Monday, October 11, 2010

A.M. Vitals: Jazz Pharma’s Fibromyalgia Drug Needs More Studies

FDA Says No: Jazz Pharmaceuticals said the FDA won’t approve its fibromyalgia drug in its current form and that the therapy needs more trials, Dow Jones Newswires reports. In August an FDA panel voted against recommending the drug — already available under the Xyrem brand name to treat narcolepsy, but distributed under heavy restrictions — in part because of its potential as a street drug. An illegal form of the medication is similar to the “date rape drug” GHB.

Jaundice Connection?: A study published in Pediatrics finds an association between jaundice in newborns and the development of autism, but doesn’t show that one causes the other, the Associated Press reports. The Danish study found a 9% incidence of jaundice among infants who went on to develop autism, compared to a 3% incidence among those who didn’t. Other studies have found no link.

Drug Pricing: Novartis has put a price tag on its newly-FDA-approved oral MS drug Gilenya: about $48,000 a year, the WSJ reports. The first oral therapy for the disease approved in the U.S. is more expensive than current therapies, which are delivered by injection or infusion and top out at about $40,000, the paper says.

Weighing ACOs: Accountable care organizations — providers teaming up to deliver more integrated care that is hopefully both better and cheaper — are the latest fad in health care, and various interests are trying to suss out their potential impact, Kaiser Health News reports. Because providers will be incentivized to hold down costs, medical-device makers, for example, are worried cheaper devices will be favored, regardless of what’s most appropriate for a given patient. Employers, meantime, are concerned that costs may rise as large providers increase market share, KHN says.

Image: iStockphoto


View the original article here

No comments:

Post a Comment