All articles by Rebecca Harding – Page 2
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Industry newsICH releases M15 guideline on model-informed drug development
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M15 Expert Working Group has developed a draft guideline on model-informed drug development (MIDD) and is now under public consultation.
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Industry newsEC announces evaluation of medical device and IVD regulations
The European Commission (EC) has announced an evaluation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
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Industry newsUse of new EMA platform for monitoring medicine shortages to become mandatory
The European Medicines Agency (EMA) has launched the European Shortages Monitoring Platform (ESMP), aimed at preventing and managing shortages of centrally authorised products (CAPs).
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Industry newsGSK Blenrep trial shows ‘significant overall survival benefit’of myeloma treatment
According to a report by GSK, a recent clinical trial has revealed that Blenrep can reduce the risk of death by 42% in multiple myeloma after relapse.
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Industry newsFDA proposes to remove oral phenylephrine in selected drugs
The US Food and Drug Administration (FDA) has released an update proposing the removal of oral phenylephrine as the active ingredient in drugs for treating nasal congestion.
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