Posts Tagged ‘bloomberg-news’


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  • Countdown to Generic Lipitor: More Answers to Your Questions

    Wednesday, November 30th, 2011 at 07:33 | Comments Off

    Lipitor goes generic tomorrow, and we know you have a lot of questions about how that will affect your prescription.

    The WSJ answers some of them in a story today. (And we answered a couple yesterday.)

    Many readers wanted to know whether they’d get the name-brand or the generic version (atorvastatin calcium) when next they filled a prescription. The short answer: you won’t know until you get to the pharmacy.

    The timeline for switching to the generic varies by health plan, the WSJ ..read more

  • A.M. Vitals: Microbicide Gel Trial in Africa Canceled

    Tuesday, November 29th, 2011 at 00:38 | Comments Off

    Trial Disappointment: A trial conducted in Africa of a microbicide gel containing the anti-HIV drug tenofovir has ended because the gel didn’t protect women from contracting the virus, the New York Times reports. Part of the study — which also looked at whether two different pills protected against the virus — is continuing and data have not yet been released, making it difficult to figure out why, exactly, the gel didn’t appear to work, the paper says.

    New ..read more

  • A.M. Vitals: Merck’s 2nd-Quarter Profit Rises; Announces More Layoffs

    Friday, July 29th, 2011 at 22:38 | Comments Off

    It’s Merck’s Turn: Merck reported a second-quarter profit increase in line with analysts’ expectations, affirmed its revenue guidance for the full year and said it would cut as many as 13,000 additional jobs by the end of 2015, Dow Jones Newswires reports. Profit rose to $2.02 billion, or 65 cents a share, up from $752.4 million, or 24 cents a share, a year earlier, helped by a $1.34 billion tax benefit. Excluding restructuring and other charges, earnings ..read more

  • A.M. Vitals: FDA Panel Votes Against Diabetes Drug From Bristol, Astra

    Wednesday, July 20th, 2011 at 22:25 | Comments Off

    Drug Vote: An FDA advisory panel voted 9-6 against approving dapagliflozin, a new type of diabetes drug from Bristol-Myers Squibb and AstraZeneca, saying more information is needed on possible risks including breast and bladder cancers, the WSJ reports. Some panel members, however, said teasing out those possible safety problems would be best accomplished not by requiring more studies before approval, but by using post-marketing studies and patient registries. The FDA often, but not always, follows the advice of its outside ..read more

  • A.M. Vitals: FDA Panel Recommends Pulling Avastin’s Breast-Cancer Approval

    Thursday, June 30th, 2011 at 22:42 | Comments Off

    Avastin Vote: An FDA appeals panel made up of outside experts voted 6-0 to recommend the agency remove Avastin’s approval for breast cancer, the WSJ reports. Panel members said studies showed the Roche drug provided no meaningful benefit to patients while raising the risk for serious side effects. The ultimate decision on the drug’s breast-cancer indication rests with FDA head Margaret Hamburg. Regardless of what she decides, the drug will remain on the market since it’s approved ..read more

  • A.M. Vitals: FDA Appeals Panel to Hold Avastin Hearing This Week

    Monday, June 27th, 2011 at 22:34 | Comments Off

    Avastin Arguments: At an FDA appeals hearing tomorrow and Wednesday, Roche’s Genentech unit will argue that the conditional approval for its drug Avastin to be used against breast cancer shouldn’t be pulled, despite evidence showing it doesn’t help patients live any longer and carries the risk of serious side effects, the WSJ reports. FDA head Margaret Hamburg will ultimately make the decision about the drug, which is already approved for use in other cancers.

    Sprouts, Again: The deadly ..read more

  • A.M. Vitals: FDA Advisory Panel Votes Against Novartis’s Gout Drug

    Wednesday, June 22nd, 2011 at 23:04 | Comments Off

    Drug Vote: An FDA advisory panel voted not to recommend approval of Novartis’s Ilaris for gout pain, though it did say the drug is effective, the WSJ reports. Safety concerns, specifically the risk of serious infections, gave committee members pause, but several said it might be possible for the drug to be approved with restrictions, the paper says. The FDA often but not always follows the advice of its outside panels.

    Diabetes Risk?: A JAMA study of previously ..read more

  • A.M. Vitals: Pfizer’s Chantix May Increase Risk For Heart Patients

    Friday, June 17th, 2011 at 22:51 | Comments Off

    Heart Risk?: The FDA says that people who already have cardiovascular disease may see their chances of a heart attack rise if they take Pfizer’s Chantix smoking-cessation drug, the WSJ reports. The agency based its warning on a trial of 700 heart-disease patients, and says it will update the product’s label and medication guide. Pfizer notes there are big heart benefits to be gained by quitting smoking.

    No Change: The Centers for Medicare and Medicaid Services will leave ..read more

  • Germany Says Sprouts Were Source of E. coli Outbreak, After All

    Friday, June 10th, 2011 at 23:48 | Comments Off

    First it was imported cucumbers, tomatoes and lettuce, then sprouts, then something-but-we-don’t-know-what.

    But according to German authorities, vegetable sprouts grown at a farm in the Lower Saxony region of the country are indeed the source of the E. coli outbreak that has killed 30 people, the WSJ reports. Lettuce, cucumbers and tomatoes have been exonerated.

    Nearly 3,000 people have become ill, some seriously so, and investigators traced the source to the farm. The sprouts never tested positive for the precise type of ..read more

  • Orexigen Says FDA’s Requests for Contrave Trial Aren’t ‘Necessary or Feasible’

    Saturday, June 4th, 2011 at 03:34 | Comments Off

    What does it take to get an obesity drug approved by the FDA?

    In the case of Orexigen’s Contrave, a lot. Namely, a trial of between 60,000 and 100,000 patients showing that the drug — rejected by the FDA in February — doesn’t raise the risk of heart attack or stroke, the company says.

    As Dow Jones Newswires reports, Orexigen has suspended its U.S. development of Contrave, saying that a trial of that scale is neither feasible nor necessary.

    The company had proposed ..read more