June 23, 2022 – Expansion of pharmacogenetics education agreed as part of lawsuit settlement. This has just been the headline objective of one of the latest blogs from the PharmGKB blogspot, an NIH-funded resource (database) that provides information about how …

Real world theragenomics and personalised medicine Read more »

May 01, 2021 – Fish oil supplements are a billion-dollar industry built on a foundation of a huge array of studies, sometimes with contra-dictionary outcomes, indicating a reduction of serum triglycerides (TAGs) but somewhat mixed effects on other circulating cardiovascular biomarkers. Genetic …

Fish oil: Your genotype may tell you to take it or not Read more »

December 28, 2020 – Some 95% of people have gene variants that may negatively affect their response to at least one drug, leading to unexpected or adverse drug reactions (ADRs) or, if unlucky, to a serious, if not fatal, adverse …

Genetics behind some serious adverse drug reactions (SADRs) Read more »

January 26, 2020 – An effort to map thousends of genomes across Asia has certainly the potential to find novel gene variants affecting disease and responses to drugs, and to reveal the complex origins of Asian populations. In a pilot …

The diversity of Asian genomes Read more »

August 06, 1015 – The American Food and Drug Administration (FDA) has just issued a warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Fingolimod (Gilenya) for …

Fingolimod (Gilenya): Warning about rare cases of progressive multifocal leukoencephalopathy (PML) Read more »

February 8, 2015 – The American Food and Drug Administration (FDA) has granted accelerated approval to Palbociclib (Ibrance) to treat advanced (metastatic) breast cancer.  The FDA granted Ibrance breakthrough therapy designation because the sponsor demonstrated through preliminary clinical evidence that the …

Theragenomic Medicine: Palbociclib (Ibrance) approved for postmenopausal women with advanced (metastatic) breast cancer Read more »

November 20, 2014 –  Recent research has addressed the clinically strikingly wide variation among patients in plasma levels of Atorvastatin (Lipitor) and Rosuvastatin (Crestor), even with consistent dosing. This research proposes that the phenomenon is likely related to gene variants …

Theragenomic Medicine: Genotyping Might Cut Muscle-Pain Risk with Statin Drugs Read more »

October 05, 2014 – To strengthen the safety of medical devices, the U.S. Food and Drug Administration has finalised and released recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. The final guidance, titled “Content …

Steps to strengthen cybersecurity of medical devices Read more »

September 27, 2014 – A while ago (August 2012),  the American Food and Drug Administration (FDA) was assessing and reporting on the (possibly fatal) risks associated with the use of codeine containing medicines in children who are phenotypically members of the …

FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death Read more »

August 1. 2014 – The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk …

US: Approval of Alglucosidase Alfa [Lumizyme] to treat Pompe disease expanded to patients of all ages Read more »