Food And Drug Administration News
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Merck & Co.’s experimental insomnia drug, meant to be a less disruptive alternative to Sanofi’s Ambien sleeping pill, is safe only at lower doses, U.S. regulatory advisers said.
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India’s health ministry has asked the nation’s drug regulator to review U.S. court documents that alleged Ranbaxy Laboratories Ltd. sold adulterated drugs, according to a ministry official familiar with the matter.
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Results from Given Imaging Ltd.’s latest clinical study of a pill-sized camera used to identify colon cancer probably will help the Israeli manufacturer secure U.S. regulatory approval this year, Chief Executive Officer Homi Shamir said.
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Medtronic Inc.’s CoreValve, a device threaded into the heart via a catheter and expanded to repair a damaged aortic valve, dramatically improved symptoms without causing excessive cardiovascular complications after one year.
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Sales of rice from China’s top producing province have slumped amid reports that supplies from Hunan contain traces of cadmium that exceed government limits, a state-owned agriculture researcher said.
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Intuitive Surgical Inc. acted like a “car dealership” in training doctors to use its robotic surgery system and should pay more than $8 million in damages to the estate of a man who lost his life because of the company’s practices, a lawyer for the estate said.
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A cheap regimen of vitamins in use for decades is seen by scientists as a way to delay the start of Alzheimer’s disease and dementia, a goal that prescription drugs have failed to achieve.
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Merck & Co.’s experimental insomnia drug, designed to turn off wakefulness rather than subdue the brain into slumber like Ambien, may only be safe at lower doses than what the company has proposed, U.S. regulators said.
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H. Lundbeck A/S, Denmark’s second- largest drugmaker, said its experimental antidepressant Brintellix improved symptoms better in a higher dose in a late- stage U.S. study, as the medicine awaits regulatory approval.
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Johnson & Johnson, the world’s biggest maker of health-care products, said it will stop selling metal-on-metal and ceramic-on-metal hip replacements as demand wanes for the devices and U.S. regulators seek new rules.
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