GO
Loading...

FDA

More

  • Pfizer Wheelin' and Dealin' For Encysive's Thelin Wednesday, 20 Feb 2008 | 10:54 AM ET

    The world's biggest drug company is spending chump change to take out a little biotech at a 118 percent premium. Pfizer, which has a cash hoard of more than $20 billion, is plunking down a paltry (for Pfizer, that is) $195 million in cash money to buy Encysive Pharmaceuticals.

  • Genentech, JNJ, Pfizer: Big Days Ahead For Pharma Friday, 15 Feb 2008 | 9:41 AM ET

    Taking an extra day off to extend the long weekend before we go into a very busy period. Possibly a week from today (Friday) Genentech could get word from the Food and Drug Administration on its cancer drug Avastin for breast cancer. The agency could approve it, reject it or delay making a decision.

  • Genentech's Avastin Study: Will It Help Get FDA Approval? Wednesday, 13 Feb 2008 | 10:29 AM ET

    After the closing bell yesterday Genentech popped out a stock-moving press release. The world's most highly-valued biotech announced that its drug Avastin when used in combo with Sanofi-Aventis' chemo drug, Taxotere, helped women with a certain type of aggressive, advanced breast cancer live longer without the disease getting worse.

  • The current issue (February 18, 2008) of New York Magazine has a story that it teases on the cover above the masthead, "No Smoking Wonder Drug." Below it in drug-label fine print the sub-head is: "Makes quitter talk to potted plants."

  • Dendreon/Provenge Petition: It Ain't Me On There Monday, 11 Feb 2008 | 12:39 PM ET

    Anyone who has followed the Dendreon/Provenge saga knows there are a lot of passionate people attached to it. And apparently one of them may go by the name Mike Huckman. Last night it was brought to my attention that my name appears (or appeared) on line 277 of this online petition.

  • Allergan, Medicis Shares Drop on Botox Probe Friday, 8 Feb 2008 | 12:27 PM ET

    Regulators said they're reviewing the safety of Allergan's Botox and a competing product after reports of deaths and serious reactions in some patients.

  • FDA At Level "Orange" Safety Warning? Monday, 4 Feb 2008 | 2:14 PM ET

    The Food and Drug Administration continues to get a lot of attention and scrutiny. In an editorial over the weekend "The New York Times" wrote, "The F.D.A. desperately needs an infusion of money and talent." Then, "USA Today" today is running a front-page article on something I recently blogged about and other reporters tackled a few weeks ago regarding the agency approving so few drugs last year.

  • 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.