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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.
As a big FDA Advisory Committee meeting is taking place here in Gaithersburg, Maryland on the safety of GlaxoSmithKline's Avandia, the head of the agency has been named in a separate lawsuit. A non-profit group calling itself "CareToLive" is suing FDA Commissioner Dr. Andrew von Eschenbach over the recent delay in the potential approval of Dendreon's Provenge.
M&A news and stock buybacks were some of the catalysts behind the most actively traded stocks on Friday.
GlaxoSmithKline took a further step to boost its new drug pipeline on Friday by clinching a drug development deal potentially worth more than $1.5 billion with U.S. biotech firm Targacept.
AstraZeneca plans to axe around 7,600 jobs as part of an expanded cost-cutting drive, it said on Thursday as it nudged up its 2007 earnings outlook.
I think I just killed a tree. This morning I printed out the GlaxoSmithKline and FDA documents that were posted on the agency's Web site ahead of the advisory committee meeting on Avandia safety next Monday. About 700 pages! Nearly as many pages as the new "Harry Potter" book, but not nearly as entertaining.
A new study of health insurance records of more than 400,000 U.S. diabetics found no higher risk of heart attacks with GlaxoSmithKline Plc's pill Avandia when compared with other oral diabetes drugs, the drugmaker said in documents made public Thursday.
Stocks closed higher as better-than-expected earnings offset credit worries. "We do see volatility pick up in earnings season, but other reasons are the subprime concerns, the housing market concerns, as well as the corporate debt concerns," said Sean Clark of Clark Capital Management.
Quarterly earnings reports and new drug trial data were some of the catalysts behind the most actively traded stocks on Wednesday.