Posts Tagged ‘drug’


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  • What Does the FDA’s Avastin Decision Mean for Breast Cancer Patients?

    Saturday, November 19th, 2011 at 05:13 | Comments Off

    The Food and Drug Administration’s decision to revoke approval of Roche’s Avastin for advanced breast cancer is likely to curtail use of the $6 billion-a-year drug for such patients. But it’s not likely to put an end to prescribing.

    Today’s action doesn’t affect the drug’s other approved uses, which include certain types of colon, lung, kidney and brain cancers, the FDA said. And physicians are free to prescribe an approved drug for any use they see fit.

    One question, ..read more

  • A.M. Vitals: Human Stem Cells Ease Parkinson’s Symptoms in Rodents

    Tuesday, November 8th, 2011 at 00:37 | Comments Off

    Human Cells, Rodent Brains: Research published in Nature describes how scientists treated Parkinson’s disease in mice and rats by converting human embryonic stem cells into nerve cells that released the neurotransmitter dopamine, then transplanting the cells into the rodents’ brains, the WSJ reports. Further animal studies are necessary before the technique could be tested in humans, the paper says.

    MRSA and the Flu: Research published in Pediatrics finds infection by MRSA increased the chances that a previously healthy ..read more

  • Does a Company Have a Soul?

    Wednesday, October 19th, 2011 at 09:50 | Comments Off

    In an interview with WSJ’s Dennis Berman, GlaxoSmithKline CEO Andrew Witty discusses why the drug maker is forgoing profits from the malaria vaccine it’s developing for children in Africa-and why he believes his company has a soul.

    Here is the original:  Does a Company Have a Soul?/a>

  • A.M. Vitals: Mela Sciences’ Melanoma Diagnostic On Track For Approval

    Monday, September 26th, 2011 at 22:26 | Comments Off

    A Path to Approval: Reversing an earlier decision, the FDA has cleared a path to approval for a medical device made by Mela Sciences that aims to help doctors more accurately diagnose melanoma, the WSJ reports. MelaFind is “approvable” pending some final negotiations, the FDA told the company last week; previously the agency had called on the company to conduct a large new study. The device is already approved for use in 27 European countries, the paper ..read more

  • How Vulnerable Are Pharma Stocks to Fiscal Austerity?

    Tuesday, August 9th, 2011 at 06:37 | Comments Off

    At first blush, Washington’s tough talk about fiscal austerity doesn’t look good for drug makers. Government programs including Medicare and Medicaid spend $99 billion each year on prescription medicines, according to Washington consulting firm Avalere Health, making for a ripe cost-cutting target.

    Not surprisingly, drug stocks have dropped with the rest of the market recently. As the WSJ reports, pharma companies have ramped up their lobbying, warning that cuts to the drug prices paid by Medicare’s drug benefit, for example, could ..read more

  • Hospital Blood Tests Tied to Anemia in Heart-Attack Patients

    Tuesday, August 9th, 2011 at 06:21 | Comments Off

    Ask anyone who’s spent time in the hospital — patients get a lot of blood taken over the course of their stay.

    A blood test can provide crucial information that can’t be gotten any other way. But sometimes there may be a downside. A study of heart-attack patients just published online by the Archives of Internal Medicine finds that blood loss from diagnostic tests is associated with acquiring anemia in the hospital. And anemia — a decrease in the red blood ..read more

  • Reader Consult: Would the FDA Swallow an OTC Lipitor?

    Thursday, August 4th, 2011 at 07:06 | Comments Off

    Pfizer is hoping to milk even more dollars from its blockbuster Lipitor by introducing an over-the-counter version of the cholesterol-lowering drug, the WSJ reports, citing people familiar with the matter.

    Whether Pfizer can get the FDA to swallow an OTC statin is another matter entirely. The WSJ reports the company would first need to conduct research demonstrating consumers could follow instructions and properly take an OTC iteration of Lipitor. (That wouldn’t happen before patent protection for the prescription drug expires in ..read more

  • A.M. Vitals: Surgically Implanting Explosives Wouldn’t Be That Hard

    Thursday, July 7th, 2011 at 22:54 | Comments Off

    Surgical Threat?: U.S. officials are warning that terrorists are considering surgically implanting explosive devices in would-be suicide bombers, who then might board planes; surgeons tell the WSJ the medical procedure itself wouldn’t be that difficult. Breast, pectoral or buttock implants could be filled with liquid explosives and explosive implants could be placed in the chest cavity or elsewhere, experts tell the paper.

    Plea Deal: Canadian physician Anthony Galea pleaded guilty to charges that he brought human growth hormone ..read more

  • Getting More Drugs Approved for Rare Diseases

    Wednesday, July 6th, 2011 at 22:29 | Comments Off

    A new paper offers a possible road map for getting more drugs approved to treat rare diseases. One key recommendation: improving access to the FDA’s accelerated approval pathway, originally developed to quickly get treatments to patients with life-threatening diseases.

    The paper, written by Brigitta Miyamoto and Emil Kakkis of the Kakkis EveryLife Foundation and published today in the Orphanet Journal of Rare Diseases, says the FDA should offer specific guidelines on how companies seeking to develop drugs for rare diseases can ..read more

  • A.M. Vitals: Medicare Will Pay for Dendreon’s Provenge

    Friday, July 1st, 2011 at 22:49 | Comments Off

    Coverage Decisions: Medicare will cover Dendreon’s Provenge for certain forms of advanced prostate cancer, calling the $93,000 treatment “reasonable and necessary,” the WSJ reports. (Here’s the decision memo.) Medicare will also continue to cover Roche’s Avastin for breast-cancer patients, even if the FDA follows the advice of its outside advisory committee and revokes approval for that use, the New York Times reports.

    Anti-Obesity Laws Challenged: Local laws requiring restaurants to eliminate trans fats, label menus with calorie counts ..read more