Last weeks resignation of Dr. Ronald Farkas, who supervised the FDAs clinical review of eteplirsen, advocated for a placebo-controlled trial, and publically expressed doubts about Sareptas clinical study, appeared to clear the way for the FDAs accelerated approval.
Date: Sep 19, 2016
Category: Health
Source: Google
FDA approves first drug to treat rare form of muscular dystrophy
Sareptas stock price jumped 90%Monday after the approval was announced. The companys stock also got a bounce last week after the FDA confirmed a staff member who had been critical of the drug, Dr. Ronald Farkas, hadleft the agencyfor another job.
Date: Sep 19, 2016
Category: Business
Source: Google
In setback, a majority of FDA experts reject Sarepta's emotional campaign to gain Duchenne
There are "reasons to be concerned this was not an appropriate control to pick, noted the FDAs Ronald Farkas, highlighting how investigators improperly compared dystrophin levels in different types of muscles.
Date: Apr 26, 2016
Source: Google
Still tired after sleeping? You might have sleep apnea
No drugs have been approved to treat sleep apnea, said Dr. Ronald Farkas, a neuroscientist in the FDA's Center for Drug Evaluation and Research. Doctors sometimes prescribe drugs to help people with daytime sleepiness caused by sleep apnea, but these medications do not treat sleep apnea.
There are no drugs that are approved by the FDA to treat sleep apnea. Ronald Farkas, M.D., Ph.D., at FDA's Center for Drug Evaluation and Research, says that doctors sometimes prescribe drugs that promote wakefulness such as Provigil and Nuvigil for patients suffering from the daytime sleepiness cau