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Over the past couple of years, the European Medicines Agency and US Food and Drug Administration have given approvals to a handful of pharmaceutical companies to manufacture drug products using continuous manufacturing processes.
AstraZeneca has been issued with a complete response letter for Farxiga by the FDA meaning that it has rejected the treatment.
All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.
In this edition, two companies showcase their services and highlight how they stand out from the crowd. The exponential speed of the information technology evolution is rapidly being accepted and integrated into our everyday life, yet it remains a challenge in the laboratory.
ACD/Labs helps scientific R&D organisations assemble digitised analytical, structural and molecular information for effective decision-making, problem solving and product lifecycle control by their scientists. Their enterprise technologies enable automation of molecular characterisation and product development, and facilitate chemically intelligent knowledge management, data analytics and collaboration – both within organisations and…
In this issue we explore reasons behind critical key drug shortages in the EU, whether viability methods effectively detect all viable organisms and how companies can future-proof their digital technologies ahead of Brexit. Also included are articles on higher order protein structure, FMD compliance and Raman spectroscopy.
New briefing documents provide policy recommendations to help the EU tackle high medicines prices brought about by market monopolies.
The connected laboratory is now the only way forward, as the three days of the LABVOLUTION show have clearly demonstrated. Decision-makers, product developers and users from the various segments of the laboratory industry gathered in Hannover for a close look at the latest developments and future trends.
Particle Measuring Systems releases the new Pharmaceutical Net® Pro Environmental Monitoring Software for FacilityPro® Environmental Monitoring Systems.
Katalyst D2D is a new software application from ACD/Labs that makes the planning, execution and analysis of high-throughput, parallel experiments easier than ever before. Katalyst is a web-based digital environment that integrates with existing informatics systems, lab automation hardware, analytical instrumentation and automated execution systems for an efficient, streamlined workflow.
With international regulatory agencies calling for pharma companies to properly manage data integrity issues to ensure GMP compliance, Abbott Informatics demonstrates how their STARLIMS solutions can provide support for numerous systems.
There are many business challenges to developing a biologics drug, one of which is effective data management. In this article, Unjulie Bhanot focuses on efficient data management policies and systems, and how they could improve biologics product development processes.
Leading international partner to the biopharmaceutical industry Sartorius Stedim Biotech (SSB) has today announced that the new SIMCA® 16 software for multivariate data analytics is available from its subsidiary Sartorius Stedim Data Analytics.
A filter has been designed to create more exact measurements early in the drug development stage and help move a drug to clinical trials faster.
A new study has found that prices for brand-name prescription drugs averaged 3.2 to 4.1 times higher in the US compared with other countries.
