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Posted in Allelic Variant, New Drug Approval, Regulatory Approval, Targeted Therapy, Thasso Post, Theragenomic Medicine
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May 30, 2019 – The American Food and Drug Administration (FDA) recently approved Alpelisib (Piqray)Â to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative,
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thassodotcom
Posted in Adverse Drug Reaction [ADR], New Safety Information, Regulatory Announcement, Thasso Post, Theragenomic Medicine
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March 21, 2017 – Health Canada just communicated this important safety information: Cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) under treatment of patients with Pembrolizumab (Keytruda) have been reported internationally in the clinical trials and post-marketing setting.
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Dao RL, Su SC, Chung WH
Posted in Adverse Drug Reaction [ADR], Genetic Predisposition, Thasso Post, Theragenomic Medicine
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September 26, 2016 – Toxic epidermal necrolysis (TEN), also known as Lyell’s syndrome, is a rare, life-threatening skin condition that is usually caused by a reaction to drugs. The disease causes the top layer of skin (the epidermis) to detach from the lower layers of the skin (the dermis),
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thassodotcom
Posted in Allelische Variante, Keine Kategorie, Personalized Medicine, Pharmacogenetics, Thasso Post
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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 for novel, inventive cancer treatments. See here in italics his statement:
 When we talk about precision medicine and personalized medicine,
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May 09, 2013 – This is from the News and Press Release Archive of the European Medicines Agency (EMA) as of April 29, 2013. Find here the unedited release in full:
29/04/2013
Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh
Following the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC),
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