Ariad Pharmaceuticals Inc., the cancer-drug maker that had lost about 70 percent of its value this year, will return its only product to the U.S. market after regulators approved a new prescribing and risk management plan. The shares jumped 16 percent.
Johnson & Johnson and Pharmacyclics Inc. won U.S. approval for their breakthrough therapy to treat a rare blood cancer, becoming the second drug to gain marketing clearance under the process created to speed new medicines to seriously ill patients.
Aveo Pharmaceuticals Inc. failed to win the backing of U.S. regulatory advisers for its lead product candidate, a kidney cancer drug, after the panelists questioned whether it was as effective as existing treatments.
Roche Holding AG’s Perjeta won expanded U.S. approval as the first pre-surgical therapy in breast cancer, increasing the odds the disease may be stopped in those diagnosed with early stage HER2-positive tumors.