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May 14, 2008
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Bristol agrees to co-develop KAI heart drug Biotech firm KAI Pharmaceuticals stands to receive up to nearly $220 million, including $25 million up front, from Bristol-Myers Squibb Co. for the development of KAI-9803, an experimental heart attack drug. The treatment will undergo Phase IIb clinical trials later this year using funds from Bristol-Myers. NJBIZ (N.J.) (5/13) , American City Business Journals/San Francisco (5/13)
FDA chief asks Congress to provide $275M for product safety FDA Commissioner Andrew C. von Eschenbach has sent a letter to Congress requesting up to $275 million to ensure the safety of drugs, medical devices and imported food. Dr. von Eschenbach also detailed the agency's spending plan for measures such as new overseas offices, increased inspections and new databases to monitor drug risks. The letter was written following a request from Sen. Arlen Specter, R-Pa., to discuss how much the FDA needed "to protect the public's health." The New York Times (5/14) Eli Lilly endorses Senate doctor-payment disclosure bill Eli Lilly and Co. on Tuesday backed a Senate bill that would require drug and device makers to report payments and gifts given to doctors, becoming the first pharmaceutical company to support such a measure. An Internet-based national disclosure registry will help boost transparency in the health care system and restore public trust in physician-industry ties, said Dr. Jack Harris, vice president of Lilly's U.S. medical division. The Indianapolis Star (5/13) , The Hill (5/13) IMS Health warns against head-to-head trial of Avastin, Lucentis A $16 million clinical trial comparing Avastin and Lucentis, Genentech's age-related macular degeneration drugs, may benefit payers seeking to minimize the role of drugmakers in clinical trials but could present a disincentive for firms, IMS Health warned on Tuesday. IMS said that although the study could lead to cheaper alternatives to treat AMD, it could also alter the rules of drug development and possibly undermine blockbuster treatments long before they lose patent protection. Financial Times (5/13) FDA relaxes restrictions on ultrasound imaging drugs The FDA has lifted a ban on the use of ultrasound contrast agents in patients with acute diseases, including unstable congestive heart failure. The decision eases warnings imposed last fall on Definity, formerly sold by Bristol-Myers Squibb, and Optison from General Electric Co. William A. Zoghbi, president-elect of the American Society of Echocardiography, lauded the move, saying some recent studies have indicated that the drugs' risk profile is low. The Wall Street Journal (free content) (5/13) Novartis receives FDA warning for Trileptal ad magnets The FDA has asked Novartis AG to stop using a promotional magnet for Trileptal because the risks of the epilepsy drug are printed on the back of the material, where the information is not easily noticed. The drugmaker said the ad was not misleading since the magnet was distributed with Trileptal's complete prescribing data and has not been in use since 2007. CNNMoney.com/Associated Press (5/13)
Study: Abbott's Xience outperforms Boston Scientific's Taxus Patients who received Xience V, Abbott Laboratories' drug-coated stent, were less likely to suffer major adverse cardiac events or undergo repeat procedures compared to those who got Boston Scientific Corp.'s Taxus, according to research data presented Tuesday. The study, which was sponsored by Abbott, is expected to revive shareholder confidence and reassure regulators about the Abbott device's long-term safety. Though Xience has been cleared for use in Europe, it has yet to be approved by the FDA, which is expected to hand down its decision this quarter. The Wall Street Journal (free content) (5/14) , The Boston Globe/Associated Press (5/13) New programs match patients with cutting-edge trials Organizations such as EmergingMed have formulated new programs that match patients to specific clinical trials as part of an effort to address increasing concern about a shortage of medical research participants. Medical ethics experts, however, advise patients to weigh the benefits and risks of trials and caution researchers to respect patients who refuse participation. The Wall Street Journal (free content) (5/14) Study links AstraZeneca's Toprol to stroke, death risks A study of 8,351 patients found that AstraZeneca's Toprol XL, a hypertension drug administered before surgery, cut the risk of a heart attack but heightened the risk of death and stroke. The trial "will be considered by the expert groups that prepare guidelines and recommendations for peri-operative management of patients undergoing general surgery," a company official said. Bloomberg (5/13) Drugmakers prepare to present cancer drug trial results Small and midcap cancer treatment developers on Thursday will release the abstracts of the early-stage and midstage study data they plan to present during the American Society of Clinical Oncology meeting, which will be held May 30 to June 3. Immunogen's Herceptin, Cytokinetics' Ispinesib and Ariad Pharmaceuticals' oral formulation of Deforolimus are among the treatments that will be presented at the event. The Boston Globe/Associated Press (5/13) Plavix does little to help dialysis veins in study Researchers report that Plavix, a blood clot drug from Sanofi-Aventis SA and Bristol-Myers Squibb Co., did not strengthen fistulas, artificial blood vessels created for kidney failure patients undergoing dialysis. The companies, however, said Plavix has not been approved for that use. Bloomberg (5/13) Researchers tie protein to smoking, lung cancer Scientists found that lung cells exposed to cigarette smoke generate less of the FANCD2 protein, leading to DNA damage that causes cells to spread instead of self-destructing as normal cells do. The finding may lead to improved therapies for lung cancer, the researchers said. Yahoo!/Reuters (5/13) |
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