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Early Alzheimer’s disease treatment meets trial primary endpoints
Aducanumab, an Alzheimer's disease treatment, will be submitted as part of a Biologics License Application after meeting clinical trial primary endpoints.
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Data Analysis
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On the edge of glory: how close are we to fully automated continuous biopharma production?
We’re getting closer to something special with regard to how we manufacture biopharmaceuticals. Loe Cameron explores where the continuous bioprocessing journey could take us and what it might mean for medicine manufacturers worldwide.
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Imfinzi combination fails advanced lung cancer study
A late-stage clinical trial for Imfinzi and an experimental treatment has not extended the lives of patients with advanced non-small cell lung cancer.
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Application note: PharmaIntegrityTM – Cleanroom Data Management System
PharmaIntegrity™ is the definitive solution for managing the collection, analysis, and trending of environmental monitoring data, ensuring timely detection of problems in production, facilitating product release and reducing risks and costs associated with product loss and recalls.
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US and China should collaborate more to bring AI to healthcare
New article says that to take full advantage of deep-learning solutions in healthcare, the US and China should collaborate, not compete.
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Microrobots could be used to deliver drugs inside the body
Scientists have developed microrobots that can deliver medication to specific spots inside the body while being controlled from outside the patient.
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Case study: Merck Leverages Data and Analytics to Support New Continuous Drug Manufacturing Processes
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.
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FDA rejects AstraZeneca’s Farxiga treatment
AstraZeneca has been issued with a complete response letter for Farxiga by the FDA meaning that it has rejected the treatment.
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Clinical trial sponsors called to publish results on EU database
All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.
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Guide to Informatics & Data Integrity
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.
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ACD/Labs: empowering data-driven decisions
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…
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European Pharmaceutical Review Issue 3 2019
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.
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Recommendations released to help the EU combat high drug prices
New briefing documents provide policy recommendations to help the EU tackle high medicines prices brought about by market monopolies.
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LABVOLUTION: Paving the way for the lab of the future
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.
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Pharmaceutical cleanroom monitoring software solution
Particle Measuring Systems releases the new Pharmaceutical Net® Pro Environmental Monitoring Software for FacilityPro® Environmental Monitoring Systems.
