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  • Pfizer's Chantix Suffers Yet Another Blow From FDA Friday, 1 Feb 2008 | 4:53 PM ET

    Pfizer tried to get out in front of the psychiatric side-effect issues on its stop-smoking drug by adding information about behavioral changes, mood swings, thoughts of suicide, etc. to the label last month.

  • FDA to Pfizer: Toughen Warning on Chantix Friday, 1 Feb 2008 | 3:44 PM ET

    U.S. regulators on Friday said Pfizer's anti-smoking drug Chantix appears increasingly likely to be linked to serious psychiatric behavior, and called for stronger label warnings.

  • Avandia Study Results Were Leaked Early to Glaxo Wednesday, 30 Jan 2008 | 12:46 PM ET
    The company logo of GlaxoSmithKline, is seen on the headquarters building in London, Wednesday May 10, 2006. GlaxoSmithKline PLC said Wednesday it has been granted a High Court injunction against animal rights activists who sent threats to the drugmaker's shareholders, barring them from sending more letters or revealing private information about the investors. (AP Photo/Alastair Grant)

    The scientific journal Nature reported today that a peer-reviewer for The New England Journal of Medicine leaked key study results on GlaxoSmithKline's diabetes drug Avandia to the company weeks before they were published.

  • Bush Pushes Congress on Stimulus Package Friday, 25 Jan 2008 | 5:19 PM ET

    President Bush urged Congress on Friday to quickly pass an economic stimulus package void of extraneous spending, saying only quick action will kickstart the sputtering economy. "I strongly believe it would be a mistake to delay or derail this bill," Bush said.

  • Dendreon's Provenge: No Congressional Decision-YET Friday, 18 Jan 2008 | 4:04 PM ET

    I blogged recently that a spokesperson for the House Energy and Commerce Committee had told me a decision could be made by the end of this week regarding the Dendreon saga.

  • Pfizer's Chantix Is "Smokin'" Again Tuesday, 15 Jan 2008 | 10:52 AM ET

    I had planned to blog about the nearly unanimous bearish analyst commentary this morning after Genentech's earnings report yesterday. The biotech giant beat on earnings per share, but came up short on Street expectations for sales of its top four drugs. DNA shares are under pressure again today.

  • Dendreon's Saga Over Provenge "Edited Up" A Notch Friday, 11 Jan 2008 | 1:09 PM ET

    The brouhaha over the Food and Drug Administration's delay of the potential approval of the prostate cancer drug Provenge from the small biotechnology company Dendreon is now entering the prestigious and credible sphere of peer-reviewed scientific journals.

  • New York Launches Intel Antitrust Probe Thursday, 10 Jan 2008 | 1:32 PM ET

    The office of New York Attorney General Andrew Cuomo on Thursday said it launched a formal investigation into Intel to determine whether the world's biggest chipmaker violated state and U.S. antitrust laws to squeeze out its rival, Applied Micro Devices.

  • Murder Accusation Made in Tobias Estate Case Monday, 7 Jan 2008 | 9:46 AM ET

    Attorneys for the brothers of hedge fund manager Seth Tobias say his wife killed him because "Seth was worth substantially more to (her) dead than he was alive, and she knew that."

  • FDA Set to OK Cloned Meat: WSJ Friday, 4 Jan 2008 | 3:36 AM ET

    The Food and Drug Administration is expected to declare as early as next week that meat and milk from cloned animals and their offspring are safe to consume, the Wall Street Journal reported without naming its source.

  • Amgen: Anemia Drugs Take Yet Another Hit Thursday, 3 Jan 2008 | 4:18 PM ET

    The Food and Drug Administration late this morning put out a news release with the heading, "FDA Receives New data on Risks of Anemia Drugs." This is more bad news for an additional population of cancer patients and, of course, Amgen and, to a lesser extent, Johnson and Johnson.

  • FDA Panel Rejects Genentech Drug for Breast Cancer Thursday, 6 Dec 2007 | 3:35 AM ET

    A panel of government advisers said that Genentech drug Avastin should not be approved for expanded use in breast-cancer patients, sending the company's shares sharply lower.

  • FDA Panel Rejects Genentech Drug for Breast Cancer Wednesday, 5 Dec 2007 | 3:43 PM ET

    A panel of government advisers said that Genentech drug Avastin should not be approved for expanded use in breast-cancer patients, sending the company's shares sharply lower.

  • Genentech Drug Toxicity Under FDA's Microscope Monday, 3 Dec 2007 | 11:37 AM ET
    Genetech

    The benefits of Genentech's cancer drug Avastin in breast cancer should be weighed against some toxic side effects, including the potential for death, U.S. regulatory staffers said in documents released Monday.

  • Genentech, Amgen And The Fight Against Breast Cancer Monday, 3 Dec 2007 | 10:53 AM ET

    Although the stock movement this morning is not reflecting it, the latest developments in Amgen and Genentech's efforts to come up with new treatments for breast cancer are emblematic of the opposite direction these California-based biotech behemoths and rivals are headed.

  • US Panel Backs Abbott's Drug-Coated Heart Stent Thursday, 29 Nov 2007 | 9:18 PM ET

    Abbott Laboratories moved closer to joining the U.S. market for drug-coated heart stents on Thursday as an advisory panel backed the company's experimental device.

  • Late yesterday, a bullet crossed the Dow Jones newswire saying, "FDA Warns GlaxoSmithKline on Breast-Cancer Drug Promotion." Almost immediately, my producer and I got a call from the CNBC staffer who was manning what we call our "Alerts Desk" asking us if we'd seen the news and if we could provide any context.

  • St. Jude Medical Wins FDA Approval for Heart Valve Monday, 26 Nov 2007 | 9:49 AM ET

    St. Jude Medical on Monday said U.S. regulators approved the sale of a new heart valve with technology designed to protect against hardening of the tissue due to calcification.

  • Pfizer's Smoking Problem Helps "Suffocate" Stock Price Wednesday, 21 Nov 2007 | 11:27 AM ET

    Late yesterday afternoon, the Food and Drug Administration put out what it calls an "Early Communication" announcing that it's looking into possible dangerous side effects from Pfizer's hot, new smoking cessation pill, Chantix. The company sold nearly a quarter-billion dollars worth of the drug in the third quarter which put it on track to quickly achieve billion-dollar blockbuster status.

  • AstraZeneca Gets New US Approval for Seroquel XR Friday, 16 Nov 2007 | 8:58 AM ET

    AstraZeneca said on Friday that U.S. health regulators had approved Seroquel XR, an extended-release version of one of its top-selling drugs, as a maintenance treatment for adult schizophrenia patients.