Blog Archives

Vemurafenib [Zelboraf] Approved Together with a Companion Diagnostic Test by FDA for Advanced Melanoma in BRAF V600E Positive Patients

August 17, 2011 — The US Food and Drug Administration (FDA) has just approved the oral targeted therapy Vemurafenib [Zelboraf] for the first-line treatment of both metastatic and unresectable melanomas. The drug is specifically indicated for patients with melanoma whose tumors have V600E mutations in the BRAF gene. An estimated 50% of patients with melanoma have this type of BRAF mutation,

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Heart Medication Dronedarone [Multaq]: Risk of Severe Liver Injury

January 14, 2011 – The American Food and Drug Administration (FDA) notified today healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication Dronedarone [Multaq].

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Sitaxentan [Thelin] to be withdrawn from market worldwide due to cases of unpredictable serious liver injury

December 13, 2010 – We learn today that the European Medicines Agency (EMEA) has been informed of Pfizer’s decision to voluntarily withdraw Sitaxentan [Thelin] from the market worldwide further to new information on two cases of fatal liver injury. Pfizer has also decided to discontinue all ongoing clinical trials.

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Sibutramine [Meridia]: Market Withdrawal Due to Risk of Serious Cardiovascular events

October 08, 2010 – Today, we learn that Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary market withdrawal of Sibutramine [Meridia], an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.

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Lamotrigine [Lamictal]: DrugLabel Change Because Risk of Aseptic Meningitis

2010-08-15 – From a recent health safety alert  we learn that  FDA notified healthcare professionals and patients that Lamotrigine [Lamictal], a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic meningitis. Symptoms of meningitis may include headache,

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Eltrombopag [Promacta]: Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease

May 13, 2010 – The American Food and Drug Administration (FDA) posted yesterday the following Safety Information Text (italic):

GlaxoSmithKline and FDA notified healthcare professionals of a new safety finding in patients with thrombocytopenia due to chronic liver disease treated with Eltrombopag [Promacta],

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European Medicines Agency (EMEA) recommends revocation of marketing authorisation for bufexamac containing medicines.

April 27, 2010 – From an announcement by the EMEA we learn that bufexamac-containing medicines were to be taken off EU markets because of high risk of contact allergies.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that marketing authorisations for bufexamac- containing medicines be revoked.

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  • Citizen science and paddle surf to study microplastic pollution in Barcelona's coastline February 27, 2020
    A team of the University of Barcelona has studied for the first time the presence of microplastics in the coasts of Barcelona, with the collaboration of the citizens gathering scientific samples. The study, published in the journal Science of Total Environment, is a pioneer citizen science study worldwide, since it analyses a hard-access area for […]
  • Celiac disease might be cured by restoring immune tolerance to gliadin February 27, 2020
    Celiac disease affects 0.3-2.4% of people in most countries world-wide, and approx. 2% in Finland. Celiac patients suffer from a variety of symptoms, typically intestinal complaints, such as diarrhea, but are often symptom-free. Immunologist Tobias Freitag co-developed and tested nanoparticles containing gliadin for the immunomodulatory treatment of celiac disease in Professor Seppo Meri's research group […]
  • Abnormal growth of bacterial cells could be linked to anti-microbial resistance February 27, 2020
    Scientists from the University of Surrey have identified mutations in a gene in an Escherichia coli (E.coli) model that could help explain a form of anti-microbial resistance (AMR) known as 'persistence'.
  • Study unravels how our immune system deals with fungal and viral infections February 27, 2020
    The body's immune response to fungal infections changes when a patient is also infected by a virus, according to new research which investigated the two types of infection together for the first time.
  • How the brain separates words from song February 27, 2020
    The perception of speech and music -- two of the most uniquely human uses of sound -- is enabled by specialized neural systems in different brain hemispheres adapted to respond differently to specific features in the acoustic structure of the song, a new study reports.
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