Preparing for the Zombie Apocalypse and the FDA

November 3, 2011 | by

In an effort to promote public health awareness, the U.S. Centers for Disease Control and Prevention (CDC) has outlined preparation basics for the zombie apocalypse [1].

Yes, you read that right: zombie apocalypse.

Zombie apocalypse

As it turns out, preparing for the zombie apocalypse is similar to preparing for any other disaster: stock up on food, water and medications; have tools and supplies on hand; have items for sanitation and hygiene; etc. The CDC outlines emergency preparedness elsewhere on their website, but apparently no one really wants to read about preparing for a tornado, flood or winter weather. What people do want to read about is the zombie apocalypse. Thus, running with the idea that how you prepare is more important that what you prepare for, CDC went with a tongue-in-cheek, partially no-nonsense discussion of the undead and what happens when they attack.

FDA Removing Over-the-counter Asthma Drug From Shelves for Environment

September 30, 2011 | by

Users of Primatene Mist, the only over-the-counter treatment for acute symptoms of asthma, will need to find an alternative as of December 31, 2011. The U.S. Food and Drug Administration (FDA) recently announced that the medication will no longer be available because it uses chlorofluorocarbons (CFCs) as a propellant agent [1], and CFCs have long been known to deplete Earth’s ozone layer.

Primatine Mist spray

Biomarker Bulletin: August 23, 2011

August 23, 2011 | by

Biomarker Bulletin is an occasionally recurring update of news focused on biomarkers aggregated at BiomarkerCommons.org. Biomarkers are physical, functional or biochemical indicators of normal physiological or disease processes. The individualization of disease management — personalized medicine — is dependent on developing biomarkers that promote specific clinical domains, including early detection, risk, diagnosis, prognosis and predicted response to therapy.

Biomarker Commons

  • Biomarker Commons Named World Companion Diagnostics Summit Media Partner

    Diagnostics used to select patients for treatment with a particular therapeutic or determine what and/or how treatment will be administered have been termed companion diagnostics. Companion diagnostics hold great promise for personalized medicine. A companion diagnostic is a biomarker(s) used in a specific context that provides biological and/or clinical information that enables better decision making about the development and use of a potential therapeutic. Given the significance of companion diagnostics, I’m proud to announce Biomarker Commons’ first media partnership with the 4th World Companion Diagnostics Summit.

  • Personalized Medicine or Patient-centered Care?

    Personalized medicine is a term used in science and medicine that holds significant promise of administering medicines specifically tailored to an individual’s genome or metabolism. However, an editorial published yesterday in the Canadian Medical Association Journal (CMAJ) suggests that the term creates an image for the public that is completely opposite of science and technology and sets up unrealistic expectations.

  • FDA, EMA Seek Input on Companion Diagnostics, Genomic Biomarkers

    Regulators in the U.S. and Europe have each posted requests for public comment on issues affecting the development of medicines by drug companies.

  • FDA Issues New Guidelines on Clinical and Nonclinical Genomic Biomarkers

    The U.S. Food and Drug Administration (FDA) has issued new guidelines on biomarkers related to drug or biotechnology product development. The guidance was developed within the Efficacy Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

  • Neuroimaging Identifies an Endophenotype and Candidate Biomarker for Autism

    In response to facial expression of emotional, a similar pattern of brain activity is observed in both people with autism and their unaffected siblings. Researchers from the University of Cambridge recently used functional magnetic resonance imaging (fMRI), a specialized MRI scan used to measure the change in blood flow related to neural activity in the brain, to show that reduced activity in areas of the brain associated with empathy and face processing is a candidate biomarker for familial risk of autism. The findings were published online recently in the journal Translational Psychiatry.

Flu Vaccine for the 2011-2012 Season Approved

July 20, 2011 | by

On Monday, the U.S. Food and Drug Administration (FDA) said it had approved the formulation for the 2011-2012 vaccine [1]. This year’s formulation is designed to protect against all three strains included in last years vaccine. Nevertheless, if you received a flu shot last year, you should still get vaccinated again this year: immunity to influenza viruses from vaccination declines over time and may be too low to provide protection after a year.

Flu vaccine

Amid Product Recalls, J&J Looks to Restore Brand Confidence

May 11, 2011 | by

It’s spring, pollen is everywhere, and for many people, it’s allergy season. However, there’s one thing that’s missing this year: the over-the-counter (OTC) allergy medicine Benadryl. It’s just another of the many products recalled by Johnson & Johnson over the past year-and-a-half. The list of over 40 pulled products is a who’s who of common OTC medications: Tylenol, Benadryl, Motrin, Rolaids, St. Joseph and Sudafed.

Recalled Johnson & Johnson products