Regulatory

CRISPR/Cas9 genetically engineered models: IP and licensing considerations

5 February 2021

This paid-for advertorial by Taconic Biosciences appeared in DDW Volume 22, Issue 1 – Winter 2020/21 In the following article, Dr. Caroline Horizny from Taconic Biosciences discusses the intellectual property landscape of CRISPR/Cas9-generated mouse models. The growing complexity of preclinical research for drug development has yielded an increase in the number of genetically engineered models […]

Medical cannabis and regulatory framework in Europe

3 February 2021

Medical cannabis is a growing market in Europe – but there is a lack of the usual regulatory framework intended to harmonise marketing of medicines and keep them safe. Arriello Director of Drug Safety Peter Kohut provides a guide to marketing cannabis products in the diverse European market. Medical cannabis has shown efficacy in trials […]

IDMP data standards – what next in 2021?

26 January 2021

Against the backdrop of COVID-19 disruption, there has been good progress made with European IDMP data standards. Remco Munnik of Iperion Life Sciences Consultancy looks back at the main IDMP developments in 2020 – and looks ahead to a future better supported by data standardisation. The COVID-19 pandemic has highlighted the potential for global data […]

Pharmacovigilance audits: implications of poor pass rates for drug developers

12 October 2020

Vanessa Fachada Oliveira, Pharmacovigilance Manager & EU QPPV at Arriello, discusses 10 common issues identified in risk-based audits, and pinpoints implications for drug developers as well as marketing authorisation holders (MAHs). In EU markets, pharmacovigilance (PV) provisions are closely monitored to ensure that patients can have maximum confidence in the safety of the products they take. […]

Automating regulatory data to drive discovery

25 September 2020

The multi-year process of drug discovery and development creates huge silos of data and information. Extracting and combining information can be a significant overhead, resulting in potential for delay and error. Iperion’s Duncan van Rijsbergen provides practical recommendations to help companies create high quality, consistent data that may be shared across systems. Pharmaceutical companies are […]

GSK receives first regulatory approval for Duvroq (daprodustat) in Japan

29 June 2020

29 June 2020 Image: Robina Weermeijer Approval marks a significant step in GSK’s global efforts to help patients with anaemia due to chronic kidney disease (CKD). GlaxoSmithKline has announced the approval of a Japanese New Drug Application (JNDA) by the Ministry of Health, Labour and Welfare for Duvroq (daprodustat) tablets, an oral hypoxia-inducible factor prolyl […]

Research highlights public desire for animal alternatives in research

24 June 2020 , Celean Camp (CEO) and Amy Beale (Scientific Liaison Officer) of FRAME (Fund for the Replacement of Animals in Medical Experiments)

24 June 2020 A survey has revealed that 93.4% of respondents think more needs to be done to replace and reduce the use of animals in testing and research. The study by independent scientific research charity FRAME (Fund for the Replacement of Animals in Medical Experiments), also found that over half think the use of animals in […]

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