June 22, 2014 – The individuum (i.e., patient) is the phenotype expert on her/his individualized form of proper disease she/he is suffering from. It is not her/his treating physician, it is not a regulatory person concerned with the safety and …

The Apomediary [Patient Expert] and Personalized Medicine: A Commentary Read more »

June 20, 2014 – The genetic bad actor BRCA2 has been implicated in yet another cancer. The gene is known to increase risk for breast and ovarian cancers. Now, as a new genomic study shows, a rare variant of the …

BRCA2 Variant Linked to Lung Cancer Risk Read more »

Apple has unveiled HealthKit, a platform to centralise data from different types of devices, like fitness trackers, heart rate and blood pressure monitors. Launching iOS 8 for iPhones and iPads, which it describes as the biggest release since the launch …

Apple plan to revolutionize mobile healthcare: Personalized medicine at the horizon on the iPhone and the likes Read more »

June 02, 2014 – Today, the American Food & Drug Administration (FDA)  announced the launch of openFDA, a new initiative from their Office of Informatics and Technology Innovation (OITI). OpenFDA is specifically designed to make it easier for developers, researchers, and the public to access …

OpenFDA: Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data Read more »

May 31, 2014 – This article is from the latest issue of the ANL Magazine. – Researchers at the University of California, San Diego School of Medicine have identified a therapeutic target for treating the most common form of eye cancer …

Melanoma of the Eye Caused by Two Gene Mutations Read more »

May 27, 2014 – Health Canada informed us today that rare cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported in patients treated with Panitumumab (Vectibix), and advises as follows: Cases of Stevens-Johnson syndrome (SJS) and Toxic …

Panitumumab (Vectibix) – Rare Cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) Read more »

May 27, 2014 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a conditional marketing authorisation for Translarna (ataluren), an orphan-designated medicine for the treatment of Duchenne muscular dystrophy caused by nonsense mutations. …

European Medicines Agency (EMA) recommends Ataluren (Translarna) as a first-in-class medicine for treatment of Duchenne Muscular Dystrophy Read more »

May 22, 2014 – The U.S. Food and Drug Administration  approved  on May 20, 2014, Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease. Entyvio is approved to …

Vedolizumab [Entyvio]: FDA approves Entyvio to treat ulcerative colitis and Crohn’s disease Read more »

May 15, 2014 –  The U.S. Food and Drug Administration recently approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a …

FDA approved Vorapaxar [Zontivity] to reduce the risk of stroke and heart attacks in high-risk patients Read more »

May 13, 2014 – The Pradaxa story continues. See the latest MedWatch Drug Safety Communication, posted on 05/13/2014. ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke,  bleeding …

Dabigatran (Pradaxa) Drug Safety Communication: Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin Read more »