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Sitaxentan [Thelin] to be withdrawn from market worldwide due to cases of unpredictable serious liver injury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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  • Newly discovered mutation could point to heart disease therapeutic target August 7, 2020
    New work led by Carnegie's Meredith Wilson and Steve Farber identifies a potential therapeutic target for clogged arteries and other health risks that stem from an excess of harmful fats in the bloodstream. Their findings are published by PLOS Genetics.
  • Genetic cause of congenital malformation discovered August 7, 2020
    Spontaneous mutations of a single gene are likely to cause serious developmental disorders of the excretory organs and genitalia. This is shown in an international study led by the University of Bonn and published in the journal Frontiers in Cell and Developmental Biology. The researchers also owe their findings to an unusual model organism: the […]
  • Novel approach reduces SCA1 symptoms in animal model August 7, 2020
    Research has shown that a mutation in the ATAXIN-1 gene leads to accumulation of Ataxin-1 (ATXN1) protein in brain cells and is the root cause of a rare genetic neurodegenerative disease known as spinocerebellar ataxia type 1 (SCA1). How healthy cells maintain a precise level of ATXN1 has remained a mystery, but now a study […]
  • Alport Syndrome: Research highlights link between genotype and treatment effectiveness August 7, 2020
    A large-scale analysis of the clinical characteristics of Alport syndrome in Japanese patients has revealed that the effectiveness of existing treatment with ACE inhibitors and/or angiotensin receptor blockers (RAS inhibitors) varies depending on the type of mutation in the syndrome's causal gene (COL4A5). RAS inhibitors are widely administered to patients with chronic kidney diseases as […]
  • Tasmanian devil research offers new insights for tackling cancer in humans August 6, 2020
    A rare, transmissible tumor has brought the iconic Tasmanian devil to the brink of extinction, but new research by scientists at Washington State University and the Fred Hutchinson Cancer Research Center in Seattle indicates hope for the animals' survival and possibly new treatment for human cancers.
  • checkmate 743 shows that dual immunotherapy, nivolumab + ipilimumab August 8, 2020
    The combination of first-line nivolumab and ipilimumab demonstrated an improvement of overall survival for patients with unresectable malignant pleural mesothelioma compared to platinum-based chemotherapy, according to research presented today at the International Association for the Study of Lung Cancer Virtual Presidential Symposium.
  • Phase 3 eXalt3 study shows significantly longer progression-free survival August 8, 2020
    Patients with non-small cell lung cancer (NSCLC) carrying anaplastic lymphoma kinase (ALK) gene alterations who received ensartinib experienced substantially longer progression-free survival than a matched group of patients who received crizotinib.
  • Addition of sintilimab to pemetrexed and platinum improved progression-free survival August 8, 2020
    The interim analysis of ORIENT-11, a phase III double-blind randomized trial has shown a nearly two-fold increase in progression-free survival with addition of sintilimab to chemotherapy in patients with advanced or metastatic non-squamous non-small cell lung cancer without EGFR or ALK genomic aberrations, according to research data presented today at the International Association for the […]
  • Heart attack case rates, treatment approaches, outcomes during COVID-19 pandemic August 7, 2020
    The increases and decreases in patient volume and associated changes in treatment experienced by individuals presenting with acute heart attack (myocardial infarction) before and immediately after the onset of the COVID-19 pandemic are examined in this observational study.
  • COVID recovery choices shape future climate August 7, 2020
    A new international study, led by the University of Leeds, warns that even with some lockdown measures staying in place to the end of 2021, without more structural interventions global temperatures will only be roughly 0.01°C lower than expected by 2030. However, the study estimates that including climate policy measures as part of an economic […]
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