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FDA

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

FDA takes aim at pharma’s biosimilar-delaying tactics

FDA takes aim at pharma’s biosimilar-delaying tactics

Ever-rising cost of insulins also to be targeted. FDA Commissioner Scott Gottlieb has repeated a warning that the agency will crack down on delaying tactics deployed by pharma to ... He has spoken out repeatedly against anti-competitive tactics and

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  • FDA clears Sandoz and Pear’s Opioid Use Disorder app FDA clears Sandoz and Pear’s Opioid Use Disorder app

    The app incorporates CBT to improve high relapse rates. The FDA has approved the use of a mobile phone app to help those with Opioid Use Disorder (OUD), a follow up ... McCann added: “This ground breaking decision by the FDA ushers in a new standard

  • Axovant drops last ‘legacy’ drug to focus on gene therapies Axovant drops last ‘legacy’ drug to focus on gene therapies

    After recent meeting with the FDA, the firm as said it will be able to draw on earlier clinical data with a first-generation version of the gene therapy which was

  • eConsent: Busting regulatory myths eConsent: Busting regulatory myths

    The US Food and Drug Administration (FDA), The European Medicines Agency (EMA), The Office of the Human Research Protection Program (OHRP), The Health Insurance Portability and Accountability Act of 1996 (HIPAA) ... In 2016, the FDA released its draft

  • Amgen’s BCMA drug on course to challenge CAR-Ts in myeloma Amgen’s BCMA drug on course to challenge CAR-Ts in myeloma

    Amgen also revealed that it has fast-track status for AMG 420 from the FDA, and intends to accelerate enrolment into an expanded study population that will include patients in earlier

  • FDA fast tracks Novartis’ SMA gene therapy FDA fast tracks Novartis’ SMA gene therapy

    Novartis has announced that the FDA is to fast-track its investigational gene therapy AVXS-101 candidate for spinal muscular atrophy (SMA) type 1, meaning it could be approved as early ... Its president David Lennon, said: “This important step by the

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