List view / Grid view
Through the recent coronavirus crisis, the UK’s pharmaceutical sector has performed strongly and delivered innovation at a time when it was most needed. In this article, Dr Cheryl Teoh discusses how the industry has been set up for success.
NICE has recommended pembrolizumab for the treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).
The FDA has given marketing authorisation for Veklury (remdesivir) to treat COVID-19 patients requiring hospitalisation.
Extractables studies for chromatography resins based on the adapted requirements of the USP support risk evaluation for chromatography steps.
Introduction to BioPhorum (BPOG) raw materials risk assessments tool and an overview on risk assessment regulations for raw materials.
Ten medicines have been recommended for marketing authorisation and 10 extensions of indication have been suggested by the EMA.
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.
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.
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…
By joining the Access Consortium, the MHRA will work together with agencies from Australia, Canada, Singapore and Switzerland to expedite therapeutic product approvals.
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.
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.
NICE has launched a public consultation for suggestions on updating how it selects the topics to develop guidance on, to improve medicine evaluations.
The ABPI has found that the UK is leading the rest of Europe in early-stage clinical trials and makes suggestions on how the country can maintain this position.
EPR’s Hannah Balfour discusses some of the proposed COVID-19 vaccine distribution plans and how medicinal nationalism and supply deals could prevent “fair and equitable access” to COVID-19 vaccines.
