Ranbaxy to launch generic Actos
JACKSONVILLE, Fla. India’s Ranbaxy Labs will launch a generic version of a diabetes drug in two years, under a patent settlement announced Monday.
The generic drug maker said it reached a settlement with Takeda Pharmaceutical Co. concerning its version of the Type 2 diabetes treatment Actos (pioglitazone hydrochloride). Takeda had earlier filed a patent infringement suit against Ranbaxy when the latter sought regulatory approval from the Food and Drug Administration.
Under the royalty-free agreement, Ranbaxy plans to launch its generic version of the drug in the 15-mg, 30-mg and 45-mg strengths on August 17, 2012. Patents covering the drug expire in 2016.
Actos had sales of $3.4 billion in 2009, according to IMS Health.
Late-stage clinical trial of Avastin fails to meet expectations, Genentech says
SOUTH SAN FRANCISCO, Calif. A late-stage clinical trial of a Genentech drug for men with late-stage prostate cancer has failed, the biotech company announced Friday.
Genentech, part of Swiss drug maker Roche, announced that a phase 3 trial of Avastin (bevacizumab) combined with prednisone and the chemotherapy drug docetaxel did not extend the amount of time that patients survived, compared with chemotherapy and prednisone alone.
The drug already has approval from the Food and Drug Administration for treating tumors and cancers of the lungs, colon, rectum, breasts, kidneys and brain.
Abbott’s submits supplemental approval application for Lupron Depot to FDA
ABBOTT PARK, Ill. Abbott is hoping that the Food and Drug Administration will approve one of its drugs as a treatment for advanced prostate cancer.
The Chicago-based drug maker announced Thursday that the FDA accepted its supplemental approval application for Lupron Depot (leuprolide acetate) in the 45-mg strength. The drug, an injectable, works by suppressing production of testosterone for six months. It is currently available in 7.5-mg, 22.5-mg and 30-mg formulations that work for one, three and four months.
“For many patients with advanced prostate cancer, Lupron Depot is an important treatment option because it can help manage the symptoms of their disease,” Abbott VP global pharmaceutical development Eugene Sun said in a statement. “Abbott is seeking approval for a new six-month formulation to provide greater convenience and dosing flexibility to physicians and patients who could benefit form this medication.”