Dong-A wants you to stay up,

if you know what I mean. But, I have to give them a heartfelt congratulations on their “positive results” for their new “long-acting” drug. I’m glad they met all their “endpoints.”
Technorati Tags: pharmaceuticals

Silver-tongued execs or gullible shareholders?

Somehow this just strikes a sour chord with me. I mean, any clinical trial in the development of a drug is a gamble. The odds are worse than high-stakes poker.
The kicker: Nuvelo expects further similar suits. I smell a rat.
Technorati Tags: drugs, pharmaceuticals

After that, you will die of a heart attack

I have no idea what this is all about. With 4 grams of transfat per doughnut, I think I’ll be gagging over the toilet rather than, well, just click the link.
h/t apostropher, who else?
Technorati Tags: Krispy Kreme

While I lay here sick, I speculate on the future of my industry

Of course we are all a bit concerned about job security. So it’s been with a bit of interest that I’ve been keeping an eye on Eye on FDA and other pharma blogs to catch up on the latest of drug development legislation, industry pipelines, and anything else that might affect the industry. Granted, I’m [...]

Ch-ch-changes

We have a new party in charge of the houses, and many have anticipated that this would bring changes in the way we develop and market drugs. And the potential is there. Eye on FDA summarizes new legislation.
Quick thoughts:

Kennedy-Enzi – yes, the FDA needs greater authority for post-marketing enforcement, and I’m glad to see it [...]

Please ILLUMINATE me on these questions

So, now that Pfizer has discontinued development of its star candidate, I have a couple of questions about this trial, mostly concerning the size of the trial.
Why 7500 patients per arm?
For example, this trial is sufficient to detect, with 95% confidence, an adverse event that has an occurrence rate of 1 in 2500 = 0.0004. [...]

Pfizer drops the bomb on investors

A mere 3 days after painting a rosy outlook for investors and talking about its “robust drug pipeline,” Pfizer killed development for its star candidate due to an unexpected number of deaths and “cardiovascular events” (usually heart attacks or other serious heart damage). This is the drug for which Pfizer released information about elevated blood [...]

Other trends that affect clinical research

Lilly is “outsourcing”:http://pharmagossip.blogspot.com/2006/11/lilly-say-ta-ta-to-jobs-in-west.html jobs to India. This is nothing new; pharma companies often outsource their clinical trial operations and analysis, but what is interesting about this move (besides the fact it comes on the heels of a similar announcement by Novartis) is one of the reasons given:
bq. “The goal of our relationship with TCS has [...]

Tea leaf reading for clinical research

Now that the Democrats have taken over Congress, a lot of analysts (professional, amateur, and armchair) have tried to noodle out what this means for Big Pharma. And, of course, whatever happens to Big Pharma is going to impact what’s going to happen in clinical research.
“Forbes”:http://www.forbes.com has examined “six pieces of legislation”:http://www.forbes.com/2006/11/16/fda-congress-bills-biz-cz_mh_1116fda.html?partner=yahootix that Democrats are [...]

More autism news

Recently J&J’s Risperdal, a drug formerly approved to treat schizophrenia, was approved to treat irritability symptoms stemming from autism. A group has taken issue with the ruling, claiming that the risks (including the risk of tardive dyskinesia) outweigh the benefits.