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Management Change At Actelion - Isaac Kobrin To Take Newly Created Position Of Chief Medical Officer
Actelion Ltd (SIX: ATLN) announced the creation of the position of Chief Medical Officer (CMO). This change was initiated to fulfill the needs of a fast growing organization, which is developing products rapidly and managing a growing portfolio. Effective 1 July 2009, the current Head of Clinical Development, Isaac Kobrin will move into this position. He will continue to be a member of Actelion"s Executive Committee (AEC).
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This Time Around, Debate Much Different
Insurance companies, "the industry that gets credit for helping to kill the Clinton administration"s health care overhaul 15 years ago," are now "striking a conciliatory tone as it faces the most serious attempt to overhaul the system since that effort collapsed," CQ Politics reports. With low favorability ratings and Democrats in control of the federal government, "insurers know they aren"t in a good bargaining position" this time around. They have already offered concessions, including providing "insurance in the individual markets to everyone, without regard to who is sick," and not "charging people who are ill higher rates and cut health care costs." But they"ve also been ""careful to structure their offers in such a way that appears significant but does not overpromise." An individual mandate for all Americans and an end to health screening for applicants could offer "a win-win outcome, one that will benefit not just patients but potentially the profits of the industry as well." But "perhaps the biggest motivation for insurers to deal now is that they fear what might happen if they don"t" - the "creation of a government-run plan that would be more attractive to the public and siphon off customers" (Adams, 6/1).
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OSI Pharmaceuticals Announces Acceptance Of Tarceva Supplemental New Drug Application For Review By The U.S. Food And Drug Administration
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental New Drug Application (sNDA) for the use of Tarceva® (erlotinib) as a first-line maintenance treatment for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy. Based upon the March 17th receipt of filing the FDA Prescription Drug Fee Act (PDUFA) review date will be on or about January 18, 2010.
Public Health

FDA Approves Besivance To Treat Bacterial Conjunctivitis

The U.S. Food and Drug Administration approved Besivance (besifloxacin ophthalmic suspension 0.6 percent) for the treatment of bacterial conjunctivitis (non-viral), a contagious condition marked by irritation of the eyes and a discharge from the mucous membranes. "Bacterial conjunctivitis is a common condition that affects people of all ages," said Wiley A. Chambers, M.D., acting director of the Division of Anti-Infective and Ophthalmology Products in FDA"s Center for Drug Evaluation and Research. "It is important to have a variety of treatment options available to health care professionals and patients because an effective drug therapy can reduce the duration of the illness and reduce the chances of infecting others." Bacterial forms of conjunctivitis are common in childhood, but they can occur in people of any age. Symptoms of bacterial conjunctivitis can include red eyes, swelling, eyelids sticking together, itching, watering and a white or yellow sticky discharge from the eyes. Bacterial conjunctivitis is generally a condition that runs its course in 7-14 days. Patients using the drug in clinical trials had a faster rate of resolution of the infection than those treated with a solution containing only a preservative. The drug was shown to be effective in treating patients age one year and older. Adverse events were reported in less than 3 percent of patients in clinical trials. Adverse reactions included redness of the eyes, blurred vision, eye pain, irritation and itching, and headache. Besivance is an eye drop for topical use on the eyes only. It should not be injected into the eye. Besivance is made by Bausch & Lomb, Rochester, N.Y. U.S. Food and Drug Administration


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