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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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  • Child care centers rarely require flu vaccination for children or their caregivers December 12, 2019
    Influenza can be especially dangerous for children, who are at greater risk for serious complications from the illness, including hospitalization and even death. Yet child care centers in the US rarely require children or the adults who care for them to be vaccinated against flu, according to a new study published in the Journal of […]
  • Antiarrhythmic drug identified as potential treatment for pulmonary arterial hypertension December 12, 2019
    High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a potentially fatal disease caused by obstruction of blood flow in the lungs. A new study in The American Journal of Pathology, published by Elsevier, sheds light on the pathology underlying PAH and shows that dofetilide, an FDA-approved KV11.1 channel blocker for […]
  • Nurses sleep less before a scheduled shift, hindering patient care and safety December 12, 2019
    Nurses sleep nearly an hour and a half less before work days compared to days off, which hurts patient care and safety, finds a new study by researchers at NYU Rory Meyers College of Nursing. The findings are published in Sleep Health, the journal of the National Sleep Foundation.
  • Veterans study suggest two sub-types of Gulf War illness December 12, 2019
    Brain imaging of veterans with Gulf War illness show varying abnormalities after moderate exercise that can be categorized into two distinct groups -- an outcome that suggests a more complex illness that previously thought.
  • Baby's first breath: A new method for helping preemies to breathe December 12, 2019
    Two new studies in Frontiers in Pediatrics demonstrate that giving premature babies 100% oxygen via face-mask immediately after birth can jump start independent breathing and minimize the amount of ventilation assistance these babies will need.
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