news
FDA grants expanded approval for hepatitis drug
The FDA’s authorisation helps to address the “significant” remaining need for acute hepatitis C treatments, according to AbbVie.
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Regulation & Legislation
article
Engineering scalable iPSC-NK therapies
Stefan Braam, Chief Technology Officer, Cellistic, explores the manufacturing and regulatory challenges of scalable, off-the-shelf iPSC-NK cell therapies.
news
MHRA issues first UK guidance on phage therapies
MHRA’s publication is intended to support European developers of phage-based medicinal products to effectively navigate related regulations.
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European Council announces progress on pharmaceutical package adoption
The new EU rules for medicines aims to strengthen EU pharmaceutical competitiveness and reduce the regulatory burden.
article
Pharma Horizons: environmental monitoring
This exclusive report addresses the key obstacles and innovations shaping pharmaceutical environmental monitoring, from QC and contamination control, to the impact of advanced technologies and regulatory changes. Discover practical solutions you can implement to drive progress for your organisation.
whitepaper
Strategies for endotoxin testing of RNA-LNP
Overcome matrix interferences in RNA–LNP endotoxin testing with LAL-based methods & recombinant factor C assays. Learn more in this whitepaper.
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CHMP meeting highlights – May 2025
The EMA’s committee has granted positive opinions for ten new treatments, including medicines for oncology indications and rare diseases.
news
FDA approval marks shift in diabetic retinopathy treatment
The ocular injection, now granted its third FDA approval, offers a more convenient treatment option for patients with vision loss.
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New real-world data guidance could accelerate drug approvals
The MHRA’s consultation, announced on International Clinical Trials Day, is intended to support creation of innovative UK trials.
article
UK immigration reform – implications for life sciences
This article offers key industry perspectives on the UK government’s recent immigration whitepaper and highlights the challenge of balancing economic growth and attracting skilled talent.
news
World-first approval supports AstraZeneca’s sustainability goals
Approval of the novel tool marks progress for both respiratory disease patients in the UK and reducing the global environmental impact of inhaled medicines.
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Tackling EU supply chain challenges while boosting innovation
Medicines for Europe calls for continued progress of pharmaceutical reforms such as the Critical Medicines Act, to support production of essential medicines in the region.
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Qualification of non-mutagenic impurities (NMIs)
In this article, Dave Elder reviews the European Medicines Agency (EMA)’s updated reflection paper on the qualification of non-mutagenic impurities (NMIs), which outlines alternative approaches to animal testing.
news
Landmark UK-India trade deal insufficient for life sciences, says industry body
The multi-billion-pound deal provides a boost to the UK’s economy, however it lacks provision to aid the country’s growth ambitions, states the ABPI.
news
Improving EU’s regulatory framework for enhanced pharma competitiveness
Despite its potential to become a more attractive destination for drug developers, new research insists the EU market makes improvements such as faster regulatory approvals and closer collaboration.
