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The imperative of fridge-free vaccines

European Pharmaceutical Review

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient.

Vaccines 111
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Oxford Nanopore makes stellar debut on UK stock market

pharmaphorum

It also won a £113 million contract to provide rapid saliva-based COVID-19 testing services to the NHS, although that was ended early by the UK government in the summer as demand fell due to vaccinations. It may also use the cash injection for “in-licensing opportunities and potential acquisitions”, according to the document.

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Accommodating Multiple Modalities in the Same Facility

ISPE

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Complete Data Gathering. Outline Guiding and Segregation Principles.

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Why are Post-Approval Pregnancy Studies Post-Marking Requirements Rather Than Post-Marketing Commitments?

The FDA Law Blog

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

FDA 59
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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Published July 2014.

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Highlights from ESCMID Global 2024: AI, climate change and AMR

Hospital Pharmacy Europe

In 2014 and 2015 Professor Claverie’s team revived a 30,000-year-old virus, leading to media attention about so-called ‘zombie viruses’. Over 70 graphics, including alternatives to handshakes and explanations of mRNA vaccines, were then created and published online by The Spinoff, a New Zealand news outlet.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard. New Project: Evolutive Vaccines Facility for Sanofi.” www.boccard.com/evolutive-vaccines-facility-for-sanofi/ 42 Amgen.