CNBC's Meg Tirrell reports the Drug Enforcement Administration is changing the rules around pain drugs like Vicodin. The drugs will be deemed "schedule 2 substances," versus the less restrictive "schedule 3."» Read More
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.
If you haven't been to the world's biggest drug company's homepage recently you might want to check it out. It used to be very corporate and stodgy. But earlier this month, the website got a facelift.
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.
U.S. health officials have determined that a schizophrenia drug developed by Wyeth and two other drugmakers is not approvable, the companies said Friday, dealing Wyeth a second setback in less than a month to an important product.
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.
Johnson & Johnson, the pharmaceutical giant which uses a Red Cross as its trademark, filed a lawsuit Wednesday against the American Red Cross, demanding that the charity halt the use of the red cross symbol on products it sells to the public.
Cardinal Health on Thursday said its quarterly net profit rose, led by strong demand for medical pumps and other devices in its Clinical Technologies and Services business.
Barr Pharmaceuticals said Wednesday quarterly earnings fell sharply, hurt by costs tied to an acquisition, but its operating profit beat Wall Street estimates as generic drug sales soared
A rebound in the financial sector and positive earnings surprises triggered gains for some of the most actively traded stocks on Tuesday.
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.
Corporate news and analyst upgrades were some of the catalysts behind the most actively traded stocks on Monday.
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...
Pharmaceutical company Novo Nordisk, the world's largest producer of insulin, said Friday that second-quarter net profit more than doubled and raised its guidance for the full year. Its shares rose more than 4%.
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.