*Onglyza fails to show cardiovascular benefit in study. *Positive results might have added $1 bln to peak sales. LONDON, June 19- AstraZeneca and Bristol-Myers Squibb's diabetes drug Onglyza failed to reduce heart risks in a large clinical study, disappointing investors who had thought it might demonstrate an edge over rivals.» Read More
After being down about half-a-dollar in early trading, volatile shares of Amgen are trimming their loses and heading back into positive territory at this writing. That turnaround could be from the dissemination of a research note from Wachovia biotech analyst George Farmer.
It's relatively lightly traded and it's a very small market cap (under $500 million), but shares of Sirtris Pharmaceuticals are sitting at a new high in the early going today. The stock has had a very nice move since the end of June when it was trading for less than 10 bucks. Today, it's over $15.
BioCryst Pharmaceuticals drew the short straw, er, needle. The biotech company says a majority of patients in a mid-stage clinical trial of its experimental seasonal and pandemic flu antiviral Peramivir got the drug using too short of an injection needle.
I'm fully aware that this story actually broke yesterday, and was picked up by a couple of competitors, but after receiving today's morning research note from Miller Tabak healthcare analyst Les Funtleyder, I couldn't resist writing this post.
Because it's so extraordinarily rare--if not unheard of--for one analyst to publish research specifically to refute another analyst I thought this is blogworthy. Last Friday, FBR biotech analyst Jim Reddoch told clients in a research note that he was downgrading ImClone Systems to Market Perform in the wake of the robust data released last week on Erbitux...
Recently I blogged about the hiring of a new CEO at ImClone Systems and the unique clause in his contract requiring him to buy half-a-million dollars worth of stock in the company. My suspicion was that ImClone Chairman and billionaire shareholder Carl Icahn had a hand in that.
Yesterday, I blogged that messages to each of David Maris' lawyers seeking comment on Biovail "dropping" or "settling" its case against the former Bank of America Securities analyst had gone without a response. Well, this morning I got this email from one of his attorneys tossing the ball back in Biovail's court:
So, I thought I'd be spending today monitoring the webcast of the FDA Advisory Committees that are meeting to decide whether doctors should use less of the anemia drugs from Amgen and Johnson & Johnson to treat kidney dialysis patients.
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.