news
EMA recommends GSK’s Xevudy for the treatment of COVID-19
The EMA has recommended granting marketing authorisation for the use of Xevudy (sotrovimab) to treat COVID-19 in adults and adolescents.
List view / Grid view
Regulation & Legislation
article
Many hands make light work: why the new Bespoke Gene Therapy Consortium is a godsend for ambitious biopharma teams
In late October, we learned that an exciting and ambitious new entity – the Bespoke Gene Therapy Consortium (BGTC) – had come into being in the US, designed to encourage the delivery of more gene therapies for rare diseases. The consortium is an interesting construct, headed and funded by the…
whitepaper
Whitepaper: CMC regulatory landscape, cell and gene therapy products
This whitepaper gives an understanding of the evolving regulatory guidelines for cell and gene therapies, in order to bring them to market faster.
whitepaper
Whitepaper: Aggregation – the next logical step
Discover why pharmaceutical companies should consider aggregation as the next step towards supply chain drug traceability.
news
Pfizer’s Paxlovid™ can be used for the treatment of COVID-19, says EMA
New European Medicines Agency advice states Paxlovid™ can be used to treat those at high risk of developing severe COVID-19 symptoms.
news
ABPI publishes new roadmap to aid in ATMP development
The roadmap clarifies the processes to develop advanced therapy medicinal products (ATMPs), providing guidance on key considerations.
whitepaper
Case study: GC-MS for cGMP nitrosamine testing
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
whitepaper
Whitepaper: The new age digital contract research organisations
The ideal CRO digital platform offers an opportunity to un-burden bureaucracy and drive data capture and integrity straight into the digital eco-system allowing earlier intervention.
news
UK regulator publishes guidance on use of real-world data to support clinical trials
Two new guidance documents, the first in a series to published by the MHRA, outline considerations when planning a randomised clinical trial using real-world data.
article
Future proofing risk assessment: preventing the next nitrosamine incident
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
whitepaper
Application note: Setup and transfer of a gradient HILIC method
A fast and reproducible gradient HILIC method was set up for the impurity analysis of the hydrophilic temozolomide.
news
EMA launches the Regulatory Science Research Needs initiative
The European Medicines Agency (EMA) has issued a list of about 100 regulatory science topics that need further research to close gaps and improve medicine development.
whitepaper
Technical bulletin: Nitrosamine control: understanding the new FDA and EMA regulations
This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.
whitepaper
Whitepaper: Sterile formulation strategies to shorten timelines
This whitepaper reveals strategies to create simple, stable formulations for your sterile injectable, a solid foundation for your product’s lifecycle.
whitepaper
Case study: Results from bridging data management gaps
How CMC software helped a major pharmaceutical company improve process development and regulatory submissions.
