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The pharmaceutical industry faces mounting pressure to modernise its testing methods, driven by concerns over animal welfare, sustainability, and the need for more reliable results. Following a recent webinar, Fujifilm Wako discusses its Pyrostar™ Neo+ reagent and reveals how recombinant technology is transforming endotoxin testing while addressing evolving industry demands.
The US drug agency’s authorisation provides hereditary angioedema (HAE) patients with the first new on-demand treatment in over ten years.
2 July 2025 | By MasterControl
This webinar explores innovative, purpose-built AI solutions that elevate compliance and efficiency in quality and manufacturing operations.
The EU authorisation offers a new treatment option for acromegaly, providing effective disease control and enabling convenient self-administration.
Cell therapy expert Lindsay Davies, PhD, FHEA, discusses the key considerations for moving the needle to broader adoption of CGTs in Europe.
EPR Issue 2 includes articles on the impact of tariffs on the pharmaceutical supply chain, advances in bioprocessing, manufacturing and more.
The new UK strategy represents a milestone for enhancing international competitiveness and puts into motion the upcoming Life Sciences Sector Plan.
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.
The committee’s final draft guidance cited high-cost as a key reason for its negative opinion of the Alzheimer’s drugs, developed by Biogen and Eisai.
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.
The UK medicine agency's most recent recalls of this class have been due to packaging and potential contamination issues.
The FDA’s authorisation helps to address the “significant” remaining need for acute hepatitis C treatments, according to AbbVie.
Stefan Braam, Chief Technology Officer, Cellistic, explores the manufacturing and regulatory challenges of scalable, off-the-shelf iPSC-NK cell therapies.
MHRA’s publication is intended to support European developers of phage-based medicinal products to effectively navigate related regulations.
The new EU rules for medicines aims to strengthen EU pharmaceutical competitiveness and reduce the regulatory burden.
