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Pembrolizumab (Keytruda): Clinical trials on hold

September 2, 2017 – The American Food & Drug Administration (FDA) has announced that two clinical trials with Pembrolizumab (Keytruda) in patients with multiple myeloma have been put on hold. The FDA informs the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Pembrolizumab (Keytruda) in combination with dexamethasone and an immunomodulatory agent (Lenalidomide (Revlimid) or Pomalidomide (Pomalyst)) for the treatment of patients with multiple myeloma.

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Orlistat: Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers

August 30, 2016 – The present article which just appeared in August 2016 issue of  PLOS Medicine illustrates how the inaccurate and biased to say the least the assessment and the reporting of adverse drug reactions by pharmaceutical companies throughout study protocols, investigators brochures,

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Immunemodulation: Cancer drug trial halted after three test subjects die

July 12, 2016 – The American Food & Drug Administration (FDA) has notified Juno Therapeutics Inc. that a clinical hold has been placed on the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), known as the “ROCKET” trial.

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The betrayed educated patient: A significant percentage of completed clinical trials on drugs are never published

May 01, 2016 – The present post addresses a very disturbing issue in connection with clinical trials and the disclosure of the results in public. The cited study throws a dubios light on the readiness of sponsors to inform patients, i.e. their future end user clients, on the outcome of clinical trials and to openly divulge pros and cons of their products.

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Under scrutiny: The EMA reviews cancer medicine Idelalisib (Zydelig) after the occurrence of serious adverse effects, some of them fatal, in three clinical trials

 March 20, 2016 – The European Medicines Agency (EMA) has, at the request of the European Commission, has started a review of the cancer medicine Idelalisib (Zydelig), which is authorised in the European Union to treat two types of rare blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL) (one of a group of cancers called Non-Hodgkin lymphoma).

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New Treatment Modality: Nivolumab (Opdivo) has been approved for the treatment of patients with previously treated metastatic squamous non-small cell lung cancer (NSCLC)

June 17, 2015 – Bristol Myers Squipp recently announced that the U.S. Food and Drug Administration (FDA) has approved Nivolumab (Opdivo) injection, for intravenous use, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. 

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  • 30-year study identifies need of disease-modifying therapies for maple syrup urine disease January 24, 2020
    A new study analyzes 30 years of patient data and details the clinical course of 184 individuals with genetically diverse forms of Maple Syrup Urine Disease (MSUD), which is among the most volatile and dangerous inherited metabolic disorders. Researchers collected data on survival, hospitalization rates, metabolic crises, liver transplantation, and cognitive outcome. This represents the […]
  • TP53 gene variant in people of African descent linked to iron overload, may improve malaria response January 24, 2020
    In a study by The Wistar Institute and collaborators, a rare, African-specific variant of the TP53 gene called P47S causes iron accumulation in macrophages and other cell types and is associated with poorer response to bacterial infections, along with markers of iron overload in African Americans. Macrophage iron accumulation disrupts their function, resulting in more […]
  • Scientists highlight potential of exposome research January 23, 2020
    Over the last two decades, the health sciences have been transformed by genomics, which has provided insights into genetic risk factors for human disease. While powerful, the genomics revolution has also revealed the limits of genetic determinants, which account for only a fraction of total disease risk. A new article in the journal Science argues […]
  • Researchers uncover mechanism for how common gene therapy vectors enter cells January 23, 2020
    Researchers led by a team at Massachusetts Eye and Ear have identified a novel cellular entry factor for adeno-associated virus vector (AAV) types—the most commonly used viral vectors for in vivo gene therapy. AAVs are vectors—or vehicles—that are created from a virus that is made harmless by molecular engineering, and have shown promise transporting genetic […]
  • Largest-ever study ties over 100 genes to autism January 23, 2020
    More than 100 genes appear to be involved in autism spectrum disorders (ASD), according to the largest genetic study of the condition to date.
  • More than 40% of status epilepticus patients suffer adverse outcomes January 24, 2020
    A new study published in Seizure gives insight into the short-term outcome of patients treated for status epilepticus in Kuopio University Hospital in Finland. The researchers found a 9% risk of death and a 32% risk of functional loss at one month after status epilepticus. The patient's risk of death could be predicted relatively reliably […]
  • A new twist on quantum communication in fiber January 24, 2020
    New research done at the University of the Witwatersrand in Johannesburg, South Africa, and Huazhang University of Science and Technology in Wuhan, China, has exciting implications for secure data transfer across optical fiber networks.
  • The regulators active during iron deficiency January 24, 2020
    Iron deficiency is a critical situation for plants, which respond using specific genetic programmes. Biologists from Heinrich Heine University Düsseldorf (HHU) and Michigan State University (MSU) used artificial intelligence methods to examine how to predict regulatory genetic sequences. They have now published the findings from their joint research work in the journal Plant Physiology.
  • Brain-cell helpers powered by norepinephrine during fear-memory formation January 24, 2020
    A sustained state of vigilance will generate a different type of memory than a momentary startle, and these differences are linked to distinct signaling molecules in the brains of mice. Researchers at the RIKEN Center for Brain Science (CBS) have visualized these dynamics in the living mouse brain for the first time, observing two molecular […]
  • What goes up may actually be down January 24, 2020
    A new study in Frontiers in Neuroscience used virtual reality to determine how people plan their movements by 'seeing' gravity using visual cues in the landscape around them, rather than 'feeling it' through changes in weight and balance.
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