Legislators accuse Vytorin partners of creating secret report
WASHINGTON Reps. John Dingell, D-Mich., and Bart Stupak, D-Mich., have accused Merck and Schering-Plough of creating a secret report on the drug Vytorin for the Food and Drug Administration.
The two congressmen are investigating a possible link between the drug and cancer risk. In a letter, they have accused Sir Richard Peto of creating a secret report for the FDA and misrepresenting its contents to the congressmen’s staff. Peto was the lead researcher in a study on Vytorin (ezetimibe and simvastatin) that appeared in The New England Journal of Medicine.
The study links the drug to an increased risk of death from cancer, but the journal’s editorial says that the increase was due entirely to chance, as the incidence of cancer itself did not increase.
Teva’s Azilect slows Parkinson’s disease in trials
WASHINGTON Results from a Phase III clinical trial have shown that Teva Pharmaceutical’s Azilect 1-mg tablets can slow the progression of the disease, the drug maker announced.
Researchers gave 1,176 Parkinson’s disease patients daily 1- to 2-mg doses of Azilect for 18 months or a placebo for the first nine months and the drug for the second nine months.
Patients who took the 1-mg dose of Azilect showed significant improvement compared with patients in the placebo group.
The Food and Drug Administration approved Azilect in May 2006 as a monotherapy for early-stage ParkinsonOs disease and as an adjunct therapy to levodopa in moderate-to-advanced stages of the disease.
The drug, known generically as rasagiline mesylate, is available in 30 countries. Danish drug maker Lundbeck markets it in Europe, and both companies plan to co-promote it in the United Kingdom, Germany and France.
Taro to ask for extension on Sun Pharmaceuticals’ offer
TEL AVIV,, Israel Taro Pharmaceutical Industries has said it will appeal to Israel’s Supreme Court to contest a ruling in the Tel Aviv District Court regarding India-based Sun Pharmaceuticals’ offer to acquire the Israeli generic drug maker.
The District Court judge had called Taro’s demand for a tender offer from Sun disingenuous, considering Taro’s acceptance of the offer a year ago.
Taro plans to ask the Supreme Court to extend the deadline for Sun’s offer, which was Tuesday at 5 p.m.