EMA’s PRAC June meeting highlights
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) finds the benefits of amfepramone medicines do not outweigh their risks and addressed possible links between COVID-19 vaccines and menstruation.
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New guidance for membrane-based water for injection systems
The new Guide from ISPE presents best practices for design, operation, maintenance and quality of membrane-based water for injection (WFI) systems.
Digital growth focus of Sanofi’s new Digital Accelerator
Sanofi announces first Digital Accelerator to develop products and solutions that foster the use of digital, data and artificial intelligence.
Detecting and eradicating mycoplasmas in ATMP cell lines
Here, EPR summarises the key points of Tim Sandle’s recent review of mycoplasma risks, detection and eradication techniques for cell cultures.
New Berlin site to accelerate cell therapy innovation for BlueRock Therapeutics
BlueRock Therapeutics LP has established a new site for cell therapy innovation on Bayer’s campus in Berlin, Germany.
Fund to fast-track innovative drugs to NHS
The UK Government has announced the launch of the Innovative Medicines Fund to bring cutting-edge treatment more quickly to NHS patients.
HPLC market to grow by $1.26bn in five years
Increasing uses of high-performance liquid chromatography (HPLC) and rising healthcare investment driving market growth, finds report.
Lonza and Kodiak open custom-built bioconjugation facility
The newly opened facility will support the rapid launch and commercial manufacturing of KSI-301, Kodiak’s investigational retinal disease therapeutic.
EMA’s first critical medicines list for COVID-19
The approved COVID-19 vaccines and treatments on the list will be monitored to prevent and mitigate the impact of shortages.
Inflation/cost of goods major concerns for pharma manufacturing
Pharma industry calls for support as restrictive pricing measures and rising costs of goods/inflation could undermine the availability of medicines.
![Lonza Logo on top of grey building in Basel, Switzerland [Credit: Taljat David / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Lonza-1-300x278.jpg)
![Lonza Logo on top of grey building in Basel, Switzerland [Credit: Taljat David / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Lonza-1-e1654774052980.jpg)
Lonza’s latest: More sensitive non-endotoxin pyrogen detection now possible with Lonza’s new PyroCell® Monocyte Activation Test – Human Serum System
The PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS System) provides more sensitive detection of non-endotoxin pyrogen contaminants in pharmaceutical preparations.
Ensuring content uniformity for HPAPI products
Here, EPR discusses critical considerations to ensure content uniformity in HPAPI drugs produced using dry techniques.
AstraZeneca’s Evusheld significantly reduces risk of developing severe COVID-19
AstraZeneca's Evusheld (tixagevimab and cilgavimab) provided clinically and statistically significant protection against progression to severe COVID-19 over placebo.
Are closed systems the future of CGT sterility testing?
Researchers have identified, for the first time, a sensitive, low-risk, closed-system for the detection of fungal contaminants in cell and gene therapy (CGT) products.
HPAPI market to value $27bn by 2025
Driven by oncology drug demand, the highly potent active pharmaceutical ingredients (HPAPIs) market is anticipated to grow by $7bn in three years.
