October 10, 2013 – Very recently, David Kerr, Professor of Cancer Medicine at University of Oxford, in the United Kingdom, and past President of the European Society for Medical Oncology, talked on Medscape (see the video here) about risk-benefit analyses …

Can We Identify Risk for Drug Toxicity? Read more »

January 26, 2012 – I am relaying the information below by the EMA to the readers of this blog. It might be interessting to dwell into this concept paper (as a scientist, a treating physician, or an informed patient) for informations only or even …

EMA: Public consultation open on concept paper on pharmacogenomics in evaluation of authorised medicines Read more »

January 26, 2012 – A January 20, 2012 article in Medscape Medical New illustrates how personalized medicine can be tricky. The case is Vemurafenib [Zelboraf], which was introduced to the market together with an companion genetic test mid 2011 for the treatment of advanced …

Patients on Vemurafenib [Zelboraf] Need Testing for RAS Mutations: Secondary Cancers a Major Concern Read more »

August 26, 2011 – Today, the  American Food and Drug Administration (FDA) has approved Crizotinib [Xalkori] to treat the patient subgroup with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) whos cancers express (i.e., test positive for the …

FDA Approves Crizotinib [Xalkori] with Companion Diagnostic Test for Non-Small Cell Lung Cancers (NSCLC) Positive for the Anaplastic Lymphoma Kinase (ALK) Gene Read more »

March 17, 2010 – The U.S. Food and Drug Administration (FDA) has added a Boxed Warning to the label for Clopidogrel [Plavix], the anti-blood clotting medication. The Boxed Warning is about patients who do not effectively metabolize the drug (i.e. …

FDA Drug Safety Communication: Reduced effectiveness of Clopidogrel [Plavix] in patients who are poor metabolizers (i.e. carriers of selected CYP2C19 allelic variants) of the drug Read more »