Nearly five years after Congress passed a law enabling future approval of biosimilars, for the first time the FDA has accepted an application to sell a similar, but not identical, version of a biologic drug.» Read More
Bayer and Onyx Pharmaceuticals said they were stopping a late clinical liver cancer trial with Nexavar in the Asia-Pacific region so patients can get the drug sooner after encouraging results.
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.
Pfizer on Wednesday said it named Frank A. D'Amelio, a senior executive of Alcatel-Lucent, as chief financial officer of the drugmaker.
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.
Biotechnology firm Amgen said after U.S. markets closed Wednesday that it will slash its employee base by between 12 and 14% in hopes of reducing its 2008 cost forecasts by $1 billion to $1.3 billion on a pre-tax basis.
Don't listen to the bears - There is a cohort of stocks that is working during this downturn. Here are Cramer's picks.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.
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.
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.