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In light of the increased popularity of cannabis vaping in the United States, new regulations in the state of Colorado assert the need to test for heavy metal contaminants. Here, Robert Thomas explains the reasons for this pressing need and the challenges it presents.
In this article, Charles River Associates (CRA) delves into why traditional vaccine procurement schemes are not fit for purpose during the pandemic and how both governments and manufacturers must adapt to manage the greater level of risk associated with pandemic vaccine development and distribution.
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
The EMA’s drug safety committee has concluded that the Janssen COVID-19 Vaccine is safe for continued use, so Johnson & Johnson will resume shipments to the EU.
The course of drug development rarely does run smooth. Here, Dave Elder considers how sourcing key excipients impacts the process, highlighting potential consequences of a dual sourcing strategy and suggesting how to approach problems of inter-supplier variability.
Enhertu® (trastuzumab deruxtecan) has been made available to allow for more safety and efficacy data to be collected prior to the NICE’s decision about its routine use on the NHS.
The Emergency Use Authorization (EUA) was revoked after data suggested that, in the US, the prevalence of variants likely to be resistant to the monoclonal antibody bamlanivimab alone is increasing.
The new chapter, to be released in May, highlights the benefits of water activity measurement, as well as potential applications and best practices for use in pharmaceutical manufacturing.
European Pharmaceutical Review's latest journal features articles discussing the challenges and potential of antibody-drug conjugates, innovations in cleanroom infrastructure and why we need to test for heavy metal contaminants in cannabis vaping aerosols. Also in the issue, an exploration of how risk-sharing strategies could help expedite access to COVID-19 vaccines,…
Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
The FDA and CDC have decided to temporarily suspend use of Janssen’s single dose vaccine while reports of rare and severe blood clots are investigated.
12 April 2021 | By Charles River Laboratories
Watch this on-demand webinar with Jordi Iglesias to learn how you can improve the data integrity of your microbiological QC assays.
The observatory will collate drug safety data, analyses and decisions into a single source to help pharma identify regional differences in decision-making.
The life sciences industry may have been slower than other markets to appreciate the benefits of holistic data and document management, but that is changing rapidly now. Here, life sciences data and content management visionaries Steve Gens of Gens & Associates, Remco Munnik of Iperion and James Kelleher of Generis…
The combination was approved on Phase III trial results which show it doubled progression-free survival and reduced risk of death by 40 percent, compared to standard of care.
