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drug safety

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

Evenity back on track with FDA panel blessing in osteoporosis

Evenity back on track with FDA panel blessing in osteoporosis

While the FDA still has the final say on full approval, the bone-building drug seems to have finally shaken off the cardiovascular safety concerns that caused the agency to reject ... Importantly for Amgen, FDA briefing documents published ahead of the

Latest news

  • US government shutdown leaves FDA running on empty US government shutdown leaves FDA running on empty

    One action we’ll be taking is to re-allocate user fee money from certain pre-market drug review work to post-market drug safety surveillance,” he said. ... Those working in drug regulation are still able to tap into 2018’s user-fee pot, but others

  • Bayer preps filings for new prostate cancer drug Bayer preps filings for new prostate cancer drug

    It has picked up a fast-track designation for the drug from the FDA for non-metastatic CRPC. ... The new drug has a fairly benign safety profile, which is put down to the fact that it has minimal blood-brain barrier penetration and does not significantly

  • Alnylam seeks fast-track filing with biomarker data Alnylam seeks fast-track filing with biomarker data

    Early filing reflects FDA desire for faster approvals. Alnylam is set to file its next RNAi drug candidate givosiran with regulators after producing strong phase 3 data. ... The FDA will pay close attention to the drug’s safety and efficacy data, with

  • Shire’s bleeding disorder drug approved in Europe Shire’s bleeding disorder drug approved in Europe

    Administered as an injection, the drug is now the first and only recombinant von Willbrand Factor (rVWF) treatment approved in the EU that specifically treats the primary deficiency of VWF, one ... The European Regulator’s decision was based out data

  • Pfizer abandons antibody for Duchenne Pfizer abandons antibody for Duchenne

    The decision was not taken because of any safety issues with the drug, he stressed.

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Latest Intelligence

  • Five questions guiding the way to actual patient-centricity Five questions guiding the way to actual patient-centricity

    We also learned that patients’ trust, encouraged by a better comprehension of our work, has been correlated with better clinical outcomes and features, including drug adherence and reporting of safety concerns. ... 3 Are we ready to offer value (beyond

  • Behaviour change – a missing ingredient? Behaviour change – a missing ingredient?

    It already invests hugely in long-term development programmes to understand drug efficacy and safety; the step required to take the same long-term view on implementing behaviour change programmes is ... If behavioural aspects are investigated and

  • A new era of smart pharma A new era of smart pharma

    Blending Reportum with AI and Robotic tools affords pharma companies the opportunity to transform their end-to-end drug safety processes today. ... Medical adherence is being improved. Drug delivery technology has improved significantly in recent years.

  • Drug safety

  • The gold standard of scientific evidence The gold standard of scientific evidence

    Dr Basu supports using phase II clinical trials to determine drug safety and then replacing phase III clinical trials with only-in-research (OIR) labelling over a specified period (eg, two ... The FDA uses RWE to monitor drug safety as part of the

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