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Senate HELP Panel Begins Mark Up Of Bill Placing Tobacco Under FDA Oversight
The Senate Health, Education, Labor and Pensions Committee on Tuesday began marking up a bill (S 982) that would allow FDA to regulate tobacco products, CongressDaily reports. The bill would allow FDA to place larger, color warning labels about the health risks of smoking on cigarette packs, as well as to regulate the marketing of tobacco products and advertising to children. The agency could not ban tobacco products or eliminate nicotine from cigarettes, but it could regulate their production and ban flavored cigarettes other than menthol. Sen. Chris Dodd (D-Conn.) said, "Over the years, this bill has been reviewed; it has been vetted; it has been debated, over and over and over again. The time has come to act." The House in April passed its version of the bill, 298-112 (Hunt, CongressDaily, 5/20). The committee by voice vote approved an amendment proposed by Sen. Jeff Merkley (D-Ore.) that would give FDA priority to review products that contain nicotine, such as candies. Committee ranking member Mike Enzi (R-Wyo.) proposed two amendments, one that would have given regulatory authority over tobacco to CDC and another that would have ordered FDA to study which flavors to ban, instead of a current provision that bans specific flavors. Both amendments were defeated. Enzi said, "I think the FDA is the wrong regulator. It approves cures, not poisons." The only Democrat who opposed the bill was Sen. Kay Hagan (N.C.), who said the measure would harm the tobacco industry in her home state (Armstrong, CQ HealthBeat, 5/19). The panel"s other member from North Carolina, Sen. Richard Burr (R), said he would filibuster the bill. He said, "I put my fellow senators on notice: This is something that will be a much longer time on the floor than it will be in this hearing" (CongressDaily, 5/20). The committee plans to continue marking up the bill Wednesday and possibly Thursday.The Obama administration has expressed its support for the bill (CQ HealthBeat, 5/19). FDA Commissioner Margaret Hamburg also has said her agency should regulate tobacco (Armstrong, CQ HealthBeat, 5/18).
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Lexicon's Drug Candidate LX1032 For Carcinoid Syndrome Receives Orphan Drug Designation From EMEA
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has received orphan drug designation from the Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMEA) for LX1032, the company"s oral drug candidate for managing gastrointestinal symptoms associated with carcinoid syndrome. LX1032 is designed to reduce serotonin production in patients with metastatic carcinoid tumors. Elevated levels of serotonin contribute to the gastrointestinal and possibly other symptoms experienced by these patients.
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Victorian Invention A Watchful Approach To Parkinson's
Victorian researchers have developed a wristwatch that continuously monitors the health status of people with Parkinson"s disease to help doctors manage their treatment, Victorian Minister for Innovation Gavin Jennings said today.
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NICE Approves Use Of Lenalidomide In Patients With Multiple Myeloma Who Have Received Two Or More Previous Therapies

Around 2000 multiple myeloma sufferers in the UK could have their lives extended by around three months after a decision by The UK National Institute for Health and Clinical Excellence (NICE) to approve lenalidomide in those patients who have received two or more previous therapies-provided that the cost of cycles beyond the 26th cycle of treatment are met by the drug manufacturer. A summary of the NICE decision is published in a Special Report Online First and in the July edition of The Lancet Oncology. Multiple myeloma is a cancer of the blood cells that form part of the immune system, and is currently incurable. As such, treatment for multiple myeloma is focused on disease containment and suppression. When the manufacturer of lenalidomide (Celgene, UK and Ireland) originally submitted a proposal to NICE containing evidence on the clinical and cost effectiveness of the drug, it was rejected on the basis that is was not cost effective. However, once the company agreed that they would fund treatment beyond the 26th cycle for patients that required it, NICE"s independent evidence review group (ERG) decided that this brought the treatment into acceptable parameters of cost-effectiveness. The committee also considered recent supplementary guidance from NICE to be "taken into account when appraising treatments that might be life-extending for patients with short life-expectancy, and which are licensed for indications that affect a small proportion of patients with incurable illnesses". In coming to its final decision, "the committee noted that, in patients with multiple myeloma who have received two or more previous therapies, life-expectancy without lenalidomide was unlikely to be greater than 24 months, and that lenalidomide could, plausibly, increase survival by more than 3 months compared with dexamethasone. The Committee considered that the possible alternatives to lenalidomide (thalidomide and bortezomib) were unlikely to be routinely available from the NHS. Additionally, it was estimated that around 2000 patients were eligible for lenalidomide treatment under the terms of the appraisal guidance. Therefore, the Committee accepted that the criteria for an appraisal of a life-extending, end-of-life treatment had been met, and that this conclusion was supported by robust data". The Committee therefore recommended lenalidomide, within its licensed indication, as an option for the treatment of multiple myeloma in people who have received two or more previous therapies-when the drug cost of lenalidomide beyond 26 cycles is met by the manufacturer. The Lancet Oncology


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