Fri, Oct 31st, 2008 | Archive |

WASHINGTON – The government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage, a consumer group said Thursday.The consumer group, Public Citizen, filed a petition with the Food and Drug ...Read More

US FDA issues alert on kidney problems with Byetta

Mon, Nov 2nd, 2009 | Health |

* Label changes for Lilly-Amylin diabetes drug * FDA says reports represent small percentage of patients NEW YORK, Nov 2 (Reuters) - Patients and doctors should beaware of possible kidney function problems with Eli Lilly(LLY.N) and Amylin Pharmaceuticals' (AMLN.O) Byetta diabetesdrug, U.S. ...Read More

Lupus drug completes testing, heads to FDA for approval

Mon, Nov 2nd, 2009 | Health |

Rockville-based Human Genome Sciences Inc. announced on Monday that its experimental Lupus drug has completed its final round of testing at a higher dose and will now be headed to the Food and Drug Administration for approval. The latest round of ...Read More

Merck: FDA won't accept its application for combo cholesterol pill including Pfizer's Lipitor

Mon, Nov 2nd, 2009 | Business |

TRENTON, N.J. (AP) - U.S. regulators have refused to accept drugmaker Merck & Co.'s application for a new, combination cholesterol pill that includes rival Pfizer's Lipitor, the world's top-selling drug. Merck disclosed the rare move by the Food and Drug Administration ...Read More

FDA won't accept Merck's application for new drug

Mon, Nov 2nd, 2009 | Business |

WHITEHOUSE STATION, N.J. -- U.S. regulators won't accept drugmaker Merck's application for a new combination cholesterol pill that includes rival Pfizer's Lipitor, the world's top-selling drug. Merck & Co. disclosed the rare move by the Food and Drug Administration in a regulatory ...Read More

GTx Shares Fall On Lack Of Approval For Bone Drug

Mon, Nov 2nd, 2009 | Health |

NEW YORK (Dow Jones)--GTx Inc. (GTXI) shares plummeted to an all-time low Monday after the U.S. Food and Drug Administration didn't approve the company's bone drug and said it wants to see an additional late-stage study on the treatment. The FDA ...Read More

Promise of a New Lupus Treatment is a Groundbreaking Achievement

Mon, Nov 2nd, 2009 | Health |

BENLYSTA Successful in Second Pivotal Clinical TrialWASHINGTON--(Business Wire)--Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) today announced positiveresults from BLISS-76, the second of two large-scale phase III clinical trialsof BENLYSTA (belimumab) for treating systemic lupus. A full presentation ofresults from BLISS-52 ...Read More

Smokers of flavored cigarettes change habit

Mon, Nov 2nd, 2009 | Health |

Smokers of flavored cigarettes change habit Royal Oak -- Jaclyn Glover smokes clove cigarettes because they smell better, taste better and make her car smell like flowers. With a federal ban on the sweet-smelling cigarettes taking effect this fall, she went to tobacco stores and stocked ...Read More

Stroke risk linked to anemia drug, study finds

Fri, Oct 30th, 2009 | Top Stories |

A new study raises fresh safety concerns about widely used anemia medicines, finding that the drug Aranesp nearly doubled the risk of stroke in people with diabetes and chronic kidney problems who are not yet sick enough to need dialysis. The ...Read More

GAO: FDA fails to follow up on unproven drugs

Mon, Oct 26th, 2009 | Top Stories |

WASHINGTON -The Food and Drug Administration has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn't extend patients' lives, say congressional investigators. A report due out Monday from the Government Accountability ...Read More

"Smart Choices" Food Labeling Program Halts Over FDA Concern

Sat, Oct 24th, 2009 | Business |

(AP) PORTLAND, Ore. - A food industry group is voluntarily halting promotion of its nutrition labeling program after federal regulators said such systems could mislead consumers, officials with the group said Friday. Industry leaders launched the "Smart Choices" program in August ...Read More

