Government Agencies FDA

  • 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 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.

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    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

    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.

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    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.

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    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.

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

  • 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

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

  • 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.

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    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.

  • 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.

  • 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, 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.


    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.

  • 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...

  • Eli Lilly's drug Zyprexa.

    U.S. regulators have rejected a long-acting injectable form of Eli Lilly and Co's blockbuster schizophrenia drug Zyprexa, the company said Thursday, sending its shares down almost 2 percent.

  • Analysts raised forecasts for Roche Holding on Monday after U.S. regulators approved its Avastin drug for treating advanced breast cancer, adding a potentially significant new revenue source.

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    I always prefer it when pharmaceutical/biotech execs and analysts can break out of their scientific/financial jargon and give good soundbites or quotes. So, among the flurry of research notes I've received over the weekend and this morning on the Genentech Avastin news the award goes to Rodman & Renshaw's Mike King who writes, "The biotech leader has its groove back."

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    Shortly before the closing bell trading in shares of Genentech was halted for news pending. Then, right after the bell the company issued this press release announcing the Food and Drug Administration has granted "accelerated approval" to Genentech's Avastin for use on breast cancer.