news
FDA approves first-of-a-kind oral therapy for rare disease
The US drug agency’s authorisation provides hereditary angioedema (HAE) patients with the first new on-demand treatment in over ten years.
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Regs & Legs
webinar
Harnessing AI to transform quality and manufacturing in life sciences
2 July 2025 | By MasterControl
This webinar explores innovative, purpose-built AI solutions that elevate compliance and efficiency in quality and manufacturing operations.
news
Novel pre-filled autoinjector receives EU approval
The EU authorisation offers a new treatment option for acromegaly, providing effective disease control and enabling convenient self-administration.
article
Alliance for impact – advancing CGT development in Europe
Cell therapy expert Lindsay Davies, PhD, FHEA, discusses the key considerations for moving the needle to broader adoption of CGTs in Europe.
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European Pharmaceutical Review Issue 2 2025
EPR Issue 2 includes articles on the impact of tariffs on the pharmaceutical supply chain, advances in bioprocessing, manufacturing and more.
news
Life sciences a “priority sector” in UK Industrial Strategy
The new UK strategy represents a milestone for enhancing international competitiveness and puts into motion the upcoming Life Sciences Sector Plan.
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Regulatory shift signals potential change for future CGT sector
The cell and gene therapy (CGT) sector must maintain its scientific rigor despite recent changes to US policy and market conditions, says key industry body.
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NICE concludes decision for two Alzheimer’s treatments
The committee’s final draft guidance cited high-cost as a key reason for its negative opinion of the Alzheimer’s drugs, developed by Biogen and Eisai.
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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper
Here, Vladimir Murovec, Counsel, Osborne Clarke, discusses the European Medicines Agency (EMA)’s latest draft reflection paper and its scientific rationale, regulatory implications and potential impact on biosimilar drug development and manufacturing in the EU.
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MHRA Class 2 medicine recalls – May/June 2025
The UK medicine agency's most recent recalls of this class have been due to packaging and potential contamination issues.
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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.
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.