Smart Choices food labels are put on hold - Omaha World

Sat, Oct 24th, 2009 | Business |

Smart Choices food labels are put on hold - Omaha World PORTLAND, Ore. (AP) - The Smart Choices nutrition labeling program, created voluntarily by nine large U.S. manufacturers, is halting after federal regulators said such systems could mislead consumers, officials with the labeling group said Friday. Industry leaders launched the program this ...Read More

Food industry stops promoting "Smart Choices" after FDA says it will tackle misleading labels

Fri, Oct 23rd, 2009 | Business |

Food industry stops promoting PORTLAND, Ore. (AP) - A food industry group is voluntarily halting promotion of its nutrition labeling program after federal regulators said such systems may be misleading consumers, officials with the group said Friday. Industry leaders launched the "Smart Choices" program in ...Read More

FDA Halts Food Label Program; Could Mislead Consumers

Fri, Oct 23rd, 2009 | Top Stories |

FDA Halts Food Label Program; Could Mislead Consumers The Smart Choices nutrition labeling program, created voluntarily by nine large U.S. manufacturers, is halting after federal regulators said such systems could mislead consumers, officials with the labeling group said Friday. Industry leaders launched the program this year to highlight foods ...Read More

'Smart Choices' Food-Labeling Program Is Halted

Fri, Oct 23rd, 2009 | Business |

'Smart Choices' Food-Labeling Program Is Halted PORTLAND, Ore. -- The Smart Choices nutrition labeling program, created voluntarily by nine large U.S. manufacturers, is being halted after federal regulators said such systems could mislead consumers, officials with the labeling group said Friday. Industry leaders launched the program this ...Read More

'Smart Choices' food labeling program halted over FDA concern

Fri, Oct 23rd, 2009 | Top Stories |

PORTLAND, Ore. ? A food labeling program created by U.S. manufacturers is being voluntarily halted after federal regulators said it could be misleading to consumers. Companies such as Kraft, Kellogg and General Mills worked together to launch the "Smart Choices" program ...Read More

Senate food bill good first step, needs work: FDA

Thu, Oct 22nd, 2009 | Most Viewed |

WASHINGTON (Reuters) - A Senate bill that would expand U.S. Food and Drug Administration oversight and give it the power to recall food is a step forward but needs to be stronger, the head of the agency told lawmakers on ...Read More

Amgen 3Q Profit Up 24%; FDA Seeks Bone Drug Info

Wed, Oct 21st, 2009 | Business |

(Updates with company and analyst comments, other details) NEW YORK (Dow Jones)--Amgen Inc. (AMGN) reported a 24% rise in third-quarter profit - easily beating expectations - driven by cost cuts and lower taxes amid strong sales of most major products. The strong ...Read More

Amgen 3Q Profit Up 24%; FDA Seeks Info On Bone Drug

Wed, Oct 21st, 2009 | Business |

NEW YORK (Dow Jones)--Amgen Inc. (AMGN) reported a 24% rise in third-quarter profits, easily beating expectations, driven by cost cuts and strong sales on most major products. The strong earnings prompted the Thousand Oaks, Calif., drug maker to again raise its ...Read More

Amgen Profit Jumps 23% on Higher Margins

Wed, Oct 21st, 2009 | Business |

Amgen Inc. reported its earnings jumped 24% on higher margins, as third-quarter results beat analysts' expectations. The drug maker again boosted its full-year earnings outlook, this time by 10 cents to between $4.90 and $5.05 a share. The Thousand Oaks, Calif., ...Read More

Amgen 3Q Profit Jumps 24%, Boosts FY Outlook; FDA Seeks Info

Wed, Oct 21st, 2009 | Business |

Amgen Inc.'s (AMGN) third-quarter earnings jumped 24% on higher margins as results beat analysts' expectations. The drug maker again boosted its full-year earnings outlook, this time by a dime to $4.90 to $5.05 a share. It affirmed revenue will likely be ...Read More