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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.
GlaxoSmithKline is rallying today after reporting that second quarter sales of its diabetes drug Avandia, fell 31% in the U.S. from the same time a year ago. And from the first quarter of this year to the second quarter, revenue in the U.S. from the blockbuster pill slid $120 million. So, why are investors buying the beaten-down stock?
GlaxoSmithKline more than doubled its share buyback programme to 12 billion pounds ($25billion) on Wednesday, boosting its shares even as sliding sales of diabetes drug Avandia held back second-quarter profit.
After a disappointing week for big pharma earnings, Merck and Schering-Plough start the second-half of the sector's reporting season with a bang. Both companies beat the Street on the top and bottom lines. Merck also raised its full-year earnings guidance to boot. And investors love it. Look at the huge move in the Dow component.
With a couple of exceptions the pharma earnings season has failed to impress Wall Street, so far. Take a look at the one week performance of the Amex Pharmaceutical Index versus the Dow. Next week there's no let-up. Right out of the gate on Monday morning Merck and Schering-Plough report.
GlaxoSmithKline said that its cervical cancer vaccine Cervarix received a positive opinion from the European Committee for Human Medicinal Products and will now be proposed for final approval by the European Commission.
Novartis cut its full-year results outlook as generic competition pressured sales of a key blood-pressure drug, and said U.S. regulators had delayed the approval process for an important cancer treatment.