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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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  • Researchers find genetic links to child obesity across diverse ethnic groups August 22, 2019
    An international team of researchers who analyzed data across multiple ethnicities has produced the largest genetic study to date associated with common childhood obesity. The Early Growth Genetics (EGG) Consortium discovered a robust new signal, fine-mapped previously reported genetic variants, and added to evidence that genetic influences on obesity operate across the lifespan.
  • Researchers develop model to personalize radiation treatment August 22, 2019
    A personalized approach to cancer treatment has become more common over the last several decades, with numerous targeted drugs approved to treat particular tumor types with specific mutations or patterns. However, this same personalized strategy has not translated to radiation therapy, and a one-size-fits-all approach for most patients is still common practice. Moffitt Cancer Center […]
  • How our genes and environment influence BMI and height August 22, 2019
    Environmental conditions influence our body mass index (BMI) by increasing or decreasing the effect of inherited genetic variations, University of Queensland researchers have discovered.
  • Genetic testing and family tree research are revealing painful family secrets, research says August 22, 2019
    Genealogical research and genetic testing are revealing skeletons in family closets and causing rifts among members, a new study shows.
  • Researchers use single-cell sequencing to get a better look at human embryo implantation August 22, 2019
    A team of researchers affiliated with multiple institutions in China has used single-cell sequencing to learn more about the human embryo during implantation in the uterus. In their paper published in the journal Nature, the group describes sequencing thousands of human embryo cells from before, during and after implantation, and what they learned from it.
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