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Case study: Fully automated packaging line with track and trace solution
Read the success story of a Polish pharma manufacturer that ensured its production with a fully automated packaging line with track and trace solution.
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Regulation & Legislation
news
EMA and ECDC to collaborate on post-marketing monitoring of COVID-19 vaccines
Under a new initiative, the EMA will monitor on the safety of marketed COVID-19 vaccines while the ECDC monitors their effectiveness in Europe.
news
Highlights of the EMA’s human medicine committee meeting, April 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for approval and nine indication extensions.
news
Further woes for Emergent’s Bayview vaccine production facility
An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.
news
NICE recommends ravulizumab for treatment of a rare blood disorder
On the NICE’s recommendation, ravulizumab will be made available to hundreds of patients with paroxysmal nocturnal haemoglobinuria on the UK’s NHS.
news
FDA approves Jemperli for advanced endometrial cancer
Jemperli (dostarlimab) was granted accelerated approval after 42.3 percent recurrent or advanced endometrial cancer patients with deficient mismatch repair responded in a trial.
video
Discussing developments in RMM with Dr Tim Sandle, Bio Products Laboratory
In this video, Dr Tim Sandle explains how COVID-19 has impacted the application of rapid microbial methods (RMM) and much more...
article
Balancing regulations for weighing in a GMP quality control laboratory
The importance of analytical balances in laboratory operations demands that they be fit for purpose over the operating range and acceptance criteria specified in the laboratory user requirements specification. In this article, Bob McDowall, Director of R D McDowall Limited, discusses the regulatory requirements for analytical balances operating in GMP…
news
EMA board confirms the EU clinical trial portal and database is fit for purpose
The adoption of the 2014 Clinical Trial Regulation moves one step closer as the EMA confirms a key aspect, the EU trials database and portal, is on track for implementation.
article
Measurement of heavy metals in cannabis vaping aerosols: a practical assessment
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.
news
FDA halts COVID-19 vaccine production at Emergent facility
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
article
Sourcing of key excipients
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.
article
How to overcome barriers in the adoption of microbiome-based therapies
This article from the global consulting firm Charles River Associates (CRA) describes how manufacturers must address and overcome three key barriers hindering progress in the microbiome sector and the optimal strategies needed to demonstrate the value of microbiome-based therapies in successful commercialisation.
news
Enhertu® made available to breast cancer patients on UK’s Cancer Drugs Fund
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.
news
FDA revokes bamlanivimab Emergency Use Authorization
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.
