*AstraZeneca, Pfizer, UK charity link in multi-drug trial. Instead of testing one drug at a time, a novel lung cancer study announced on Thursday will allow British researchers to test up to 14 drugs from AstraZeneca and Pfizer at the same time within one trial.» Read More
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.
Bertha Coombs sat down with two key players in the healthcare reform debate, one in the private sector, the other in the public sector.
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.
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?
With little or no fanfare Pfizer launched a new ad campaign for its erectile dysfunction drug Viagra on NBC Nightly News last night. Pfizer has gotten into a bit of trouble before for its relatively racy Viagra spots like the "Horny Devil" campaign featuring the guy with two horns growing out of his head. This time it's got a bunch of 40-something guys sitting around a dusty barn singing "Viva Viagra" to the tune of Elvis' "Viva Las Vegas".
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.
Pfizer Chairman and CEO Jeff Kindler had some explaining to do on the company's earnings conference call this afternoon. He started by telling analysts, investors and reporters who were listening in (everyone's in a listen-only mode, only the analysts are allowed to ask questions), "Let me be direct. It was a tough quarter."
Yesterday, I blogged that you should watch the Lipitor number in Pfizer's earnings report today. Well, the world's biggest drug company, is having major problems with the world's biggest-selling drug. Lipitor sales fell a surprising 25% in the U.S. and 13% worldwide in the second quarter. And the company says for the full year revenue from the cholesterol fighter could be down as much as 5%.
The headline might say, "Johnson & Johnson Beats the Street," but investors are looking behind it and that's what is pushing this Dow component down this morning. For example, JNJ says its topline growth would have been just 3.6% instead of 13% if it had not bought Pfizer's consumer health care business last year for $16.6 billion. JNJ is kind of a three-pronged hybrid: pharma, medical devices and consumer healthcare.
These days, it's not uncommon to see campaigns calling for the withdrawal of a drug from the market because of safety concerns. That's why this campaign urging the approval of a drug is extraordinary. Proponents of Dendreon's Provenge took out this no-frills, half-page ad in the opinion section of Sunday's edition of "The Washington Post".
A couple of months ago I took ImClone to task here for putting a Hollywood studio executive on its Board of Directors. The post caused me to be frozen out of communication with the company--calls were not returned, emails did not get a reply. We've since mended fences and it looks like IMCL may have gotten a message. Here's part of its press release issued late yesterday announcing that Dr. Thomas Deuel is coming onto the Board.
While I'm sitting in a plane on the tarmac at Newark Liberty Airport for going on four hours now I write about the latest twist and turn in the Dendreon saga. Late Tuesday, in an SEC filing, the company disclosed that it got a letter dated July 9th informing Dendreon that the agency has launched an informal inquiry "related to the Company’s clinical trials for Provenge .
In the "Sunday Styles" section of "The New York Times" the paper runs a very prestigious weekly feature known as "Vows". It's a relatively long write-up of someone's wedding and accompanied by pictures from the event. Yesterday, the Times highlighted the ceremony of Andrew Solomon and John Habich (for at least a few years now, The Times has included same-sex partnerships in its "Weddings/Celebrations").
Below the fold on today's front page of the "The Washington Post" is an article headlined, "FDA Delay in Cancer Therapy is Attacked". It begins with an anecdote that I had reported a month ago during our live coverage from ASCO--that the outspoken critics of Dendreon's Provenge had hired private security to protect them during the cancer conference because they'd allegedly received threats from Provenge proponents. Most of the article covers familiar ground...
The 4th of July arrived a day early for investors in Dendreon. The stock is up, yet again, on heavy volume this morning after I reported on a new review published in the journal of the American Association of Cancer Research about therapeutic cancer vaccines (see video below). Dendreon's Provenge is a therapeutic vaccine. That means it's given after you get the disease to try to power your own immune system to combat it. It shouldn't be confused with traditional preventive vaccines which are given to hopefully keep you from coming down with something.
Jonathan Gruber, a professor of economics at the Massachusetts Institute of Technology, told CNBC’s “Morning Call” that he believes the Bay State’s new universal health plan mandate can succeed on the national level.
The battle between two drug giants over the cervical cancer vaccine market is heating up. A study being published in the British medical journal, "The Lancet," says GlaxoSmithKline's shot called "Cervarix" may be different from Merck's Gardasil.
Shares of the wildly popular and volatile Dendreon were treading water on unremarkable, relatively low volume for most of the day today. Then, all of a sudden, around 2:30 there was a big spike in the stock and volume surged. With less than 15 minutes left until the closing bell more than 11 million shares have been traded. The daily average recently is nearly 24 million. The shares are up more than 10%. There's still a large, but smaller (month over month) short interest in the stock.
The huge auditorium at the McCormick Place Convention Center was packed to the rafters. It was standing room only in the 45-hundred seat theater, although the fire department wouldn't let people stand. The doctors, scientists, and educators at the American Diabetes Association's Annual Meeting came to see the rock stars of their world--Dr. Steven Nissen who wrote the controversial New England Journal of Medicine report questioning the safety of GlaxoSmithKline's Avandia and Dr. Phillip Home who wrote--also in NEJM--the subsequent interim analysis of a GSK-sponsored study that, so far, supports Avandia's safety.