New regulation strengthens role of EMA in EU crisis response
The regulation sees tools, structures and processes set up by EMA during the pandemic to accelerate clinical trial approval and regulatory assessments in the EU being formally recognised.
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The regulation sees tools, structures and processes set up by EMA during the pandemic to accelerate clinical trial approval and regulatory assessments in the EU being formally recognised.
The new North Carolinian site will increase parenteral and device manufacturing capacity and create 600 new jobs.
CME will support the delivery of automated just-in-time clinical supply, as one of the collaborators in the Medicines Manufacturing Innovation Centre Grand Challenge 2.
What are the top six challenges facing pharmaceutical and biopharmaceutical manufacturers in 2022? We spoke to representatives from four contract manufacturing and development organisations (CDMOs) – Samsung Biologics, Lonza, MedPharm and Genezen – to find out.
When the pandemic broke out in 2020, pharmaceutical supply chains showed signs of potential failure across the continent. Now, with COVID-19 cases rising once more, and an end to the problem not yet in sight, we discuss with Medicines for Europe how these supply chains are faring, almost two years…
We are experiencing a time of polarity in our healthcare systems with breakthrough treatment options developed, but access prohibited. Here, Catherine Owen, SVP of Major Markets at Bristol Myers Squibb, explains why, despite continued COVID-19 pressures, the time is ripe to rectify this situation.
Healthcare groups including the US Pharmacopeia and American Medical Association release advice for policymakers on addressing challenges in the US supply chain.
This journal features articles discussing what knowledge could help the industry to prevent the next nitrosamine-like contamination event, the key steps when validating analytical techniques for cell and gene therapies and how artificial intelligence is shaping microbiology. Also in this issue, using Raman spectroscopy and hyperspectral imaging to detect counterfeit…
With global supply chains under stress due the pandemic, European pharma companies are increasingly looking for alternative supply channels.
The Energize programme will allow 10 big pharma companies to engage with renewable energy suppliers and address their greenhouse gas emissions.
This application note discusses some of the critical issues users experience with endotoxin testing around accuracy, flexibility, sustainability and platform cost.
2021 Medicines for Europe-IGBA conference speakers assert that off-patent medicines will be crucial to rebuild healthcare post-COVID-19.
Regeneron announced a new US government agreement to purchase additional doses of REGEN-COV (casirivimab and imdevimab) antibody cocktail.
In this article, EPR's Hannah Balfour outlines six factors that could significantly challenge the generics and biosimilars market in the next decade.
BioNTech will evaluate mRNA vaccine manufacturing facilities in Rwanda and Senegal to support vaccine supply in African states.