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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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  • Genetic discovery could lead to better prediction of suicide risk within families November 26, 2020
    Every 11 minutes, an American dies by suicide. That's 132 people a day or more than 48,000 annually. For those left behind, the haunting question is why.
  • The genetics of side-effects November 25, 2020
    Henk-Jan Guchelaar knows all too well the serious problems that the side-effects of medication can cause. As a professor of clinical pharmacy at the University of Leiden in the Netherlands, he has spent the last two decades trying to get the link between medicine and our genes recognised more widely.
  • Gene donors at high risk for cancer received feedback November 25, 2020
    Researchers at the Estonian Genome Center at the University of Tartu studied how people at high risk for breast, ovarian or prostate cancer responded to the feedback of genetic findings. Gene donors who chose to receive results appreciated being contacted and considered the information provided to be valuable. Authors find that knowing more about people's […]
  • Researchers reveal how genetic variations are linked to COVID-19 disease severity November 25, 2020
    Even as tens of thousands of Americans test positive for COVID-19 each day, physicians still aren't sure why some people experience mild to no symptoms while others become critically ill. New research led by Robert E. Gerszten, MD, Chief of the Division of Cardiovascular Medicine at Beth Israel Deaconess Medical Center (BIDMC) sheds new light […]
  • Study identifies new functions in the gene that causes Machado-Joseph disease November 25, 2020
    Ataxia is a minority disease with genetic origins, known for its neuromuscular alterations due to the selective loss of neurons in the cerebellum, the organ of our nervous systems which controls movement and balance. UB researchers have identified new functions in the ataxin 3 gene (ATXN3)–which causes Machado-Joseph disease, the most common type of ataxia– […]
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