By Peter Loftus Abbott Laboratories /quotes/zigman/216393/quotes/nls/abt ABT +0.66% has encountered a delay in its bid for U.S. regulatory approval to expand the uses of its blockbuster anti-inflammatory drug Humira to include treatment of the bowel disease ulcerative colitis. Abbott received a "complete response letter" from the U.S. Food and Drug Administration in late 2011 regarding Abbott's application to market Humira for colitis, spokeswoman Elizabeth Hoff said Monday. The FDA sends such letters when a drug application isn't yet ready for approval. The Abbott Park, Ill., company has provided additional information and continues to have a dialogue with the FDA, Hoff said. Abbott expects an agency decision by the end of this year, she said. She declined to provide contents of the complete response letter. Abbott ... Continue reading →
BY MONICA LANGLEY J.P. Morgan Chase & Co. Chairman and Chief Executive Officer James Dimon had just committed the most expensive blunder of his 30-year career, failing to detect the risk of trades that had begun to generate huge losses at the bank. On April 30, associates who were gathered in a conference room handed Mr. Dimon summaries and analyses of the losses. But there were no details about the trades themselves. "I want to see the positions!" he barked, throwing down the papers, according to attendees. "Now! I want to see everything!" When Mr. Dimon saw the numbers, these people say, he ...BY MONICA LANGLEY J.P. Morgan Chase & Co. Chairman and Chief Executive Officer James Dimon had just committed the most expensive blunder ... Continue reading →
BY JENNIFER CORBETT DOOREN The U.S. Food and Drug Administration on Thursday approved generic versions of blood-thinning drug Plavix. Plavix, marketed by Bristol-Myers Squibb Co. and Sanofi SA, is used to ward off heart attacks and strokes in people with cardiovascular disease, and was among the best-selling drugs in history. The drug's $6.8 billion in U.S. sales last year, as tallied by IMS Health, ranked second behind Pfizer Inc.'s Lipitor, which is used to treat high cholesterol. Plavix's ...BY JENNIFER CORBETT DOOREN The U.S. Food and Drug Administration on Thursday approved generic versions of blood-thinning drug Plavix. Plavix, marketed by Bristol-Myers Squibb Co. and Sanofi SA, is used to ward off heart attacks and strokes in people with cardiovascular disease, and was among the best-selling ... Continue reading →
BY JENNIFER CORBETT DOOREN AND PETER LOFTUS WASHINGTON—A study looking at small group of men with prostate cancer showed the use of Johnson & Johnson's Zytiga eliminated or greatly reduced the size of prostate tumors in one-third of patients treated for six months before surgery. Zytiga was approved last year to treat men with advanced prostate cancer who had not responded to previous chemotherapy. Zytiga is also given in combination with a steroid called prednisone. The company is also studying the drug, which is projected to generate about $1 billion in sales this year, for use at earlier stages of the disease. Data from a mid-stage study ...BY JENNIFER CORBETT DOOREN AND PETER LOFTUS WASHINGTON—A study looking at small group of men with prostate cancer ... Continue reading →
BY RON WINSLOW Pfizer Inc.'s new drug Xalkori for adult lung cancer is showing striking promise against two rare childhood cancers, illustrating how personalized medicine is emerging as a weapon against pediatric malignancies. The drug eradicated the cancer in seven out of eight kids with a childhood form of lymphoma and in two others with a deadly nervous-system cancer called neuroblastoma, researchers reported Wednesday. The medicine also appeared to have a beneficial effect on several patients with a third pediatric tumor. Regardless of their diagnosis, almost all of the children who responded had defects in a gene known as ALK, the same gene ...BY RON WINSLOW Pfizer Inc.'s new drug Xalkori for adult lung cancer is showing striking promise against two rare childhood cancers, illustrating ... Continue reading →
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