FDA Approvals - Basilea Reports Positive Phase III Results for Alitretinoin (PrimeNewswire via
Basilea Reports Positive Phase III Results for Alitretinoin (PrimeNewswire via Yahoo! Finance)
BASEL, Switzerland, Feb. 19, 2007 -- Basilea Pharmaceutica Ltd. announced today that its placebo-controlled pivotal phase III BACH trial successfully met its primary objective. Alitretinoin was effective in patients suffering from severe and refractory chronic hand dermatitis, as determined by the stringent endpoint of clear and almost clear hands.
Ranbaxy Says FDA Searched Offices, Lab (AP via Yahoo! Finance)
U.S.-based subsidiaries of generic drug developer Ranbaxy Laboratories Ltd. of India said Thursday that federal agents have searched their offices and manufacturing facility in New Jersey.
Merck asks for additional Januvia OK (Sharewatch)
Januvia is already approved to treat type 2 diabetes. The company is asking the FDA to add approvals for use as an initial and add-on therapy for glycemic control. Merck said it expects a decision by mid-October.