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Food and Drug Administration

This page shows the latest Food and Drug Administration news and features for those working in and with pharma, biotech and healthcare.

Novartis announces positive phase 3 trial results for advanced oesophageal cancer

Novartis announces positive phase 3 trial results for advanced oesophageal cancer

The treatment is currently under review by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for relapsed oesophageal cancer, with the FDA due to deliver its ... The EMA is also reviewing the drug for advanced or

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  • Listen, learn and lift off Listen, learn and lift off

    remains. Yet, anxiety swirls around strategising commercial drug launches through harnessing patient insights and data, identifying client segments, timings and the new generation of omnichannel options. ... The US Food and Drug Administration (FDA) and

  • Expanding clinical trial access: a global imperative requiring local focus Expanding clinical trial access: a global imperative requiring local focus

    We have particularly focused efforts on meeting the Food and Drug Administration’s expectations (see guidance for reflecting the demographics of treatment populations and collecting race and ethnicity data in trials). ... trial design and planning and

  • How early-stage clinical research is facilitating the new wave of personalised medicines How early-stage clinical research is facilitating the new wave of personalised medicines

    The first ever siRNA therapy was only approved by the US Food and Drug Administration (FDA) in 2018 – Patisiran for the treatment of the nerve disease (polyneuropathy) – and two further siRNA ... Delivering trials directly to the target population

  • Diversity and inclusion in clinical trials Diversity and inclusion in clinical trials

    consideration diverse populations to better understand the benefits and associated risks across all groups. ... Regulation providing the framework for the future. In November 2020, the US Food and Drug Administration (FDA) issued new guidance to provide

  • Piloting a route to the biosimilars opportunities in Europe Piloting a route to the biosimilars opportunities in Europe

    In addition, national drug authorities across Europe, as well as the Heads of Medicines Agencies (CMDh), have been making similar efforts to provide access to biosimilars. ... The US Food and Drug Administration (FDA) is catching up quickly too,

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Latest appointments

  • Parexel expands global regulatory services team Parexel expands global regulatory services team

    Robert Iser joins Parexel as its vice president of regulatory consulting service from his post as director of the Food and Drug Administration’s ( FDA) Office of Process and Facilities. ... He brings a decade of experience leading global oncology and

  • Silence Therapeutics appoints Dr Annalisa Jenkins as non-executive chair Silence Therapeutics appoints Dr Annalisa Jenkins as non-executive chair

    forchief executive officer, Silence Therapeutics, said: “Annalisa’s extensive and broad experience in all aspects of biotechnology, drug development and commercialisation will prove to be invaluable. ... Dr Jenkins is also a committee member of the

  • AZ and Medimmune bolsters immuno-oncology leadership AZ and Medimmune bolsters immuno-oncology leadership

    patients. He most recently served the US Food and Drug Administration (FDA) as its director, division of oncology products in the office of haematology oncology products since 2015 and also had ... Prior to joining MedImmune, he served as a professor of

  • Constellation Pharmaceuticals strengthens management team Constellation Pharmaceuticals strengthens management team

    Prior to his time at Puma, Senderowicz held several roles for the life sciences sector including team leader at the US Food and Drug Administration (FDA), vice president, global regulatory oncology ... His background in drug development and the

  • Greenleaf Health appoints drug and biological products principal Greenleaf Health appoints drug and biological products principal

    Dr John Jenkins joins the FDA regulatory consulting firm. Washington, US-based Greenleaf Health has appointed Dr John Jenkins as principal for drug and biological products. ... Dr Jenkins brings over 25 years of experience from the US Food and Drug

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