The FDA Should Provisionally Approve Vascepa
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) rocked the biotech industry last week by voting 9 to 2 against approval of Amarin Pharmaceuticals Inc.’s fish-oil derived omega-3 supplement Vascepa in the supplemental indication of mixed dyslipidemia. The drug…
A $100B Market Cap: Now That’s a Big Deal for Biotech
Remember the heady days about eight years ago when Amgen Inc. and Genentech Inc., prior to its acquisition by Basel, Switzerland-based Roche AG, both vied for top spot in terms of market capitalization? At that time, both companies briefly commanded…
Bug Juice: Antibiotics’ Slow Drip Turns to Flow
I’m terrified of hospitals. Not so many years ago, this would have been an absurd remark. With doctors and high-tech medical care all around, a hospital seemed like one of the safer places in the world to be. But then,…
It’s How You Look at the Vial
What’s in a biosimilar name? That depends on whether the vial is half empty or half full. Seeing it as half full, many generic makers focus on the similarities between a follow-on and its reference biologic. Because of those similarities,…
Spittin’ Image: Or, How I Am Probably Going to Die
“Once you obtain your genetic information, the knowledge is irrevocable,” warn the service terms at saliva-testing firm 23andMe.com. The news wasn’t so bad, except for Alzheimer’s. Also, I’m sort of related to Stephen Colbert. Of course, 23andMe, of Mountain View,…
Playing Truth and Consequences with NIH Grants
When it comes to the National Institutes of Health’s (NIH) funding for medical research, it’s not a matter of truth or consequences. It’s more like truth and unintended consequences. Cheered on by prominent researchers, the NIH has embarked on an…
Bubbleology and Biotech’s Bull Run
Our recent analysis of biotech’s second quarter performance showed, for public biotech companies at least, their bull run that began more than 18 months ago is showing no signs of slowing down. Since the beginning of 2012 the Nasdaq Biotechnology…
History, Mystery, Gastronomy in the Mix in BioWorld’s 7th Annual Biotech Summer Reading List
With the official start of summer just around the corner, BioWorld again polled industry execs and our own indefatigable staff to construct a diverse list of titles for your reading pleasure. Whether the summer solstice takes you to a deck…
Oh, Give it Iressa! Nope: ‘Bad Pharma’ Firms Need to Tell More
So urgently did I think I wanted to read Ben Goldacre’s Bad Pharma, that I ordered it from Amazon’s UK site last November, unwilling to wait for U.S. publication – which happened just as I reached the end, polishing off…
Patients Want More than Check-the-Box Experience
Patients getting their four minutes to say how an experimental drug changed their life or gave them hope have become a routine part of nearly every FDA advisory committee meeting – as routine as the call to order or the…
