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Pfizer and BioNTech seek FDA EUA for Omicron-based Covid-19 vaccine

Pharmaceutical Technology

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted 1-adapted vaccine. 5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 5 and the wild-type viral strain.

FDA 52
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Less Is More—A Sharper Focus on Patient Needs Improves Adherence

PM360

1 In addition, of patients who began therapy, more than 70% were no longer on their prescribed medication after 12 months. 1 Patients may discontinue if they cannot afford their out-of-pocket costs even with insurance coverage due to side effects or lack of perceived need for the medication itself. References: 1. 2020 to Oct.

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Is localisation the answer for pharmaceutical supply chain resilience?

European Pharmaceutical Review

We have reported several times on supply chain resilience since the start of the COVID-19 pandemic, 1-3 as the world experienced unprecedented lockdowns and supply disruptions, with interruptions to manufacturing as well as both air transportation and shipping routes. Keeping the equipment in the spoke sites to a minimum can also reduce cost.

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Achieving scale up success under economic uncertainty

European Pharmaceutical Review

1 We can only learn from the past and try not to repeat history. This starts with a sound strategy, attracting top talent, and agile decision-making. To stay ahead of potential pitfalls and unexpected challenges, companies should find a CDMO that prioritises transparency, agility, and trust.

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Endotoxin testing: the international regulatory landscape

European Pharmaceutical Review

in the monographs for Water for Injection (0169) and Purified Water (0008) on 1 April 2024. on 1 January 2024. Pharma Horizons: Environmental Monitoring About the authors Evelyn Der joined Genentech, a member of the Roche Group, in 1999 and currently is in the Analytical Sciences chapter of Roche.

Ethics 89
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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

The original iteration of ISPE GAMP 5 was released in 2008 arriving in the nascent stages of what has become the cloud revolution and certainly before the widespread adoption of agile development methodologies, meaningful augmented reality, machine learning and artificial intelligence use cases in the life sciences industry. FDA, 2022. .

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Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

1 In terms of efficiency, the ability to execute identification testing at point of receipt in the warehouse is preferred to the traditional approach of (i) sampling the material received, (ii) sending the samples to the lab for testing and (iii) quarantining the material until laboratory confirmation is received.