On The Couch… A Little Weekend Reading
1 CommentBy Ed Silverman // November 1st, 2009 // 1:44 pm
Such a busy pharma world and so little time to keep up, yes? Like you, we always poke around for items of interest, and so we thought we would point out a few you may enjoy from the past week. Think of it as a little bit of catching up. Meanwhile, we hope your weekend is enjoyable and look forward to seeing you again tomorrow…
Amylin Pharmaceuticals and Lilly announced Byetta was approved as a stand-alone med, along with diet and exercise, for type 2 diabetes. Until now, the drug was approved only for patients taking other common diabetes treatments. Tucked away in their statement, they disclosed safety warnings relating to pancreatitis risks and use by patients with severe kidney disease. Six patients taking Byetta died in August 2008 from pancreatitis, prompting an FDA safety alert.
Pfizer is demanding DNA tests for Nigerians seeking to participate in the recent $75 million settlement over its 1996 Trovan clinical trial in Nigeria, which took place during a meningitis epidemic that killed 12,000 children, This Day reports. Nigerian officials charged Trovan caused the death of 11 children and left dozens with disabilities, and Pfizer didn’t obtain proper regulatory approval for the trial and misled parents. Pfizer denied the charges.
The indictment last week of former Stryker Biotech president Mark Philip (see release) has plenty of implications. As The In Vivo Blog notes, the development should “hammer home a message that the FDA and other federal health care enforcement authorities have been delivering for at least two years: senior management at FDA regulated companies can and will be held criminally liable for marketing practices that run afoul of regulators.”
Couch thx to Keko on Flickr Creative Commons
Anonymous
Check this out:
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=ay3S_RW7Bqz8
Bloomberg Article: AstraZeneca’s “Brilinta looks very weak to us now”