Biosimilar regulation: 1984 v. 2014
It’s 1984. The year opens with the demise of Ma Bell, as the Bell System is broken into smaller, regional telephone companies. The idea is to end Ma’s nationwide monopoly, but the result is a handful of smaller monopolies since there…
Drug pricing: Are we paying for efficacy or innovation?
What if we paid professional athletes only when they won? What if spectators got their tickets refunded whenever the home team lost? That might make that $1,300 Super Bowl ticket a little easier to purchase. And, hey, perhaps that might…
Happy Holidays! BioWorld’s 7th Annual Biotech Gift Guide
Who needs Black Friday and Cyber Monday, anyway? True biotech aficionados know they can find the perfect gift for everyone on their holiday list in BioWorld’s 7th Annual Biotech Holiday Gift Guide. Shoppers, start your engines. Personal Health Last year,…
An Asia Strategy is Not Optional
“If you plan to be around five or 10 years from now, you have to have a Chinese strategy.” That poignant comment in a BioWorld Today article came from Joshua Boger in 2011. The founder and former CEO of Vertex…
Patient Experience Still Undervalued in Regulating Drugs
As I write this, I’m sitting in the University of British Columbia/Vancouver General Hospital (UBC/VGH) Eye Care Centre, where my husband, Chuck, is completing post-tests at the conclusion of a six-month study on prosopagnosia, otherwise known as face blindness. The…
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,…
