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FDA approves remdesivir for treatment of COVID-19
The FDA has given marketing authorisation for Veklury (remdesivir) to treat COVID-19 patients requiring hospitalisation.
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Regulation & Legislation
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On-demand webinar: Extractables profiles for chromatography resins
Extractables studies for chromatography resins based on the adapted requirements of the USP support risk evaluation for chromatography steps.
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On-demand webinar: BioPhorum raw materials risk assessments
Introduction to BioPhorum (BPOG) raw materials risk assessments tool and an overview on risk assessment regulations for raw materials.
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EMA recommends 10 medicines for approval in October meeting
Ten medicines have been recommended for marketing authorisation and 10 extensions of indication have been suggested by the EMA.
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UK to establish human challenge studies for COVID-19 vaccines
The UK government hopes to expedite the development of a COVID-19 vaccine by investing £33.6 million in the first phase of establishing human challenge trials.
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Manufacturing, Packaging & Logistics In-Depth Focus 2020
In this in-depth focus explore the implications of Trump's 'Buy American’ order for drug manufacturers, how researchers step-up metformin production from lab to industry scale and a discussion on how advanced planning could enable pharmaceutical production to be scaled up.
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Study suggests dolutegravir is the optimal first-line HIV medication
Researchers comparing dolutegravir to efavirenz suggest dolutegravir increases viral suppression and has similar rates of adverse events.
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The FDA requires changes to NSAID labelling
The FDA is requiring that the prescribing information for nonsteroidal anti-inflammatory drugs (NSAIDs) include warnings about potential foetal kidney problems if taken by women over 20 weeks pregnant.
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Formulation, Development & Delivery In-Depth Focus 2020
In this in-depth focus experts provide guidance on how to select starting materials for API's and discuss how to specify exipients to reduce downstream regulatory burdens.
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European Pharmaceutical Review Issue 5 2020
In this issue you can find articles discussing the supply chain implications of Trump's 'Buy American' order, guidance on how to identify and justify starting materials for regulatory approval by both the EMA and FDA, as well as some of the latest developments in oral biologic drug delivery techniques. Also…
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MHRA joins international regulatory consortium
By joining the Access Consortium, the MHRA will work together with agencies from Australia, Canada, Singapore and Switzerland to expedite therapeutic product approvals.
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US FDA approves the first Ebola virus treatment – Inmazeb
The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) for the treatment of Zaire ebolavirus infection in adults and children.
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Speeding processes and enhancing compliance with pharmacovigilance automation
Dr John Price explains how life sciences companies are making progress with pharmacovigilance automation and how a new study of pharmaceutical organisations has uncovered potential for improvement in the capture of adverse event data.
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NICE to simplify how medicines are selected for evaluation
NICE has launched a public consultation for suggestions on updating how it selects the topics to develop guidance on, to improve medicine evaluations.
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Reality check: is robotic process automation a panacea for transforming regulatory affairs?
Regulatory operations are burdened by resource-draining document and data processing tasks, but is robotic process automation the definitive solution? If not, where does it have greatest application and appeal – and how can life sciences firms exploit the full benefits? Agnes Cwienczek scrutinises the technology’s potential.
