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U.S. regulators said warnings about the risk of sudden hearing loss linked to popular drugs for impotence, including Viagra, Cialis and Levitra, would be added to the drugs' labels.
There was a time within the past couple of years that it seemed you couldn't open a major newspaper or watch a TV news program without seeing a story about the bird flu and Tamiflu--the antiviral medicine from Roche and Gilead Sciences. GILD invented the drug and later sold rights to Roche which pays GILD a royalty on sales.
For quite some time now analysts and investors have been speculating that big pharma would go on a biotech buying binge. So, will the announcement by Biogen Idec late Friday that it's putting itself on the market be the spark that ignites an M & A explosion in the sector? Perhaps.
Melanoma -- a type of skin cancer -- is the most common form of cancer. It can spread very quickly and the prognosis often is not good. The American Cancer Society estimates that nearly 60,000 new cases of melanoma will be diagnosed this year and more than 8,000 patients will die. You can find out more about it on the ACS's website.
This morning, the world's second biggest drug company, GlaxoSmithKline, announced that Andrew Witty will replace JP Garnier as CEO at the end of next May. It's been known for a while that Garnier would be retiring next year, and the question was who would be tapped to succeed him.
GlaxoSmithKline has picked Andrew Witty, currently president of its European pharmaceuticals business, to succeed Chief Executive Jean-Pierre Garnier from May 2008, it said on Monday.
BioCryst Pharmaceuticals drew the short straw, er, needle. The biotech company says a majority of patients in a mid-stage clinical trial of its experimental seasonal and pandemic flu antiviral Peramivir got the drug using too short of an injection needle.
So, I thought I'd be spending today monitoring the webcast of the FDA Advisory Committees that are meeting to decide whether doctors should use less of the anemia drugs from Amgen and Johnson & Johnson to treat kidney dialysis patients.
We've known that Merck has been testing its cervical cancer vaccine Gardasil on young men (16-23 years old). The company says major data on those clinical trials are expected next year and could help Merck win FDA approval of the shots for males as well as females. The first-of-its-kind product has already sparked a sociopolitical controversy with its recommended use for young women. Imagine the brouhaha if or when Merck starts selling it for young men.
A sex study published in the New England Journal of Medicine Thursday showed that people in their 70’s and 80’s are more sexually active than previously thought. More than a quarter of seniors up to age 85 reported having sex in the previous year. What's the trade?
BioMedTracker, which monitors drug development for investors, ran some numbers for me. As of August 13th, how does the number of FDA-approved drugs and "approvable" drugs compare to the same period a year ago? According to the company, drug approvals are down 16% and approvable letters are up 55%. An approvable letter is what the FDA issues when it believes it might someday okay a drug, but only if a company provides additional -- often publicly unspecified -- data. So, for investors, "approvable" is a euphemism for delay.
Yep, you probably could have called this one, but researchers have done an analysis of Dr. Steven Nissen's controversial meta-analysis that started the Avandia safety scare. Their findings are published in the Annals of Internal Medicine and touted and brought to my attention in an email from a GlaxoSmithKline PR person. A meta-analysis is what one of our contacts called "a mish-mash" of a bunch of clinical trials.
I have a clarification to make regarding my previous blog entry about the Chinese Hamster problem facing GlaxoSmithKline and Pozen. Thanks to blog-reader Brian Orelli with www.babybiotechs.com who caught the error and pointed it out in an email: "Chinese Hamster Ovary (CHO) cells are grown in tissue culture and the mega dose of the drug was given to the CHO cells growing in media in a tissue culture dish/flask in an incubator...
So, I just got off the Pozen conference call about the Trexima delay (by the way, it won't be called Trexima if/when it comes to market, as the FDA is asking Glaxo for a name change. The agency sometimes does this if, for example, it believes the name looks or sounds too much like an existing drug and could confuse pharmacists.)
U.S. regulators have delayed approval of an experimental two-in-one migraine drug from GlaxoSmithKline and Pozen yet again, sending Pozen stock down 45 percent on Thursday.
This morning we learned that the FDA has issued another "approvable" letter to Pozen and GlaxoSmithKline for their migraine drug Trexima over safety concerns. POZN shares are down big. The company has scheduled a conference call for 11 a.m. ET. This is the third regulatory stumbling block for this drug and puts it on a timeline now where it could end up competing...
As several of the major pharmaceutical companies struggle through a period of a relative dearth of big, new products, the job casualties and the share buybacks are piling up this earnings season. Today, Sanofi-Aventis is joining the group. The French drugmaker announced it will buy back more than $4 billion of its stock and get rid of even more sales reps.
So, GlaxoSmithKline escapes Gaithersburg with a 20-3 vote that Avandia may increase the risk of heaving a heart attack, but a 22-1 vote that the diabetes drug should stay on the market. And maybe, or maybe not, with a so-called "Black Box" warning. That'll be up to the FDA.
An independent advisory panel told the U.S. Food and Drug Administration that GlaxoSmithKline's widely used diabetes pill Avandia increased heart risk but the drug should remain on the market.
It is standing room only here at the advisory panel meeting on GlaxoSmithKline's Avandia. I count about 300 people in the main ballroom and about 50 more watching on closed circuit in an overflow breakout room. The place is crawling with PR people, especially from Glaxo which like most drug companies at the center of a storm like this one has set up a war room here.