GO
Loading...

FDA

More

  • The Great Pfizer Smokeout Thursday, 22 May 2008 | 11:20 AM ET
    Chantix

    It just keeps getting worse. Pfizer, which is staring down the loss of a $13 billion-a-year drug (Lipitor) in the 2010-11 timeframe, needs the rest of its product portfolio and its drug development pipeline to be firing on all cylinders.

  • Bush Won't Veto Bill Halting Shipments to Oil Reserve Thursday, 15 May 2008 | 10:50 AM ET

    The White House said that President Bush would not veto a final bill from Congress that orders a halt to filling the Strategic Petroleum Reserve while oil prices are very high.

  • J&J Stent Ad Under Fire in Medical Journal Wednesday, 14 May 2008 | 5:01 PM ET
    Johnson & Johnson

    Two cardiologists write in "The New England Journal of Medicine" that Johnson and Johnson's first-of-its kind TV commercial for a heart stent is aimed at "millions of people who are ill-equipped to make judgments" about the device.

  • Merck Plans to Reduce US Sales Force by 1,200 Monday, 5 May 2008 | 4:58 PM ET

    Merck, whose earnings have been hurt by patent expirations and declining sales of its Vytorin cholesterol fighter, said Monday it will eliminate another 1,200 members of its U.S. sales force as part of a restructuring begun in late 2005.

  • Merck Warned by FDA over Manufacturing Plant Wednesday, 30 Apr 2008 | 11:51 AM ET

    Merck says it has received a warning letter from the Food and Drug Administration over concerns at one of its major vaccine manufacturing plants.

  • Genentech, Biogen Idec Shares Hit by Study Results Tuesday, 29 Apr 2008 | 12:07 PM ET

    Genentech and Biogen Idec said a key study of Rituxan did not meet its main goal of a response in patients with systemic lupus erythematosus, commonly called lupus.

  • Merck "Adapts" To Tredaptive Setback Tuesday, 29 Apr 2008 | 11:37 AM ET

    Investors are finding no solace in Merck's reaffirmation that it'll still hit its earnings numbers this year. Instead they're punishing the stock after the company announced what everyone is calling a surprise and a significant setback.

  • Merck Shares Plunge as Cholesterol Drug Rejected Tuesday, 29 Apr 2008 | 11:20 AM ET
    Merck

    U.S. health regulators have rejected a new drug from Merck that was designed to raise the level of HDL, or "good" cholesterol, the company said, sending its shares plunging more than 10 percent.

  • US Regulators to Settle with Ex-Fannie Executives Thursday, 17 Apr 2008 | 10:23 PM ET

    U.S. federal regulators will announce a settlement on Friday with former Fannie Mae  executives over their alleged roles in a 2004 multibillion-dollar accounting scandal, a person familiar with the settlement said on Thursday.

  • Antigenics Finds That "Russian Roulette" Pays Off Tuesday, 8 Apr 2008 | 10:31 AM ET

    This morning a little biotech company, Antigenics, announced that Russia has approved its kidney cancer drug Oncophage. It's the first so-called therapeutic cancer vaccine to win full-out approval anywhere in the world.

  • Merck's Singulair Scrutinized for Safety by FDA Thursday, 27 Mar 2008 | 11:35 AM ET

    U.S. regulators on Thursday said they are probing a possible connection between Merck's Singulair asthma drug and suicidal behavior.

  • J&J, Boston Scientific, Medtronic & Abbott: Stent "Stuff" Thursday, 27 Mar 2008 | 10:50 AM ET
    Heart Stent

    Ahead of the world's biggest gathering of cardiologists in Chicago this weekend, there's a flurry of news about stents--the expensive little wire mesh tubes that prop open clogged arteries. First, the Food and Drug Administration has posted new proposed guidelines for pre-and post-market testing of the controversial devices.

  • FDA's Internet Facelift Still A Work In Progress Tuesday, 25 Mar 2008 | 4:47 PM ET
    FDA

    If you haven't seen it yet, check out the new homepage of the Food and Drug Administration web site www.fda.gov. The agency unveiled it the other day. The interior of the web site still looks pretty much the same.

  • Merck And Big Pharma: Both Getting A Stock "Booster" Shot? Wednesday, 19 Mar 2008 | 11:14 AM ET
    Gardasil

    Merck this morning announced that it has filed for Food and Drug Administration approval of its blockbuster cervical cancer vaccine, Gardasil, for women 27-45 years old. Right now it's approved for females 9-26.

  • Amgen And Its Rather Anemic Stock Performance Tuesday, 18 Mar 2008 | 11:54 AM ET

    Shares of Amgen closed just above 43 bucks yesterday. That's more than a five-year low. And they're falling even lower in early trading this morning. Today the company is making its first investor presentation since last week's FDA advisory committee vote to restrict usage of Amgen's anemia drugs on cancer patients.

  • Fidelity anti-money laundering unit probed? Friday, 14 Mar 2008 | 9:56 AM ET

    A federal grand jury and the Securities and Exchange Commission have been investigating the anti-money laundering practices of Fidelity Investments, according to a report in the Boston Business Journal.

  • Amgen, J&J Drug Benefits Upheld by FDA Panel Thursday, 13 Mar 2008 | 4:51 PM ET
    The sign outside Amgen Inc.'s entrance. Thousand Oaks, Calif.

    Scientists advising the Food and Drug Administration said anemia drugs sold by Amgen and Johnson & Johnson should be allowed to stay on the market for chemotherapy patients.

  • Amgen, JNJ Get Somewhat Mixed Message From FDA Panel Thursday, 13 Mar 2008 | 4:32 PM ET

    Amgen, the world's biggest biotech company in terms of sales (Genentech dwarfs Amgen in market cap: $86 billion vs. $51 billion) and Dow component Johnson & Johnson avoided a worst-case scenario this afternoon.

  • Amgen And Genentech: A Big Biotech Double Play Monday, 10 Mar 2008 | 10:50 AM ET
    AMGEN

    This is a big week for the world's top-two biotechnology companies and their investors. Amgen goes before an FDA Advisory Committee Thursday about the side effects of its bread-and-butter franchise Aranesp.

  • FDA Turns Over Dendreon Documents Wednesday, 5 Mar 2008 | 3:49 PM ET

    When I got back from the Pfizer analyst meeting in New York City this afternoon, I found a treasure trove of PDF documents in one of my inboxes from a couple of Dendreon/Provenge proponents from their Freedom of Information Act request to the Food and Drug Administration...