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first-in-human

This page shows the latest first-in-human news and features for those working in and with pharma, biotech and healthcare.

Hesperos’ ‘human-on-a-chip’ predicts drug toxicity in the lab

Hesperos’ ‘human-on-a-chip’ predicts drug toxicity in the lab

Drug discovery potential. Lab models that mimic the human heart and liver systems were able to correctly predict the toxicity of two test drugs in a study, reinforcing their potential as ... Hesperos says this is “the first time an in vitro

Latest news

  • Encouraging early data for Amgen’s BiTE therapies Encouraging early data for Amgen’s BiTE therapies

    Including first-in-man data from prostate cancer drug. Amgen has showcased some encouraging early stage data from candidates based on its novel bispecific T cell engager (BiTE) platform at ASCO. ... There were also initial results from a first-in-human

  • Non-antibiotic could ‘transform pneumonia therapy’ Non-antibiotic could ‘transform pneumonia therapy’

    Lancet hails study as medical breakthrough. Swiss biotech Combioxin has published the first clinical data on a new way to treat serious infections, by neutralising toxins made by pathogens. ... The small first-in-human study – involving 19 patients who

  • Sangamo surges on data for haemophilia A gene therapy Sangamo surges on data for haemophilia A gene therapy

    the wake of the announcement of data from just eight patients in a phase 1/2 trial. ... The data is a boost to Sangamo, which came under pressure in February after reporting disappointing first human data from  SB-913, the lead drug drug based on its

  • GSK’s myeloma drug hits target, prompting rapid filing pledge GSK’s myeloma drug hits target, prompting rapid filing pledge

    GSK2857916 is an anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, and results from the DREAMM-1 first-in-human open label trial showed that 60% of patients  achieved an ... A higher dose is also being assessed in the ongoing phase 1 study.

  • FDA lifts hold on Vertex and CRISPR Therapeutics sickle cell therapy FDA lifts hold on Vertex and CRISPR Therapeutics sickle cell therapy

    The US regulator placed a hold on the trial in May, which could now become the first in human trials of the CRISPR technology. ... produce high levels of foetal haemoglobin (HbF; haemoglobin F) in red blood cells.

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Latest Intelligence

  • The global antibiotic crisis: a 2020 perspective The global antibiotic crisis: a 2020 perspective

    COT-143 has already produced encouraging results in preclinical studies and has shown to be safe in regulatory toxicology tests in preparation for first-in-human clinical trials. ... NDM-1, for example, was first identified in 2008 and has already caused

  • Rethinking trials: the pros and cons of protocol amendments Rethinking trials: the pros and cons of protocol amendments

    Earlier phase studies, such as phase 1 a/b, first-in-human or dose escalations with or without combination, typically require fewer amendments than trials in later phases of development,” Learn ... in addition to those resulting purely from the drug

  • 30 Women Leaders in UK Healthcare 30 Women Leaders in UK Healthcare

    for Lynparza, the first in class PARP inhibitor now approved in ovarian and breast cancers. ... treatments for first-in-human trials.

  • Pharma deals in August 2015 Pharma deals in August 2015

    First mooted in December 2014, the companies had entered into a broad strategic alliance covering a five year period as part of an open innovation initiative. ... As the first approved product for this disorder the US launch is expected in October.

  • The balance of power in healthcare The balance of power in healthcare

    Parsa said: “For the first time in human history we can do with your body what we are already doing with your car, which is continuously checking the engine before moving ... For the first time in history, people will have the 'check engine' capability

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Latest appointments

  • Industry appointments Industry appointments

    Greenberg brings more than 35 years to Allergan’s board and this appointment marks the fifth new director in 18 months. ... Most recently, Hassan built the oncology-focused biology, preclinical and biomarker units for Immunocore, overseeing early

  • Swiss biotech Inositec appoints new chief medical officer Swiss biotech Inositec appoints new chief medical officer

    These innovative products have the potential to significantly advance patient care in vascular and other calcification disorders, all with high unmet medical need.”. ... in the vascular calcification space and fine-tune our clinical strategy in view of

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