Adderall 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...

Impax Laboratories says the FDA has formally turned thumb's down on Vadova, its experimental Parkinson's drug. In a release, the company said that the nonapprovable letter stated that the agency was Read more...

> Shire says that the FDA has told the company that it hasn't been able to make a decision on its concerns that copycat versions of Adderall XR are too easy to produce. Shire wants the agency to require more rigorous bioequivalence testing. Report

> Iceland's Actavis has raised its bid for Pliva by 11 percent. …

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> The FDA has agreed to give priority review for Revlimid as a treatment for cancer of the plasma cells found in bone marrow. Report

> The lead-poisoning drug Endrate has been linked to the death of two children. Report

> A hedge fund that holds nine percent of Chiron's stock …

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A federal advisory panel is suggesting that the FDA should require its toughest warning label for ADHD drugs like Ritalin. The recommendation came as a surprise to the FDA, which typically follows the advice of its advisory panels but isn't required to. One possible follow-up would be for the FDA to ask for advice from a separate panel. At issue are reports of heart disease that may be linked to the drugs. The agency has track the deaths of 25 people and 54 cases of serious cardiovascular …

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An FDA committee is scheduled to meet in a week to review how the agency should best study the cardiovascular risks posed by ADHD drugs. Concerns were heightened by Canada's decision to pull Adderall XR from the market last year. Report

Shire has settled a patent dispute with generic drug maker Impax for the attention-deficit disorder drug Adderall XR. Under the terms of the settlement, Impax's generic version of the drug will be allowed to enter the market as of 2010. Shire will receive royalties on all sales. The company is still in litigation with Barr Laboratories over Adderall XR. "We are very pleased to have resolved the lawsuits against Impax. The settlement terms are consistent with our beliefs that Shire's …

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> Canada's Vasogen said that the biggest of its ongoing Phase III trials for Celacade for heart failure will be completed by the end of the year. Report

> Viventia Biotech of Toronto has struck a deal to go private. Report

> Merck has received FDA approval to …

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Seeking to protect its market for the hyperactivity drug Adderall XR, Shire Pharmaceuticals filed a Citizens Petition asking regulators to require any generic competitor to demonstrate its equal effectiveness from the patient's perspective. That kind of testing requirement would likely delay any approval of a copycat competitor. A group of generic drug makers, including Teva, have filed abbreviated new drug applications for generic Adderall XR. Adderall XR represents half of Shire's …

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The UK's Shire Pharmaceuticals says that it has received the approval of Health Canada to reintroduce Adderall for the treatment of hyperactivity disorder. Evidence that some patients taking Adderall suffered sudden death and strokes prompted Canadian officials to suspend the drug earlier this year. The FDA limited its response to changing the label for Adderall to warn against its use by adults or children with heart defects.

"Adderall XR is a safe and effective treatment for …

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