news
EMA’s PRAC June meeting highlights
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) finds the benefits of amfepramone medicines do not outweigh their risks and addressed possible links between COVID-19 vaccines and menstruation.
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Vaccines
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Article: Addressing the shortage of QPs in the pharma industry
How the pharma industry can tackle the shortage of QPs by Lynne Byers, Senior Director Pharma Consulting, NSF Health Sciences.
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Resources: Single use technologies – the ultimate future
Single use technologies is highly booming in biopharmaceutical sector due to its efficient use and benefits.
news
EMA’s first critical medicines list for COVID-19
The approved COVID-19 vaccines and treatments on the list will be monitored to prevent and mitigate the impact of shortages.
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Article: Outsourcing biologics: key considerations
PCI’s Tim Roberts discusses key factors when outsourcing the clinical and commercial supply of biologics, and what makes a strong CDMO partnership.
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Individualised mRNA vaccine shows promise in pancreatic cancer patients
Phase I study shows that mRNA-based individualised neoantigen specific immunotherapy (iNeST) vaccines can be used to stimulate T cells to recognise neoantigens in pancreatic cancer patients.
webinar
Digital versus digitised: common misconceptions about eConsent
6 June 2022 | By Medable
Learn about the common misconceptions surrounding eConsent, as well as the benefits they can realise through a digitally-enabled approach.
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ebook: Proactive clinical supply planning
The importance of thoroughly planned resupply strategies in maintaining clinical supply inventories as studies move into late phase.
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Article: Clinical and commercial outsourcing
The demand for biologics and high potent medicines is forcing the industry to consider alternatives, such as outsourcing and integrated solutions.
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GSK to acquire Affinivax for MAPS vaccine platform
GSK will pay up to $3.3 billion to acquire Affinivax, gaining access to its Multiple Antigen Presenting System (MAPS) technology and pneumococcal vaccine candidates.
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Bavarian Nordic signs supply contract for smallpox vaccine as monkeypox cases rise
The agreement between Bavarian Nordic and an undisclosed country aims to ensure sufficient supply of smallpox vaccine to meet the country’s requirements for vaccinating individuals at risk for monkeypox.
podcasts
EPR Podcast Episode 11 – Developing vaccine technologies – Giulia Giordano and Mark Doherty, GSK
Why is vaccine manufacturing becoming more biological? How could Generalized Modules for Membrane Antigens (GMMA) enhance vaccinology? What developments have there been in adjuvant systems? Discover all this and more in this podcast with GSK experts.
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Emergent destroyed almost 400mn COVID-19 vaccines due to quality issues, finds report
US Government investigation report suggests Emergent Biosolutions destroyed almost 400 million doses of COVID-19 vaccine and worked to conceal quality issues from the FDA.
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AstraZeneca acquires rights to develop mAbs against COVID-19
AstraZeneca has entered into a licence agreement with RQ Biotechnology Ltd for a portfolio of early-stage monoclonal antibodies (mAbs) targeted against SARS-CoV-2.
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ebook: Early drug development strategies for clinical success
Learn the benefits of collaboration between the pharmaceutical scientists and clinical supply services teams.
