A senior official within FDA told Reuters the agency would consider proposals for providing treatments under special emergency new drug applications, if the benefits of the treatment outweighed the potential safety risks. The hold prompted a North Carolina physician with family members in West Africa to say enough.» Read More
When Schering-Plough Chairman and CEO Fred Hassan recently decided to buy another $2 million worth of SGP shares in the wake of the Vytorin study takedown, the company put out a press release.
Recently I've blogged and raised the question in an interview about whether Onyx Pharmaceuticals might be having a tough time finding a new leader. Well, nearly six months since longtime Chairman and CEO Hollings Renton announced his plans to retire this year, the biotech company has filled the spot.
I often get pitched by PR people who want me to do a story on their micro-cap biotech company. And I almost always turn them down. I know that most of the sector toils in the eight and nine digit market value space and that there's a bit of a Catch-22 at work.
According to The Center for Responsive Politics' web site Pfizer Chairman and CEO Jeff Kindler has opened his wallet again for Sen. Hillary Clinton. You can see his latest "give" here. Twice now within the past year Kindler has given the maximum amount ($2,300) an individual can contribute to a candidate.
I always prefer it when pharmaceutical/biotech execs and analysts can break out of their scientific/financial jargon and give good soundbites or quotes. So, among the flurry of research notes I've received over the weekend and this morning on the Genentech Avastin news the award goes to Rodman & Renshaw's Mike King who writes, "The biotech leader has its groove back."
Shortly before the closing bell trading in shares of Genentech was halted for news pending. Then, right after the bell the company issued this press release announcing the Food and Drug Administration has granted "accelerated approval" to Genentech's Avastin for use on breast cancer.
As we sit here closely monitoring the wires and waiting for word out of Genentech and/or the FDA about a decision on Avastin for breast cancer, it seemed like as good a time as any to once again post some samples of a flood of recent emails from readers--the good, the bad and the ugly.
The results of the controversial study called "Enhance" of the cholesterol drug Vytorin from Merck and Schering-Plough will not be presented as a prestigious "late breaker" at the upcoming annual meeting of the American College of Cardiology.
Who needs Oscar ballots? Biotech investing wonks/nerds (and I'm not suggesting I am one) might wanna start an office pool about when and what the FDA's decision will be on Genentech's drug Avastin for breast cancer.
The world's biggest drug company is spending chump change to take out a little biotech at a 118 percent premium. Pfizer, which has a cash hoard of more than $20 billion, is plunking down a paltry (for Pfizer, that is) $195 million in cash money to buy Encysive Pharmaceuticals.
Almost exactly one year since Onyx Pharmaceuticals announced positive results of its drug Nexavar for liver cancer and the stock doubled in one day, the biopharmaceutical company is providing an example of the ups and downs of drug development and biotech investing.
Even though I'm off today I, like a lot of folks, couldn't help checking my landline voicemail at work. And much to my surprise one of the messages was from Mark Gottlieb, the Chief Compliance Officer at Visium Asset Mgt. I referred to him in yesterday's post.
Taking an extra day off to extend the long weekend before we go into a very busy period. Possibly a week from today (Friday) Genentech could get word from the Food and Drug Administration on its cancer drug Avastin for breast cancer. The agency could approve it, reject it or delay making a decision.
Early today a press release and headlines were crossing the wires about Dendreon announcing positive test results on its controversial prostate cancer drug, Provenge, at an oncology conference in San Francisco.
This morning we did back-to-back interviews on "Squawk Box" with the author of the New York Magazine article about his experience on the smoking cessation drug Chantix and a Pfizer exec to respond to it. You can watch the segment in the video clip.
Not long after I submitted my last post I got word that the House Energy and Commerce Committee sent a letter today to the four Congressmen who had requested a hearing into the Dendreon/Provenge saga. And the answer is "no." The stock, which had been rallying on heavy volume today, sank when we broke the news on "Closing Bell."
There was a mini-rally and spike in volume in shares of good ol' Dendreon this morning and early afternoon. The run-up occured ahead of CEO Dr. Mitchell Gold's presentation at the BIO CEO conference in New York City at 1:15 ET.
After the closing bell yesterday Genentech popped out a stock-moving press release. The world's most highly-valued biotech announced that its drug Avastin when used in combo with Sanofi-Aventis' chemo drug, Taxotere, helped women with a certain type of aggressive, advanced breast cancer live longer without the disease getting worse.
The current issue (February 18, 2008) of New York Magazine has a story that it teases on the cover above the masthead, "No Smoking Wonder Drug." Below it in drug-label fine print the sub-head is: "Makes quitter talk to potted plants."
Schering-Plough is bringing up the rear of big pharma earnings season this morning--it reported later than normal because it apparently took longer to do all the accounting for a big acquisition--with a beat on the top and bottom line. But investors, as is usually the case, are more concerned about guidance.