whose Phase III trial was stopped for futility. I […]
There’s a big FDA decision coming up in the next few days: whether or not to approve the Biogen antibody for Alzheimer’s (aducanumab). I’ve had […]
The announcement by the Biden administration about waiving IP rights to the coronavirus vaccines obviously calls for some comment. Keep in mind that I have […]
When it comes to developing cutting-edge innovations, Astellas aims to be at the forefront. The pharma organisation prides itself on having an open, collaborative, “science […]
Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability […]
I’ve been meaning to write about what has to be called a regulatory mystery. Eli Lilly obtained an Emergency Use Authorization for its monoclonal antibody […]
Longtime readers (and longtime drug industry folks!) may remember the Makena story from 2011. That is a progesterone ester drug that has been given to […]
That title is the only way that I can describe the events of the last few days. Like so many other things this year, what […]
I’ve been emphasizing for some time that our efforts to find and deploy a coronavirus vaccine have to be as transparent as possible to increase […]
I suppose that I’m going to have to say something about yesterday’s convalescent plasma announcement. First, the medical aspects: in my view, for what that’s […]
For some years now, Biomarin has been working on a gene therapy for hemophilia A. That’s the form of the disease caused by a deficiency […]
Copyright © 2024 | WordPress Theme by MH Themes
