Pharmalot… Pharmalittle… Evening Edition
Make a commentBy Ed Silverman // February 6th, 2008 // 6:44 pm
Busy, busy. As always. There was so much coming over the transom today that we simply couldn’t get to all of it. And so we hope to bring you more interesting items in the morning. For now, these tidbits are fresh. So enjoy and have a good night…
An FDA panel voted 10-0 that a longer-lasting version of Lilly’s Zyprexa antipsychotic is safe and effective, but the drugmaker should do more studies to determine why some patients experience excessive sleepiness. Despite such concerns, the committee stopped short of calling for a Black Box warning, according to the Associated Press. The endorsement comes as Lilly negotiates with federal and state prosecutors over charges off improper marketing of the widely used pill. A $1 billion fine may be paid.
A judge has refused to grant a new trial or overturn a $99 million judgment against Wyeth, but has agreed to consider whether the punitive damages the jury awarded three Nevada women in October were excessive, the Associated Press reports. A hearing will be held in Reno, Nevada, on Feb. 14 to hear arguments about the basis for the punitive damages and evidence used to support $35 million in compensatory damages. The three women claimed Wyeth’s Prempro caused their breast cancer.
Thirteen of the 20 best-selling prescription drugs in the US come from manufacturing plants on Puerto Rico. But an investigation by the Associated Press has found dozens of examples over four years of lapses in quality control - a review of 100 pages of FDA reports shows facilities have failed to keep labs sterile and have exported tainted pills. Meanwhile, pharma operations on the island churn out $35 billion of drugs each year, most of it for sale as part of the $300 billion market in the US.