International Business News - FDA http://www.ibtimes.com All articles are copyrighted by IBTimes.com 400 100 http://www.ibtimes.com/ http://www.ibtimes.com/images/top_logo_ibt2_3.gif Biotechnology company Amgen Inc. said Wednesday the Food and Drug Administration will not issue a much anticipated decision this week on whether to approve an experimental blood-clotting disorder drug. http://www.ibtimes.com/articles/20080723/amgen-blood-clotting-drug-decision-delayed.htm Wed, 23 Jul 2008 10:27:28 EDT NexMed Inc. said Tuesday the Food and Drug Administration rejected its application for an experimental topical treatment for erectile dysfunction. The rejection in the form of a "nonapprovable letter" referred to potential issues in a study performed on mice to test whether the experimental product is carcinogenic. That study was completed in 2002 and the company said it doesn't have to conduct that trial again. http://www.ibtimes.com/articles/20080722/nexmed-erectile-dysfunction-drug-gets-rejected.htm Tue, 22 Jul 2008 18:48:14 EDT The Bush administration strongly opposes legislation to give federal health authorities the power to regulate tobacco products, a top official said in a letter to Congress obtained by The Associated Press on Tuesday. http://www.ibtimes.com/articles/20080722/bush-administration-opposes-tobacco-regulation.htm Tue, 22 Jul 2008 18:54:43 EDT The Food and Drug Administration has unveiled a plan for recruiting young staffers to replace the hundreds of scientists retiring from the agency. The FDA said Thursday it will launch a two-year fellowship program for physicians, chemists, statisticians and other science professionals interested in food and drug regulation. About 30 to 40 fellows will be accepted for the first program, which begins in October. Some of those accepted are expected to stay on as full-time employees after completing the program, which includes course work and seminars. http://www.ibtimes.com/articles/20080718/fda-unveils-plan-to-recruit-young-science-staffers.htm Fri, 18 Jul 2008 08:43:28 EDT Specialty pharmaceutical company Sciele Pharma Inc. said Wednesday the Food and Drug Administration asked for more information on its experimental head lice treatment. http://www.ibtimes.com/articles/20080716/sciele-gets-fda-request-for-info-on-lice-treatment.htm Wed, 16 Jul 2008 16:21:40 EDT Biotechnology company Genentech Inc. ended several studies combining its cancer drug Avastin and Pfizer Inc.'s Sutent because several patients developed a type of anemia. http://www.ibtimes.com/articles/20080714/genentech-ends-studies-on-drug-combo-safety-issue.htm Mon, 14 Jul 2008 18:35:50 EDT Biotechnology company Amgen Inc. said Business Wire erroneously released a statement from the company Monday, saying the Food and Drug Administration approved its Nplate treatment for a rare type of blood-platelet deficiency condition. http://www.ibtimes.com/articles/20080714/amgen-gets-fda-approval-for-platelet-disorder-drug.htm Mon, 14 Jul 2008 12:19:16 EDT Chip maker Intel Corp. said Thursday it received market clearance from the U.S. Food and Drug Administration for its in-home personal health system. The Intel Health Guide is a care management tool for health care professionals who manage patients with chronic conditions. http://www.ibtimes.com/articles/20080710/intel-gets-fda-clearance-on-in-home-medical-device.htm Thu, 10 Jul 2008 13:17:30 EDT Pfizer Inc., the world's largest drug maker, is trying to persuade government regulators not to add stern warnings about suicide risks to its best-selling epilepsy drug. http://www.ibtimes.com/articles/20080709/fda-panel-to-weigh-suicide-risks-of-epilepsy-drugs.htm Wed, 09 Jul 2008 17:07:03 EDT ViroPharma Inc. said Tuesday an upcoming Food and Drug Administration advisory committee meeting will focus on general generic drug issues and not specifically on the company's only marketed treatment, Vancocin. http://www.ibtimes.com/articles/20080708/viropharma-fda-committee-will-have-generics-focus.htm Tue, 08 Jul 2008 10:52:14 EDT Drug developer Biopure Corp. said Monday it will file a study plan for its experimental blood substitute Hemopure with the Food and Drug Administration, months after the agency was criticized for its lack of action on potential safety risks associated with synthetic blood products. http://www.ibtimes.com/articles/20080707/biopure-plans-blood-substitute-study.htm Mon, 07 Jul 2008 10:56:22 EDT Generic drug maker Mylan Inc. said Thursday it received tentative approval from the Food and Drug Administration to market its 600 milligram linezolid tablets. http://www.ibtimes.com/articles/20080703/mylan-gets-fda-ok-to-market-generic-antibiotic.htm Thu, 03 Jul 2008 08:06:53 EDT Drug developer and medical device maker Abbott Laboratories said Wednesday it received Food and Drug Administration approval for its anticipated drug-coated stent, Xience V. http://www.ibtimes.com/articles/20080702/abbott-gets-fda-approval-for-drug-coated-stent.htm Wed, 02 Jul 2008 17:36:49 EDT Johnson & Johnson's blockbuster anti-psychotic drug Risperdal will face generic competition, as Teva Pharmaceutical Industries Ltd. on Monday became the first company to receive approval for a generic version. http://www.ibtimes.com/articles/20080630/teva-receives-fda-approval-for-generic-risperdal.htm Mon, 30 Jun 2008 17:48:13 EDT GlaxoSmithKline PLC said Monday it responded to questions raised by the Food and Drug Administration over the cervical cancer vaccine Cervarix and will provide the agency with more complete late-stage study data in 2009. http://www.ibtimes.com/articles/20080630/glaxosmithkline-responds-to-fdas-cervarix-query.htm Mon, 30 Jun 2008 11:56:05 EDT A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Commerce Committee. http://www.ibtimes.com/articles/20080627/house-committee-criticizes-fda-over-bonuses.htm Fri, 27 Jun 2008 08:16:54 EDT A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Commerce Committee. http://www.ibtimes.com/articles/20080626/committee-critical-of-fda-bonuses.htm Thu, 26 Jun 2008 19:26:13 EDT Warner Chilcott Ltd. said Monday the Food and Drug Administration approved a 150 mg strength of Doryx delayed-release tablets as a treatment for severe acne. http://www.ibtimes.com/articles/20080623/warner-chilcott-gets-fda-ok-for-150-mg-acne-drug.htm Mon, 23 Jun 2008 08:39:34 EDT Drug developer Ligand Pharmaceuticals Inc. said after the bell Friday the Food and Drug Administration will take an additional three months to review its experimental blood-clotting drug Promacta. http://www.ibtimes.com/articles/20080620/ligand-says-fda-extends-blood-clot-drug-review.htm Fri, 20 Jun 2008 16:31:25 EDT Despite previous warnings to physicians, drugs used to improve medical images of the heart continue to be linked to serious side effects and some deaths, regulators said Friday. http://www.ibtimes.com/articles/20080620/fda-says-deaths-with-heart-imaging-drugs-continue.htm Fri, 20 Jun 2008 16:25:23 EDT