Cigna Corp. rose $2.18 or 2.6 percent, to $86.50. Humana Inc. rose $2.09 or 2.1 percent, to $104.00. UnitedHealth Group rose$. 75 or 1.0 percent, to $73.50.» Read More
Usually when a company announces cost cuts that will help improve cash flow and buoy profits, investors cheer and buy the stock. After the bell yesterday, Amgen revealed it's going to get rid of as many as 2,600 employees, cut its capital expenditures this year and next by nearly $2 billion and close or downsize plants. The measures are being taken to help absorb the blow from plummeting sales of Amgen's anemia drug, Aranesp, which is facing intense safety and reimbursement issues. This morning the stock is trading at a new multi-year low.
Shares of Amylin Pharmaceuticals and Alkermes are rallying today after FBR Biotech Analyst, Jim Reddoch, put out a research note saying the once-a-week diabetes drug they're working on could be a $3 billion-a-year seller. AMLN shares have been on a tear in recent months, rising from about $37 in March to nearly $50 today. That's on investor anticipation of robust test results and continued speculation that AMLN could get taken out.
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.
For the second time in two weeks, an op-ed item appears in The Wall Street Journal today calling out the FDA for its record on timely approval of cancer drugs.
Bryan Gaffin, VP, Group Creative Director at G2 Direct & Digital writes to say that his division and not G2 Branding & Design is responsible for the new Pfizer website. They're part of the same company, WPP Group, but separate divisions. Credit where credit is due.
After falling to a new low on Friday, Bernstein Biotech Analyst, Geoffrey Porges, is upgrading shares of AMGN from Market Perform to Outperform. Investors are bidding up the beaten down stock in midday trading. Bernstein makes a market in the stock.
The Los Angeles Times reports in a front-page article that Amgen may announce layoffs soon. The report attributes the information that the company may get rid of 15% of its employees within the next several weeks to "three people familiar with the matter".
Late Thursday, ImClone Systems announced it has finally hired a permanent CEO. It'd been without one for about two years. The biotech company which makes the cancer drug Erbitux and became reluctantly famous in the Martha Stewart stock-trading case tapped a guy named John Johnson for the role.
Johnson & Johnson, the drug/medical device/consumer health products company reeling from a plunge in sales of its anemia drug, Procrit, and its drug-coated stent, Cypher, is going to court. Not to defend a lucrative pharmaceutical patent, but to get The Red Cross to stop using its red cross logo on certain marketed products like humidifiers and grooming tools.
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.
In very early trading MRK shares are rallying this morning on the wings of an upgrade at Cowen & Co. by analyst Steve Scala from Neutral to Outperform. He's been at a Neutral since a year and one month ago when the stock was sitting in the 30s. Today it's in the low 50s.
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.)
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.
A hospital in Pittsburgh is banning Crocs, the comfy rubbery shoes with holes in them. Hospital officials call them a hazard, fearing a nurse might drop a syringe on his or her foot and, bingo! One nurse tells the AP that's a croc. "I mean, I can get a needle stuck in my arm or my leg."
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.
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.
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.