Blog Archives

Living theragenomic medicine: Direct to consumer test for metabolism of drugs FDA approved

November 08, 2018 –  The American Food and Drug Administration (FDA) has just authorized the first direct-to-consumer test for detecting genetic variants in genes that may govern the metabolism of drugs in individual patients.

Thus, FDA permits marketing, with special controls,

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Lutetium 177 dotatate (Lutathera): A treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

January 29, 2018 – Gastroenteropancreatic neuroendocrine tumors (GEP-NET)s are a rare group of cancers with limited treatment options that affects primarily the pancreas or gastrointestinal tract of patients.  

The American Food &

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X-linked Hypophosphatemia: Burosumab (Crysvita) to the rescue

 December 16, 2017 – As recent as of December 14, 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Burosumab (Crysvita),

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Besponsa: Is this really a viable new treatment for ALL?

August 18, 2017 – B-cell precursor acute lymphoblastic leukemia (ALL) is a aggressive and rapidly progressing type of cancer in which the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell. In the United States, the National Cancer Institute estimates that approximately 5,970 people will be diagnosed with B-cell ALL this year and approximately 1,440 will die from the disease.

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Rare diseases: EU and US collaborate to boost development of therapies

September 30, 2016 – This is very good news for patients suffering from any form of a rare disease. The European Medicines Agency (EMA) and the American Food and Drug Administration (FDA) have engaged in a joint effort to boost development of medicines for rare diseases.

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Palbociclib (Ibrance): New treatment for advanced or metastatic breast cancer in the EU

 September 17, 2016 – Breast cancer is the most common cancer in women worldwide, with nearly 1.7 million new cases diagnosed in 2012. In Europe, there were an estimated 464,000 new cases of breast cancer in 2012 and an estimated 131,000 deaths from the disease. Hormone receptor positive breast cancer accounts for 65% of tumours in women aged 35 to 65 years and 82% of tumours in women older than 65 years.

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Patient safety: EMA recommends suspension of medicines over flawed studies

August 08, 2016 –The following publication has just been released by the EMA. Because Thasso Post is not only about theragenomic and personalized medicine, but also about the safety of medicines for each individual patient, thasso feels that this is important information which highlights the degree of scrutiny applied by authorities in the quest to guarantee the quality and safety of approved medicines.

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With Infliximab (Flixabi), a huge biosimilar medicine has been approved in the European Union (EU)

 June 22, 2016 – The European Medicines Agency (EMA) has approved, as of the end of May 2016, Infliximab (Flixabi). Infliximab (Flixabi) is a monoclonal antibody that has been designed to attach to a protein called tumour necrosis factor-alpha (TNF-alpha) and block its activity.

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Are first-in-man (FIM) clinical trials unsafe?

June 01, 2016 – Are first-in-man (FIM) clinical trials unsafe? This question can certainly be answered with no, first-in-man (FIM) clinical trials (clinical Phase I studies) are generally not unsafe. In spite of this notion, and in the wake of the tragic incident which took place during a Phase I first-in-man (FIM) clinical trial in Rennes,

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EMA: Two new combination therapies against chronic hepatitis C recommended for approval

May 30, 2016 – According to its News and Events section of the homepage, the European Medicines Agency (EMAhas recommended the granting of marketing authorisations in the European Union (EU) for two new combination therapies against chronic (long-term) hepatitis C virus (HCV) infection,

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