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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, August 2021
The EMA's drug safety committee (PRAC) recommends updating risks of Janssen COVID-19 Vaccine, though the benefit-risk balance remains unchanged.
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Libtayo® with chemotherapy trial stopped early due to success
Phase III trial of Libtayo® (cemiplimab) combined with chemotherapy stops early due to significant improvement in overall survival in lung cancer patients.
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Biogen announces results from Phase IIIb NOVA study for MS
Results from the NOVA study show every six-week dosing with natalizumab is as effective as every four-week in relapsing-remitting MS.
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FDA approves emergency use of REGEN-COVTM for COVID-19 prevention
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
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Genomic sequencing is a potential key to precision medicine for cancer
A new US study demonstrated that comprehensive genomic sequencing is crucial for the development of precision medicine for cancer patients.
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2021 a pivotal year for personalised neoantigens, says GlobalData
With multiple catalysts coming up in late 2021, GlobalData reports a boom in the field of personalised neoantigen immuno-oncology therapeutics.
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AI and big data will continue to disrupt pharma sector, says survey
A GlobalData report has revealed the extent to which companies will be using AI and big data in drug discovery and development processes.
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Revised general chapter on chemometric methods available for comment
The revised general chapter 5.21 has been published in Pharmeuropa 33.3, the European Pharmacopoeia online forum, for public comment.
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Using software to improve data management and output in pharma development
The COVID-19 pandemic has exposed various issues with the software and data processes employed in the pharmaceutical industry and spurred rapid digital transformation at a rate never before seen in the sector. In this article, Jordan Stobaugh, Principal Research Scientist at AbbVie, discusses how software can improve data management and…
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How COVID-19 has accelerated digital transformation and how laboratory orchestration platforms are changing the landscape
Thermo Fisher is ready to partner with your global team to help you meet your business goals and get life transforming treatments onto the market as quickly and safely as possible.
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Application note: Software that makes data integrity compliance visible
Read this application note to discover the software that makes data integrity compliance visible: Shimadzu LabSolutions database (DB) or client/server software (CS).
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Guide to Data Integrity
Welcome to European Pharmaceutical Review’s Guide to Data Integrity. In this edition, Ian Harrow and Thomas Liener, Consultant Project Managers at The Pistoia Alliance, explain the importance of the FAIR data principles; and Charles River Laboratories and Thermo Fisher Scientific showcase their unique data integrity services and discuss how they…
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Evolving your adverse event monitoring strategy for the post-COVID data influx
Marketing authorisation holders are increasingly challenged to identify all potential adverse events (AEs) and proactively address them with each new product that comes to market. In this article, Alison Sloane, General Manager of Vigilance Detect at IQVIA, discusses how adopting technology can not only streamline pharmacovigilance processes, but also address…
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New group to tackle data governance and guide digital transformation in pharma
The Pistoia Alliance's Data Governance Community of Interest will develop best practices and advance digital transformation in the pharma/life sciences industry.
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The big debate. Beyond the data and document distinction: how to transform life sciences experiences via improved information flow
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…
