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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.

Covidian selection

Covidian selection

Remember, for instance, that while the thalidomide tragedy changed our environment and selected for new routines in drug safety, those changes also spread to far greater regulation of manufacturing, marketing and

Latest news

  • FDA approves Roche’s Actemra COVID-19 trial FDA approves Roche’s Actemra COVID-19 trial

    Roche had announced its intent to collaborate on a trial evaluating the drug in COVID-19 patients with the US Biomedical Advanced Research and Development Authority (BARDA) earlier this month. ... limited published evidence on the safety or efficacy of

  • Trevena gets second go at FDA approval for pain drug Trevena gets second go at FDA approval for pain drug

    FDA sets review completion date of 7 August 2020. US biotech Trevena has resubmitted its lead drug oliceridine for moderate-to-severe pain in the US, 18 months after it was ... Trevena carried out a phase 1 trial to back up the safety of the drug on the

  • Esperion gets FDA thumbs up for cholesterol drug Nexletol Esperion gets FDA thumbs up for cholesterol drug Nexletol

    Big comeback after previous trial fail. US biopharma Esperion has secured US Food and Drug Administration (FDA) approval for its cholesterol-lowering drug Nexletol in a big comeback after a safety ... C-reactive protein” when added to statins, and also

  • Eisai agrees to pull obesity drug Belviq after safety alert Eisai agrees to pull obesity drug Belviq after safety alert

    The study was intended to check whether the drug was associated with any cardiovascular safety issues, but follow-up revealed “several different types of cancers occurring more frequently in the lorcaserin ... In 2010, the FDA rejected the first

  • Solid Bio axes staff by one-third as it clings to troubled DMD programme Solid Bio axes staff by one-third as it clings to troubled DMD programme

    The FDA halted the IGNITE DMD trial following a report of a serious adverse event (SAE) was deemed to be related to the drug. ... Sarepta Therapeutics was granted a  surprise FDA approval for its follow-up DMD drug Vyondys 53 – a drug which was also

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Latest Intelligence

  • Health trust in a COVID-19 world – a unique opportunity for pharma Health trust in a COVID-19 world – a unique opportunity for pharma

    Our team there hypothesised that this may be due to several highly publicised issues including Servier’s long-awaited trial over the safety of a weight loss drug, a large, monthslong ... hospital strike, increasing anti-vaccination sentiment and

  • Encouraging patient participation in real-world studies Encouraging patient participation in real-world studies

    rapidly becoming the latest frontier for life sciences companies in supporting regulatory filings and conducting drug safety surveillance.In a conversation with Bill Row, Bruce Capobianco and Maggie Adamski from ICON ... ways – from continuous

  • Rethinking trials: the pros and cons of protocol amendments Rethinking trials: the pros and cons of protocol amendments

    He added: “There are many factors that contribute to complexity, including more targeted and stratified patient populations, emerging safety issues, crowded drug classes and even the duration of time that multiple ... in addition to those resulting

  • Encouraging signs in biomarker R&D Encouraging signs in biomarker R&D

    Patient safety drive. For John Haanen, demands for safer immunotherapies are also a factor in the FDA’s call for biomarker and assay harmonisation. ... The potential downside, Magid Diefenbach said, is that immunotherapy firms may focus drug

  • Real-world studies Real-world studies

    myriad of information, from safety monitoring and drug utilisation studies of marketed products in the EU to routine safety monitoring of marketed products and filling evidentiary gaps for particular rare diseases ... trial recruitment, support

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