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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.

Pfizer pauses enrolment for trial evaluating anti-BCMA bispecific antibody

Pfizer pauses enrolment for trial evaluating anti-BCMA bispecific antibody

Pfizer initiated the phase 2 study of elranatamab in February, with the aim of evaluating the safety and efficacy of the drug, administered subcutaneously, in patients with multiple myeloma that is ... The pharma giant is aiming to progress a phase 3

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  • The search for effective drug treatments for COVID-19 The search for effective drug treatments for COVID-19

    to find an effective drug treatment for patients and the journey of remdesivir that began a decade ago as part of Gilead’s emerging viruses programme. ... What were the trial results that led to this EUA? An EUA is a mechanism through which the Food

  • The US celebrates five years of biosimilars on the market – a look to the past, present and future The US celebrates five years of biosimilars on the market – a look to the past, present and future

    Representing $125.5bn in net drug spending, biologics accounted for less than 2% of all US prescriptions but more than one third of net drug spending in 2018. ... As of September 2020, the US Food and Drug Administration (FDA) has approved 28 biosimilars,

  • Emerging use cases of blockchain in healthcare and the life sciences

    One significant example of blockchain implementation in this area is the public-private partnership between the US Food and Drug Administration (FDA) and IBM. ... Clinical trials management. Clinical trials are highly complex endeavours, with a range of

  • Developing a COVID-19 vaccine Developing a COVID-19 vaccine

    The European Medicines Agency (EMA) and The US Food and Drug Administration (FDA) have both provided guidance on how to manage clinical trials during the COVID-19 pandemic. ... This includes people with underlying health conditions and those over the age

  • Alzheimer’s: the search for a cure Alzheimer’s: the search for a cure

    A lot is resting on the US Food and Drug Administration’s (FDA) interpretation of the data. ... The goal is to target distinct drivers of the disease, for example, by administering one drug to tamp down inflammation and another to address vascular

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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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