LONDON— Pharma giant GSK said Thursday it is submitting its malaria vaccine for regulatory approval to the European Medicines Agency. In a statement on Thursday, GSK said its vaccine is aimed only for use against the malaria parasite most prevalent in Africa.» Read More
Call it a stellar, mythic merger. This morning Isis Pharmaceuticals (named after the goddess in Egyptian mythology) and Alnylam Pharmaceuticals (named after the center star in Orion's belt) announced they're forming a joint venture called Regulus Therapeutics, LLC (named after the brightest star in the constellation Leo). I'm sensing a theme here.
An update from the NewsMakers in Biotech conference in NYC on an item of intense interest. Amylin Pharmaceuticals just held a well-attended PowerPoint presentation followed by a very cramped breakout session. And pretty much the only thing investors and analysts wanted to talk about is Byetta LAR (long-acting release).
Blogging from the 14th NewsMakers in the Biotech Industry conference put on by BioCentury and Thomson Financial in Manhattan. It's a rare opportunity to spend a day getting possible story ideas and networking with sources.
The gloves are off. Overnight, Pfizer came out with a new study on the world's top-selling drug, Lipitor, for cholesterol. The company says if you switch from its drug to generic Zocor you've got a 30% greater chance of dying from a heart attack, stroke or some other "major cardiovascular" event.
I'll be out of the office for an extra-long holiday weekend, so I'm emptying out the blog inbox before I go. Nick Stavriotis sent an email to clarify his previous incomplete statement regarding the FDA's "overrule" of the Dendreon Provenge advisory committee recommendation: "...my words should have said 'refusal to follow an overwhelming...
We've known that Merck has been testing its cervical cancer vaccine Gardasil on young men (16-23 years old). The company says major data on those clinical trials are expected next year and could help Merck win FDA approval of the shots for males as well as females. The first-of-its-kind product has already sparked a sociopolitical controversy with its recommended use for young women. Imagine the brouhaha if or when Merck starts selling it for young men.
Shares of Neurochem today are trading at a new low after the Canadian biotech announced its developmental drug for Alzheimer's didn't work well enough. It is the latest evidence that cracking the code of this complex disease is extremely challenging. We recently did a story on the drug called Alzhemed, the potential AD-drug market and other companies working on treatments/cures at a dementia conference in Washington, DC.
I received a lot of comment on this week's post about the editorial in USA Today about the Food and Drug Administration improving patient access to potentially lifesaving or life-extending experimental drugs and the counterpoint op-ed by FDA commissioner Dr. Andrew von Eschenbach. Lori Gluth writes: "Von E’s commentary appeared to me to be a lame CYA."
In case you hadn't heard September is Prostate Cancer Awareness Month. It's the #2 cancer killer of American men behind lung cancer. The American Cancer Society estimates nearly 220,000 men will be diagnosed with the disease this year. And as the emails coming into our inboxes indicate, it's going to be a busy month for those who are trying to get more money, research and drugs to help fight it.
Late last year, in his first and last interview with CNBC following the blowup of the cholesterol drug torcetrapib, I asked new Pfizer CEO, Jeff Kindler, how he could go from "selling chicken" at Boston Market (he used to run the chain for McDonald's) to "selling drugs". Based on the subsequent vibe I got, it was clear that some of the Pfizer media relations people at the time didn't like the question.
In an editorial today, USA Today calls on the Food and Drug Administration to let dying patients get quicker, easier access to promising, potentially lifesaving or life-extending, developmental drugs. The paper argues that thousands of people in "dire circumstances" deserve "the chance to take a last-ditch gamble".
Novo Nordisk, the world's biggest diabetes drug company, is very lightly traded on the New York Stock Exchange, but check out the move in the stock today. Coincidentally, on the day that The New York Times runs a front-page story (with two jump pages) on how controlling diabetes is about lowering blood sugar and cholesterol levels, the Danish drugmaker is out with major data on its glucose fighting drug Liraglutide.
This has been a lousy summer for investors in Pfizer. The stock traded at nearly 28 bucks in June and today it's fighting its way back up over the $24 mark. Goldman Sachs big pharma analyst James Kelly in a research note to clients is reiterating his buy rating on the shares, but is lowering his 12-month price target from $30 to $29.
On Amgen's conference call the other day regarding the biotech company's cutbacks, officials repeatedly stated that they think the federal government's new, restrictive guidelines for use and payment of Amgen's bread-and-butter anemia drugs will hurt patients and specifically, result in the need for more risky, old-fashioned blood transfusions to treat the condition.
At CNBC we use -- among others -- a couple of primary business news wire services -- NewsEdge, part of Thomson, and Relegence, part of AOL.
Thirty years ago, I was in Las Vegas. My stepmother took me to see Ann-Margret at The Hilton and I remember our waitress telling us that Elvis was the only one who could consistently pack the room. It was strange that he passed away the next day. On this, the 30th anniversary of the King's death from overdosing on prescription drugs, the stocks of the companies that make prescription drugs are having a very dark day.
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.