June 25, 2014 -The genetics startup 23andMe said on Friday it is one step closer to resuming sales of its full-fledged health product, with the U.S. Food and Drug Administration accepting its first health report for review. The home genetics …

Genetics Startup 23andMe takes Step on Path to FDA Approval Read more »

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 »

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 01, 2014 – This is a fantastic article on a very difficult to understand topic, with often very sad outcomes.  The source of the article is Medscape and it reveals how combined efforts from different scientific appoaches may lead …

Just Wait A Little Longer: Suicide Biomarkers Getting Closer to the Clinic Read more »

April 30, 2014 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E mutation. Mekinist …

European Medicines Agency (EMA) recommends approval of Trametinib [Mekinist] for the treatment of melanoma with a BRAF V600E mutation Read more »

April 25, 2014 – This article just appeared in Medscape Oncology. It is a good example to illustrate that also effective chemoprevention (of cancer) may largely depend on the genetic makeup of the individual (patient). The case is about the …

Personalized Medicine: The benefit of Acetylsalicylic Acid [Aspirin] in preventing colorectal cancer seems to depend on the expression level of the 15-PGDH gene in the individual Read more »

April 18, 2014 – Have you ever heard of Mucopolysaccharidosis Type IVA (Morquio A syndrome)? Most probably not.  And I would also think that only very few people are familiar with the “Rare Pediatric Disease Priority Review Voucher Program” by …

FDA approves Elosulfase Alfa [Vimizim] to treat the rare congenital enzyme disorder Mucopolysaccharidosis Type IVA (Morquio A syndrome) Read more »

April 13, 2014 – The American Food and Drug Administration (FDA) has issued a new Boxed Warning for Valproic Acid [Stavzor] and its association with drug induced liver disease (hepatotoxicity, hepatic failure) which may be fatal in some patients. We …

Valproic Acid [Stavzor]: Newly issued boxed warning for life-threatening liver disease Read more »