ADHD news from FierceBiotech

Eli Lilly has won FDA approval of Strattera, a therapy designed to treat ADHD. Lilly says this is the first regulatory win for a non-stimulant ADHD drug in a market dominated by two Read more...

The blogster Eye on FDA has tracked down and posted every Read more...

Cortex Pharmaceuticals says that the FDA has turned thumbs down on its INDA for a Phase IIb trial of CX717 for ADHD after reviewing its animal toxicology studies. Cortex says its asking FDA Read more...

Noven will pocket the second of three potential $25 million milestones outlined in its deal with Shire. Shire says that the ADHD drug Daytrana continues to rack up enough market share to trigger the Read more...

Cortex Pharmaceuticals says it will resume a study of its lead drug for Alzheimer's after getting a green light from the FDA. The agency put trials of CX717 on hold last year after it voiced concerns Read more...

Pfizer has licensed the diagnostic rights involved in the genetic research of Genizon BioSciences in Alzheimer's, ADHD, and endometriosis. Pfizer is providing an unspecified upfront fee, research money and an equity investment. Genizon is retaining the therapeutic rights associated with its research on the Quebec Founder Population, which is being used to develop genetic markers to predict the risk of disease.

"We are excited about the broad scope and combined contributions of this …

Read more...

> The FDA has issued its second approvable letter for Shire's ADHD drug Vyvanse. Report

> Galapagos has acquired ProSkelia, a French subsidiary of ProStrakan in a deal worth up to €45 million. Report 

> Allergan has announced that the FDA has asked for more data on its eye pressure …

Read more...

The FDA has ordered drug makers to warn physicians away from prescribing stimulants like Ritalin, Adderall and Concerta to adults and children with heart problems, according to a report in The New York Times. The agency is also warning that the drugs are linked to hallucinations experienced by one in a thousand children. "We're not trying to scare people out of using these drugs," said Dr. Robert J. Temple, director of the Office of Medical Policy at the drug agency. "Still, I …

Read more...

Cephalon's last bid to gain approval for its ADHD drug Sparlon was rejected by the FDA and the news helped push its shares down 12 percent in early trading. The FDA's formal rejection was heavily influenced by its concern that the drug may have caused a case of Stevens Johnson syndrome, a rare and deadly skin disorder. That same link was enough for an FDA expert committee, which had rejected Sparlon by a vote of 12 to 1. Sparlon is marketed as a therapy for narcolepsy under the brand name …

Read more...

Shares of Cortex Pharmaceuticals got hammered on Wednesday when the company announced that a Phase II study to determine its lead drug's effect on wakefulness failed to demonstrate a greater effectiveness than a placebo. The study simulated night shift work among subjects taking CX717 and was funded by the Defense Advanced Research Projects Agency. The results differed markedly from an earlier study, and Cortex says a difference in the way the studies were designed may have played a role …

Read more...