Dec 9- An advisory panel of medical experts on Monday voted to recommend that U.S. health regulators approve an experimental drug for ulcerative colitis and Crohn's disease developed by Takeda Pharmaceutical Co..» Read More
I had planned to blog about the nearly unanimous bearish analyst commentary this morning after Genentech's earnings report yesterday. The biotech giant beat on earnings per share, but came up short on Street expectations for sales of its top four drugs. DNA shares are under pressure again today.
In the wake of Pfizer pulling the plug on its poor-selling inhaled insulin Exubera, the world's biggest diabetes drug company, Novo Nordisk is throwing in the towel on development of its version of inhaled insulin.
The highly anticipated results of the study that goes by the acronym "ENHANCE" are out this morning. You can see what it stands for in the companies' press release. (I wonder how many meetings and brainstorming sessions go into coming up with some of the industry's clinical trial acronyms and abbreviations.)
The brouhaha over the Food and Drug Administration's delay of the potential approval of the prostate cancer drug Provenge from the small biotechnology company Dendreon is now entering the prestigious and credible sphere of peer-reviewed scientific journals.
Even though I'm back on the East Coast today I wanted to share what I think is an interesting anecdote from my time Monday at the JPMorgan Healthcare Conference which is wrapping up in San Francisco.
BioMed Tracker, which closely monitors the clinical trial and drug approval process for investors, is out with a new report today on the Food and Drug Administration's record last year. The drug approval rate went down 13 percent and the number of "approvable letters" went up a whopping 40 percent. An approvable letter has become a euphemism for "delay."
So, imagine my surprise when Amgen put out a press release this morning with new financial guidance. You can read it for yourself here. The release was issued in conjunction with the company's presentation at the JPMorgan Healthcare Conference.
After the closing bell Monday, Genzyme and Isis Pharmaceuticals announced a blockbuster deal that set the overcrowded halls abuzz here at the JPMorgan Healthcare Conference. They're partnering on an Isis drug in late-stage development for cholesterol. It's a once-a-week injectable for people who don't get their cholesterol low enough taking a statin like Lipitor, Crestor or Zocor.
Okay, the real "Granddaddy of 'em all" was actually this past Tuesday at the Rose Bowl (I promise that's my last reference to the amazing USC Trojans unless they win a split national championship), but the granddaddy of healthcare investment conferences begins on Monday in San Francisco.
In a research note to clients this morning, Miller Tabak healthcare analyst Les Funtleyder writes about the FDA news I blogged about yesterday regarding Amgen's anemia drugs. He says, "...we believe the major 'leg down' in usage (of the anemia drugs) was last year and more studies assuming no major new negative revelations will only serve to continue deterioration but at a decelerating rate."
The Food and Drug Administration late this morning put out a news release with the heading, "FDA Receives New data on Risks of Anemia Drugs." This is more bad news for an additional population of cancer patients and, of course, Amgen and, to a lesser extent, Johnson and Johnson.
Pfizer sent out a press release this morning touting the findings of a company-sponsored European survey of ex-smokers. The study found that 84 percent of the respondents in France, Germany, Italy, Spain and the UK who had consulted with a doctor or some other healthcare professional about quitting thought it was helpful.
The "Dendreonians" have probably already seen it, but I wanted to call your attention to a pretty long piece that ran in the health section of the Los Angeles Times on Dec. 31st. It's about the grass-roots movement to get Dendreon's prostate cancer drug, Provenge, approved by the FDA. Here's the link.
The seven biggest stories in my sectors in 2007? Avandia, Dendreon, Pfizer, Biogen were just a few of the topics that made this a fascinating year for the pharmaceuticals and biotechnology industries.
A Merrill Lynch research note to clients titled, "Diabetics scared off therapy," contains some interesting observations about what's happened to the oral diabetes drug market in the wake of the Avandia safety scare earlier this year.
Shares of drugmaker Wyeth could remain under pressure this day after Christmas. At least two analysts are suggesting that Wyeth could be under assault by another generic drug company.
Yes, I'd rather be blogging about another topic by now, but I hope this will be the last entry -- at least for awhile -- on the Avastin vs. Lucentis story. You see, last Friday I got repeatedly voice-mailed and e-mailed by Christine Castro, the new head of corporate communications/media relations at Genentech...
So, it didn't take long after my Genentech blog entry got posted yesterday for me to receive an email and a voicemail from a Genentech spokesperson requesting a "clarification" on my take regarding the latest chapter in the Avastin vs. Lucentis brouhaha. I think I'm being spun.
Genentech today has essentially backed down from a proposed crackdown on doctors' use of the cancer drug Avastin instead of the way more expensive Lucentis. The drugs are used to treat age-related macular degeneration (AMD, for short), which is the leading cause of blindness in adults.
Most of my PR and professional contacts send Christmas cards, but for the past two years the boutique Wall Street firm, Rodman & Renshaw, has sent me heavy metal piggy banks. I assume the company sends them to its clients as well.