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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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Regulation & Legislation
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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.
article
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.
news
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.
article
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.
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UK government inks deal for one million rapid COVID-19 diagnostic tests
The UK government will receive one million rapid COVID-19 antibody tests from Abingdon Health that provide results in 20 minutes.
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Eli Lilly provides update on COVID-19 antibody programmes
Eli Lilly has given an update on its neutralising antibody programmes, including its combination therapy in patients with COVID-19.
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FDA issues guidance for COVID-19 vaccine Emergency Use Authorizations
The FDA has released new guidance for sponsors regarding Emergency Use Authorizations for potential COVID-19 vaccines.
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How can virtual pharma companies de-risk new product launches?
Christoph Krähenbühl outlines five considerations for virtual pharmaceutical companies when launching a new drug product.
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CEPI establishes centralised COVID-19 vaccine evaluation network
Five labs have been selected by the Coalition for Epidemic Preparedness Innovations (CEPI) to act as a global network for the assessment of COVID-19 vaccine immunogenicity.
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Only Italy and India improved pharma economy in 2020, survey finds
Italy and India were found to be the only countries to have improved their pharma economy score in 2020, according to the CPhI Pharma Index.
webinar
Roadmap to compliance in environmental monitoring
5 October 2020 | By Merck KGaA
This on-demand webinar provides an overview of a holistic approach to achieve compliance with good manufacturing practice (GMP) requirements for environmental monitoring (EM) in aseptic manufacturing areas, such as ISO 5 cleanrooms in traditional setup, RABS or isolators.
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SMA drug Zolgensma® has “significant therapeutic benefit”, according to interim data
Treatment with Zolgensma® (onasemnogene abeparvovec) resulted in rapid and sustained improvement in motor function in spinal muscular atrophy (SMA) patients.
whitepaper
Whitepaper: How will COVID-19 accelerate vaccine development?
Watson-Marlow Fluid Technology Group discusses how the biopharma community is coming together to solve the global vaccine development challenge.
news
Could GDPR be impeding the global COVID-19 pandemic response?
Jasper Bovenberg and colleagues argue that the General Data Protection Regulation (GDPR) and associated guidelines has frustrated COVID-19 research, potentially harming global pandemic response efforts.
