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FDA

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

Gottlieb admonishes industry for clinical trial failings

Gottlieb admonishes industry for clinical trial failings

That is according to outgoing FDA commissioner Scott Gottlieb, who says in a statement that there is “a continued reluctance to adopt innovative approaches among sponsors and clinical research organisations.”. ... The comments comes as the FDA has

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  • CHMP recommends new Keytruda dosing schedule CHMP recommends new Keytruda dosing schedule

    Newcomer Libtayo from Sanofi and Regeneron recently received an FDA approval for use in metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery ... It made history by becoming the first

  • Liver specialist Genfit files $120m IPO on Nasdaq Liver specialist Genfit files $120m IPO on Nasdaq

    It is expecting to have interim results from the pivotal trial before the end of the year and, if positive, thinks these will support accelerated approvals from the FDA and EMA. ... Shortly afterwards, Intercept Pharma reported somewhat mixed phase 3

  • AZ to address Imfinzi setback, but sees potential with Tagrisso AZ to address Imfinzi setback, but sees potential with Tagrisso

    BMS ran into a hurdle with this combo earlier this year however, and pulled the marketing application in the US after the FDA requested for more information on TMB, PD-L1

  • NCI head Sharpless named as interim FDA chief NCI head Sharpless named as interim FDA chief

    Sharpless’ deep scientific background and expertise will make him a strong leader for FDA,” said Azar in a statement. ... Others mentioned in dispatches include FDA principal deputy commissioner Amy Abernethy, US assistant secretary for health Brett

  • Celgene’s Abraxane fails pancreatic cancer trial Celgene’s Abraxane fails pancreatic cancer trial

    It secured another this week when the FDA cleared the drug in combination with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) for triple-negative breast cancer – becoming the first immunotherapy regimen ... for a breast cancer indication – and in

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Latest Intelligence

  • Cell and gene therapy Cell and gene therapy

    Interest in cell and gene therapies is undeniable. In January, US FDA Commissioner Scott Gottlieb outlined policies designed to accommodate an anticipated surge in cell and gene therapy submissions.

  • 2019: CRISPR and therapeutic gene editing comes of age 2019: CRISPR and therapeutic gene editing comes of age

    The FDA placed the CTX001 programmed in beta thalassemia and a planned trial in sickle cell disease on a clinical hold shortly afterwards, but relaxed that last October. ... tested in gene therapies (and the technology which caused the FDA to raise

  • Immuno-oncology in 2019: the rapid evolution continues Immuno-oncology in 2019: the rapid evolution continues

    In December the FDA approved its use in combination with Avastin and chemotherapy in non-squamous NSCLC patients, based on results from the IMpower150 study. ... On 28 December, Keytruda gained FDA clearance for use in Merkel cell carcinoma.

  • Drug launches to watch in 2019 Drug launches to watch in 2019

    GW Pharma gained an historic approval for its drug Epidiolex from the FDA in June last year, becoming the first ever prescription medicine derived from cannabis. ... The product gained EMA approval in November and FDA approval on 26 December.

  • Launch trends 2019 Launch trends 2019

    2018 saw the FDA approve a record number of drugs, as well as an increasing number in orphan disease areas.

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