Checking Up on the Doctor
Doctors readily dispense prescriptions and advice, but what do they do themselves? A number of surveys, polls and questionnaires provide some clues—and some surprises, writes Melinda Beck. online.wsj.com |
Medtronic Spine Device Draws Concern
The FDA expressed concern about a higher number of cancer cases seen among patients treated with a Medtronic spine device. online.wsj.com |
WHO: Swine-Flu Pandemic Is Over
Nearly 14 months after declaring a new H1N1 flu to be a pandemic, the World Health Organization said that it's over. online.wsj.com |
MEDTOX Scientific Announces Third Quarter Conference Call
[GlobeNewswire] - ST. PAUL, Minn. -- MEDTOX Scientific, Inc. , announced today that it will hold a teleconference to discuss third quarter results on Wednesday, October 13, at 9:30 a.m. Central Time . us.rd.yahoo.com |
How Bad Is the Non-Approval of Arena's Weight Loss Drug?
Derek Lowe submits: Arena (ARNA) released their complete response from the FDA over the weekend, regarding the non-approval of their weight loss drug Lorcaserin. And the arguing has already started about just how bad the news is. There are several levels that this process could be tracking on, and we just don't know which one it's on yet. And the varied regulatory paths that result give you answers to "When will the drug be approved" ranging from "Maybe in six months" through "Maybe in a year" on out to "Maybe in a few years", which at that point shades into "Never". One of the main sticking points is the carcinogenicity data from the animal studies - the FDA is worried, and they want Arena to round up some outside experts to go over the data to address their concerns. Problem is, we don't quite know what that means. It could be anything from "Have some people assure that FDA that everything's actually fine" (the Arena bull position) to "Go run a bunch more long clinical trials" (which is one of the bear positions). I think it's unlikely that the FDA will let the company go through without at least running more rodent studies; I just can't see an outside review of the data doing enough to calm them down. The agency, I believe, is in more of a "Get some people to help you design some good studies" mode.Complete Story » seekingalpha.com |