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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.

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Ph. Eur. adopts revised general monographs after adding paragraph on N-nitrosamines

European Pharmaceutical Review

Priorities for 2022-2025. These included 40 experts appointed by the EPC to join the newly created Working Party on mRNA vaccines , following a call for experts issued in the summer of 2022. Approval of the Guide on the declassification of documents pertaining to the work of the Ph. Appointment of 886 experts from Ph.

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UK adds £175m funding to clinical research recovery drive

pharmaphorum

Part of the plan includes a pledge to “streamline and strengthen the regulatory environment to ensure faster approval, set-up and delivery of studies,” according to the new document, which also points to increased investment in “digitally focused trials.” — NIHR Research (@NIHRresearch) June 30, 2022.

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COVID-19 has propelled the regulatory industry years ahead

pharmaphorum

The development of COVID-19 vaccines required levels of cooperation and pioneering science comparable to the Apollo space programme. Within 12 months of the outbreak, vaccines were being deployed to prevent severe infections, hospitalisation, and death. billion people have been fully vaccinated. COVID-19 vaccine tracker.

Vaccines 143
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European regulators revoke Covid-19 business continuity status

Pharmaceutical Technology

The business continuity plan was introduced in 2020 to allow European regulators to prioritise the assessment of Covid-19 therapeutics and vaccines while also handling other responsibilities. This meant Covid-19 medicines were prioritised when it came to different pharmacovigilance processes.

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Eric Halioua, President & CEO at PDC*line Pharma Shares Insights on the Results from P-I/II Trial with PDC*lung01

PharmaShots

PDC*line is much more potent than conventional dendritic cell-based vaccines in priming and boosting antitumor antigen-specific cytotoxic T-cells, including the T-cells specific for neoantigens, and is synergistic with checkpoint inhibitors. The technology can potentially be applied to any type of cancer.

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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.