Blog Archives

Therapies that promote progressive multifocal leukoencephalopathy (PML)

August 23, 2019 – Progressive multifocal leukoencephalopathy (PML) is a rare and often fatal viral disease characterized by progressive damage or inflammation of the white matter of the brain at multiple locations (i.e., multifocal). It is caused by the JC virus,

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Ofatumumab (Arzerra) approved for recurrent or progressive chronic lymphocytic leukemia (CLL)

January 20, 2016 – The American Food and Drug Administration (FDA) just approved Ofatumumab (Arzerra)  Injection for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). 

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

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 multiple sclerosis (MS).

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Theragenomic medicine: First case of fumarate-linked progressive multifocal leukoencephalopathy (PML) in nonlymphopenic patient

April 11, 2015 – Dutch clinicians report what they believe is the first case of progressive multifocal leukoencephalopathy (PML) after treatment with compounded dimethyl fumarate (DMF) in a patient without severe lymphocytopenia. This situation was “previously thought to be unlikely,” Dennis Nieuwkamp,

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First Case of Progressive Multifocal Leukoencephalopathy (PML) in a Patient Treated with Dimethyl Fumarate [Tecfidera]

November 7, 1014 –  This report originates from the meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) on 3-6 November 2014 at EMA.

At this meeting, the PRAC took note and advised on informing about first case of PML in a patient treated with Tecfidera.

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Vedolizumab [Entyvio]: FDA approves Entyvio to treat ulcerative colitis and Crohn’s disease

May 22, 2014 – The U.S. Food and Drug Administration  approved  on May 20, 2014, Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease. Entyvio is approved to treat those conditions when one or more standard therapies (corticosteroids,

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Drug Safety Communication on Brentuximab Vedotin [Adcetris] – Progressive Multifocal Leukoencephalopathy (PML) and Pulmonary Toxicity

January 16, 2012 – The American Food and Drug Administration ( FDA) released on January 13, 2012 the following drug safety communication:

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ISSUE: FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death,

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Belatacept [Nulojix]: Increased Risk of Post-Transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML)

July 7, 2011 – Bristol-Myers Squibb (BMS) today informed healthcare professionals about a REMS (Risk Evaluation and Mitigation Strategy) that is required for Belatacept [Nulojix] to ensure that the benefits of Belatacept [Nulojix] outweigh the risks of Post-Transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML), both of which can be fatal.

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When is a drug too risky to stay on the market?

July 04, 2010 – The arthritis pill Rofecoxib [Vioxx] was withdrawn from the market but menopause hormones were not, even though both were tied to heart risks. A multiple sclerosis medicine was pulled and later allowed back on. So, when is a drug too risky to stay on the market?

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Rituximab [Rituxan] – Progressive Multifocal Leukoencephalopathy [PML]

October 23, 2009 – Today, Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituximab [Rituxan] who has not previously received treatment with a TNF antagonist.

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  • Tick, tock: How stress speeds up your chromosomes' aging clock December 5, 2019
    Ageing is an inevitability for all living organisms, and although we still don't know exactly why our bodies gradually grow ever more decrepit, we are starting to grasp how it happens.
  • Genome testing for siblings of kids with autism may detect ASD before symptoms appear December 5, 2019
    One of the key priorities of interventions for autism spectrum disorder (ASD) is starting early, with some evidence showing infants as young as seven months old could benefit. Yet, most children in North America aren't diagnosed with ASD until they're over four years of age. New research led by The Hospital for Sick Children (SickKids) […]
  • 2019: the year gene therapy came of age December 5, 2019
    In the summer, a mother in Nashville with a seemingly incurable genetic disorder finally found an end to her suffering—by editing her genome.
  • Scientists create 'epigenetic couch potato' mouse December 4, 2019
    Why is it that some people love to exercise, and others hate it? Most people would assume it's all due to genetics, but a new Baylor College of Medicine led study in mice shows for the first time that a different molecular level of regulation—epigenetics—plays a key role in determining one's innate drive to exercise. […]
  • Human genetic enhancement might soon be possible—but where do we draw the line? December 4, 2019
    The first genetically edited children were born in China in late 2018. Twins Lulu and Nana had a particular gene—known as CCR5—modified during embryonic development. The aim was to make them (and their descendants) resistant to HIV. By some definitions, this would be an example of human enhancement.
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