After speaking with the Genfit CEO, CNBC's Meg Tirrell discusses the company's future and the potential opportunity.» Read More
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.
French pharmaceuticals group Sanofi-Aventis said on Wednesday second-quarter adjusted net profit fell 6.3 percent, more than analysts had expected, as generic competition and a strong euro hit sales.
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.
Earnings reports and corporate announcements were some of the catalysts behind the most actively traded stocks on Tuesday.
A sell-off is the perfect time to find broken stocks, and Cramer has his eye on several that investors should know about.Investing can be confusing. Luckily, Cramer has mapped out some road rules for all you Home Gamers trying to navigate the jungle that is Wall Street. Think of it as "Mad Money 101" –- some fundamental advice to keep in mind as you play the market. Whether you're a first time investor or a seasoned financier, it's always good to remember the basics.
With stocks in rally mode, it's appropriate to drill down for answers as well as take a look at some key sectors.
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.
Earnings reports and corporate announcements were some of the catalysts behind the most actively traded stocks on Monday.
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.
Sepracor posted lower-than-expected results Friday and cut its 2007 outlook amid competition for its insomnia drug and reduced reimbursement for its asthma drug, sending its shares down 20 percent.
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.
Bristol-Myers Squibb Thursday said quarterly earnings rose 6 percent on resumed growth for its Plavix blood-clot preventer, and higher sales of newer drugs that offset waning demand for older products.
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.