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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 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,

Latest news

  • EU proposes reforms to make first-in-human trials safer EU proposes reforms to make first-in-human trials safer

    EU proposes reforms to make first-in-human trials safer. New guideline revision paper “ takes into account lessons learnt” from fatal Bial trial. ... Guidance on the way first-in-human (FIH) trials should be conducted and managed needs to be updated

  • Gilead gets EU nod for TAF-based triple therapy for HIV Gilead gets EU nod for TAF-based triple therapy for HIV

    In the first 18 weeks from launch in the US last November, Genvoya's uptake is outpacing Gilead's other products and is its most successful launch since it rolled out ... Integrase inhibitor. Gilead also reported preliminary, first-in-human data from a

  • Tantalising data for Baxter spin-off's haemophilia therapy Tantalising data for Baxter spin-off's haemophilia therapy

    However, the first-in-human dosing study for the therapy also revealed evidence of an immune response to the treatment that could make dosing critical and potentially limit its long-term ... use. The interim data from the ongoing phase I/II trial

  • MSF disputes Tufts’ estimates on cost of drug development MSF disputes Tufts’ estimates on cost of drug development

    failure rates for drugs tested in human subjects. ... The Tuft CSDD analysis was based on information provided by 10 pharmaceutical companies on 106 randomly selected drugs that were first tested in human subjects anywhere in the world between 1995

  • Translational pharmacology: the key to ensuring safe and effective dosing Translational pharmacology: the key to ensuring safe and effective dosing

    The results of these studies are used to demonstrate proof-of-concept for the proposed indication and to support safety for first-in-human administration in a phase 1 clinical trial. ... Results of the preclinical pharmacology-toxicology programme are

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Latest Intelligence

  • 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

  • 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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