Posts Tagged ‘Fda’


    Loading...

  • FDA Warns on Statin Drugs

    Wednesday, February 29th, 2012 at 08:49 | Comments Off

    The FDA raised safety concerns about the popular class of cholesterol-fighting drugs. The drugs have been taken for years by tens of millions of people and include brand names such as Lipitor and Crestor. Ron Winslow reports on the News Hub. Photo: Getty Images.

    Here is the original post: FDA Warns on Statin Drugs/a>

  • A.M. Vitals: FDA Warns of Fake Avastin in U.S.

    Thursday, February 16th, 2012 at 01:02 | Comments Off

    Fake Avastin in the U.S.: A counterfeit version of Roche’s Avastin anti-cancer drug has been found in the U.S., though it’s not known how much was distributed, whether patients received it or whether it caused harm, the WSJ reports. The FDA has notified 19 medical practices in the U.S. that it says might have purchased the fake Avastin, which doesn’t contain the active ingredient in the real drug. A spokeswoman for Roche unit Genentech says the counterfeit ..read more

  • FDA Approves Vertex’s Kalydeco, But It Won’t Come Cheap

    Wednesday, February 1st, 2012 at 07:41 | Comments Off
    A young patient holds Kalydeco, a cystic-fibrosis treatment from Vertex just approved by the FDA.

    Certain cystic-fibrosis patients will now have an FDA-approved treatment that targets an underlying cause of their disease.

    But that drug — Kalydeco, from Vertex Pharmaceuticals — won’t come cheap.

    As Dow Jones Newswires reports, the annual cost will be $294,000. Vertex has set up a patient-assistance program to help patients pay for the treatment.

    Kalydeco was approved to treat the estimated 4% of cystic-fibrosis patients who have a mutation ..read more

  • FDA (Finally) Gives Amylin’s Bydureon a Thumbs-Up

    Saturday, January 28th, 2012 at 09:19 | Comments Off

    Bydureon, the once-weekly injection for treating patients with type 2 diabetes, has finally won the FDA’s okay.

    As Dow Jones Newswires reports, it’s been a long, bumpy road to approval for the drug’s developer, Amylin Pharmaceuticals.

    (Alkermes is behind the extended-release technology used to deliver the drug, a longer-acting version of Amylin’s twice-daily Byetta.)

    Amylin started working on the drug in 1999 and first applied for FDA approval — with its then-partner Lilly — a decade later. But the agency in 2010 said ..read more

  • What Are the Obstacles to Digital Health Records?

    Saturday, January 28th, 2012 at 08:35 | Comments Off

    What’s standing in the way of the wider spread of health IT?

    Plenty of things, according to a new report from the Bipartisan Policy Center. The report says boosting use of electronic medical records and other health IT “enjoys bipartisan support.” It’s also being pushed by billions of dollars in government incentives.

    The assumption is that health IT can help improve health outcomes, improve the experience of care and save money. But there are gaps and barriers to its effective use, the ..read more

  • A.M. Vitals: FDA Wants More Data on Diabetes Drug from Bristol-Myers, AstraZeneca

    Friday, January 20th, 2012 at 00:39 | Comments Off

    Seeking More Data: The FDA wants more information about an experimental diabetes drug from Bristol-Myers Squibb and AstraZeneca before considering it for approval, Dow Jones Newswires reports. The companies said the agency wants more clinical data in order to better assess the risks and benefits of dapagliflozin, which is a new type of therapy for diabetes, and that they remain committed to the drug. An FDA advisory panel voted against approving the drug in July, raising safety ..read more

  • GAO Report Blames Drug Shortages On Manufacturing Problems

    Thursday, December 15th, 2011 at 15:59 | Comments Off

    Central to the drug-shortage issue is a chicken-and-egg question that often leaves legislators scratching their heads at congressional hearings.

    Chicken: Are the shortages of crucial drugs caused by factory flaws and shutdowns? Or egg: Are shortages somehow caused by economics, like the thin profit margins of generic drugs?

    A federal report to be released Thursday comes down with both feet in the chicken camp.

    “Manufacturing problems were the primary cause of most shortages,” says an analysis by the Government Accountability Office. And how ..read more

  • Reader Consult: Was Sebelius Right to Block Broader Plan B Availability?

    Thursday, December 8th, 2011 at 10:12 | Comments Off

    The good news for Teva: the FDA agreed with the pharma company that Plan B One-Step, a pill intended to prevent potential implantation of a fertilized egg, should be sold over the counter and without a prescription to teens younger than 17.

    The bad news for Teva, as the WSJ reports: HHS head Kathleen Sebelius didn’t agree, and overruled the agency’s recommendation. So Plan B will continue to be sold from behind pharmacy counters, and those under 17 will need a ..read more

  • A.M. Vitals: Breast Cancer Research Covers Radiation Treatment

    Thursday, December 8th, 2011 at 00:45 | Comments Off

    Breast-Cancer Developments: Research presented at the San Antonio Breast Cancer Symposium found that a genetic test called Oncotype DX can help pinpoint the patients with ductal carcinoma in situ, a very early form of breast cancer, who stand to benefit from post-surgical radiation treatment, the WSJ reports. Meantime, a separate study found that partial radiation therapy known as brachytherapy may be associated with an increased risk of a subsequent mastectomy compared to women who had standard radiation ..read more

  • 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