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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.

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.

Latest news

  • A look ahead to key trial readouts at ESMO A look ahead to key trial readouts at ESMO

    In immuno-oncology, this year’s offering includes a first showing for data in first-line advanced renal cell carcinoma for Merck KGaA/Pfizer’s Bavencio (avelumab) in the JAVELIN Renal ... Looking at some of the new mechanisms on show, Merck/MSD will

  • Darzalex powers ahead with frontline myeloma approval in Europe Darzalex powers ahead with frontline myeloma approval in Europe

    It’s all the more remarkable considering it has only been ten years since the first dose of daratumumab was administered in the earliest human studies, ”said Dr Torben Plesner, MD, ... the first investigator to administer daratumumab in human trials

  • Pfizer signs $425m flu vaccine deal with Germany’s BioNTech Pfizer signs $425m flu vaccine deal with Germany’s BioNTech

    they pass the phase I first-in-human clinical trial stage. ... first human trial of a freeze-dried mRNA vaccine candidate.

  • DNA damage specialists Artios Pharma raises $84m DNA damage specialists Artios Pharma raises $84m

    They are now developing a pipeline of first-in-class DDR therapies targeting novel DNA repair targets like Pol θ, in tumours where DNA damage response factors have been lost or ... The company says it aims to initiate a first-in-human clinical study of

  • FDA delays verdict on Roche's MS drug Ocrevus FDA delays verdict on Roche's MS drug Ocrevus

    Ocrevus is the first investigational medicine with the potential to treat both forms, outperforming Merck KGaA's Rebif (interferon beta-1a) in the two relapsing multiple sclerosis phase III trials and ... Roche is now due to hear from the FDA by 28 March,

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Latest Intelligence

  • 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'

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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

    Zurich-based biotechnology company Inositec has appointed a new chief medical officer in the form of Dr Frits van Alphen. ... in the vascular calcification space and fine-tune our clinical strategy in view of first-in-human studies in 2019.”.

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Latest from PMHub

  • Packer Forbes News April 2016

    Hannah graduated with first class honours in Human Biology from the University of Birmingham. ... We have made our annual charity clothes donation in aid of Multiple Sclerosis Research.

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