The FDA panel did not officially vote on an approval of the drug, but 15 out of 17 members were of the opinion that the lack of statistical significance in BioMarin's late-stage study weakened the findings from two earlier studies. The FDA will decide on the approval of the drug by Dec. 27, after considering the panel's comments. "I don't think they will necessarily...» Read More
I have a confession to make. I try to be as transparent as possible, to share as much information as I can about how the sausage is made. To that end, on at least a few occasions I’ve mentioned on this blog and on CNBC, that I’ve been on 10 milligrams of Lipitor.
This morning the apparently Red Bull-fueled (or maybe he's a Starbucks triple-shot guy) biotech analyst at Deutsche Bank, Dr. Mark Schoenebaum, did a deep dive for clients in a presentation he called, "Getting ready for summer!"
To almost no one's surprise, for the first time in 41 years, the World Health Organization has declared a full-blown swine flu pandemic. But the declaration is tied more to the geographic spread of the virus than it is to its virulence.
Medtronic spokesman Steve Cragle sent CNBC this clarification to Mr. Hawkins' answer to Mike Huckman's question regarding the Senate investigation into a doctor who has done consulting work for MDT.
"It's a risky business." I don't think I'll ever forget when a Chief Financial Officer said that at an investor conference last year in lieu of reading the whole boring boilerplate "Safe Harbor Statement."
In less than two weeks, there've been four pretty significant events in biopharma. And, hopefully, after ADA things will begin to settle down a bit for the summer.
A year or so ago, when customers buttonholed the pharmacists at Almand’s Drug Store here the questions were invariably about dosing or side effects. These days, they are almost always about cost.
The cost of drugs was a hot topic at ASCO this year, especially with the release of the big test results combining two very expensive treatments for lung cancer. The study showed using Avastin from Roche and Genentech and a pill, Tarceva, from OSI Pharmaceuticals, Roche and Genentech slowed down progression of the disease by a little more than a month.
I'm happy to report that I'm scribbling out this blog from the air-conditioned comfort of the convention center in Orlando. It's the first time in my six or seven years of covering ASCO that the organization has let CNBC broadcast live from inside. And, guess what? No one seems freaked out about it.
How will male General Motors retirees get their motor runnin'? Do they start paying for their impotence drugs out of their own pocket? Because apparently, under the new deal the company won't pick up the tab anymore.
Consumers may be saving more and spending less, but big pharma is on a shopping spree. And I'm not talking about the really big deals including Roche buying Genentech, Pfizer buying Wyeth and Merck buying Schering-Plough. I'm talking about the two deals that have been done in less than a week between major drug companies and baby biotechs specializing in oncology.
I'm juggling the Amylin Pharmaceuticals proxy fight, then ASCO (American Society of Clinical Oncology), then the Biogen Idec shareholder meeting and then the ADA (American Diabetes Association) meeting all within a week-and-a-half.
This fall ABC is launching a new show with Courtney Cox called "Cougar Town." Courtney was one of my favorite "Friends" stars and cougars are certainly a hot cultural phenomenon. Could cougars be five minutes ago by the time the show premieres? Perhaps. But maybe ABC has a hit on its hands. New TV shows are always a roll of the dice. And so is Johnson & Johnson's journey into "Cougar Town."
It's going to be a crazy busy, stressful couple of weeks. A shareholder meeting, a medical meeting, then another shareholder meeting and finally another medical meeting.
I didn’t inhale. It’s the truth. I swear. I have never ever taken a toke on a joint or even a cigarette. Growing up, my parents were both smokers and I think I developed such a distaste for the constant cloud that it just never held any appeal for me.
Cracking down on medical industry payments to doctors, the Vermont legislature has passed a law requiring drug and device makers to publicly disclose all money given to physicians and other health care providers, naming names and listing dollar amounts, the New York Times reports.
Medtronic may have set a record. The world's biggest medical device maker put out six press releases this morning.
Pfizer Chairman and CEO Jeff Kindler last year repeatedly said big deals in big pharma don't work. But, he added, he'd never say never. And sure enough, this year Kindler's buying Wyeth.
This takes the prize for the most dangerously optimistic acronym for a clinical trial. But MADIT (pronounced "made it") made it. Some folks with a lot of chutzpah at Guidant, now owned by Boston Scientific, apparently came up with the name for their big studies on implantable cardio defibrillators.
Over the past few months I've blogged a couple of times about the public service announcement Pfizer produced in the UK to discourage guys from buying and taking counterfeit Viagra.