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

FDA clears Glaxo's long-delayed vaccine Cervarix, creating new competition for Merck

Fri, Oct 16th, 2009 | Top Stories |

WASHINGTON (AP) - British drugmaker GlaxoSmithKline said Friday U.S. regulators approved its vaccine Cervarix to prevent the leading cause of cervical cancer in women. The approval from the Food and Drug Administration allows Glaxo to compete against Merck's blockbuster vaccine Gardasil, ...Read More

UPDATE: FDA: Procter & Gamble Warning Posted In Error

Thu, Oct 15th, 2009 | Top Stories |

(Updates with P&G comments and emphasizes which products were implicated). By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The Food and Drug Administration said a warningletter about two Procter & Gamble Co. (PG) Vicks cold products was posted ...Read More

FDA warns P&G over vitamin C in DayQuil and NyQuil

Wed, Oct 14th, 2009 | Top Stories |

CHICAGO, Oct 14 (Reuters) - The U.S. Food and Drug Administration warned Procter & Gamble Co on Wednesday that its Vicks DayQuil and NyQuil products with vitamin C are misbranded and have false and misleading labeling. The FDA's list of approved ...Read More

FDA warns P&G for adding vitamin C to Nyquil

Wed, Oct 14th, 2009 | Top Stories |

Federal drug regulators warned Procter & Gamble on Wednesday for adding Vitamin C to its Vicks cold formulas, a combination not allowed by federal regulations. The Food and Drug Administration said medications like Vicks Nyquil and Dayquil are not permitted to ...Read More

Corcept to raise $18M in sale of stock and options

Tue, Oct 13th, 2009 | Business |

MENLO PARK, Calif.—Corcept Therapeutics Inc. said Tuesday it expects to raise about $18 million by selling stock and options to institutional investors. Corcept said the money will be used to complete enrollment of patients in a late stage clinical trial of ...Read More

Obama's Appointees Are Flexing Their Regulatory Powers

Mon, Oct 12th, 2009 | Politics, Top Stories |

The Obama administration is taking on Cheerios. And popular cold remedies and swimming pool drains and rhinestones on children's clothing. With much of Washington focused on efforts to revamp health care and address climate change, a handful of Obama appointees have ...Read More

Onyx to acquire private biotech for $276 million

Mon, Oct 12th, 2009 | Business |

NEW YORK/PHILADELPHIA (Reuters) - Onyx Pharmaceuticals Inc (ONXX.O) said on Monday it has agreed to buy Proteolix Inc, a privately held biotechnology company developing cancer drugs, for an upfront cash payment of $276 million, sending its shares up more than ...Read More

UBS analyst boosts Amgen price target

Mon, Oct 12th, 2009 | Business |

A UBS analyst on Monday boosted his price target on Amgen Inc., saying the launch of the company's osteoporosis drug denosumab should drive the stock's value. UBS analyst Maged Shenouda reaffirmed a "Buy" rating but now expects shares to reach $70 ...Read More

Onyx Pharma to buy Proteolix and its blood cancer drug candidate; firm to pay $276M upfront

Mon, Oct 12th, 2009 | Top Stories |

NEW YORK (AP) - Onyx Pharmaceuticals Inc. said Monday it will buy cancer drug developer Proteolix Inc. in a deal that could be worth as much as $851 million. Onyx will pay $276 million upfront for the privately held South San ...Read More

FDA Staff Question Clinical Benefit Of Acorda MS Drug

Fri, Oct 9th, 2009 | Business |

(Adds information on MS and how fampridine-SR works in the last paragraph and updated stock price.) WASHINGTON (Dow Jones)--A proposed Acorda Therapeutics (ACOR) drug to treat multiple-sclerosis increased walking speed, but U.S. Food and Drug Administration staff questioned whether the improvement ...Read More

Acorda shares plunge on negative FDA review

Fri, Oct 9th, 2009 | Business, Top Stories |

WASHINGTON—Shares of Acorda Therapeutics plummeted Friday after the Food and Drug Administration issued a negative opinion that questioned the safety and effectiveness of the company's multiple sclerosis drug. A panel of FDA advisers is scheduled to meet next week to vote ...Read More

Acorda's MS Drug May Need More Study, US FDA Says

Fri, Oct 9th, 2009 | Business |

Oct. 9 (Bloomberg) -- Acorda Therapeutics Inc.’s multiplesclerosis drug, the first pill to improve walking ability inpatients with the disabling disease, may not be “clinicallymeaningful,” a U.S. review said. The shares fell 13 percent. Food and Drug Administration reviewers said they ...Read More

US HOT STOCKS: Acorda, Sunrise Senior Living, Spectrum Pharma

Fri, Oct 9th, 2009 | Business |

U.S. stocks rose Friday, with the Dow Jones Industrial Average gaining 21 points to 9808, the Standard & Poor's 500 edging up about 2 points to 1067 and the Nasdaq Composite increasing 8 points to 2132. Among the companies whose ...Read More

US FDA Staff Question Clinical Benefit Of Acorda MS Drug

Fri, Oct 9th, 2009 | Business |

WASHINGTON (Dow Jones)--A proposed Acorda Therapeutics (ACOR) drug to treat multiple sclerosis increased walking speed, but U.S. Food and Drug Administration staff questioned whether the improvement was clinically meaningful. The proposed drug fampridine-SR faces a review by an FDA panel of ...Read More

US FDA staff: limited effect with Acorda MS drug

Fri, Oct 9th, 2009 | Business |

* Drug met main goals of two clinical trials * Secondary review indicated 'very limited effect' * FDA advisers to weigh drug on Wednesday WASHINGTON, Oct 9 (Reuters) - Acorda Therapeutics Inc's(ACOR.O) proposed drug to help multiple sclerosis patients walkbetter appears to have ...Read More

Spectrum says FDA refuses to OK new plea on cancer drug

Fri, Oct 9th, 2009 | Business |

* Says will request meeting with FDA * Says drug non-inferior to current standard drug * Says FDA did not request changes to current indications * Shares fall 17 pct (Recasts, adds details, share movement) Oct 9 (Reuters) - Spectrum Pharmaceuticals (SPPI.O) saidU.S. health ...Read More

FDA Advisory Committee Recommends Approval of Pfizer's Selzentry for Use in Patients Starting...

Thu, Oct 8th, 2009 | Top Stories |

BusinessWire - Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee voted (10 to 4) to recommend the approval of Selzentry(R) (maraviroc) tablets for use in treatment-naive adult patients with CCR5-tropic ...Read More

FDA panel OKs expanded use of HIV drug

Thu, Oct 8th, 2009 | Top Stories |

ADELPHI, Md. - Federal health advisers said Thursday that Pfizer's HIV drug Selzentry should be approved for use by patients who have not already taken other drugs to combat the virus. The Food and Drug Administration's panel of virus experts voted ...Read More

Riskiest Foods: 3 Tips for Protecting Your Family From Illness

Tue, Oct 6th, 2009 | Most Viewed |

Riskiest Foods: 3 Tips for Protecting Your Family From Illness With the release of the Center for Science in the Public Interest's list of the top 10 riskiest foods regulated by the Food and Drug Administration, you may be wondering what's left that is safe to eat and what to ...Read More

Lettuce and eggs top risky food list

Tue, Oct 6th, 2009 | Most Viewed |

NEW YORK (CNNMoney.com) -- Leafy greens -- including lettuce and spinach -- top the list of the 10 riskiest foods, according to a study from a nutrition advocacy group released Tuesday. The Center for Science in the Public Interest listed the ...Read More