Endotoxin standards: reflection and recommendation
Dr Radhakrishna Tirumalai and Karen Zink McCullough reflect on the recent opportunity to update the user requirements document relating to reference endotoxin standards.
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Dr Radhakrishna Tirumalai and Karen Zink McCullough reflect on the recent opportunity to update the user requirements document relating to reference endotoxin standards.
Single-temperature incubation has been discussed for a long time in the pharmaceutical industry but only a few sites have implemented this system. Here, Guillaume Pinon, Head of the Microbiology Lab at Servier, discusses the use of single-temperature incubation in an aseptic production facility, outlining the regulatory considerations, strategic approach, challenges…
According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the EU general pharmaceutical legislation has potential to shape the future of EU actions against antimicrobial resistance (AMR).
Dr Neil Murray, Chief Executive of ReNewVax, explores the importance of new bacterial vaccines in the context of antimicrobial resistance and examines how the principle of reverse vaccinology could help to create more accessible and cost-effective vaccines.
The new COVID-19 vaccine authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) contains an adjuvant and is indicated to be given to patients over 16 years.
A 2022 WHO report is the first to portray COVID-19’s impact on the global vaccine market, identifying that lower-income countries struggle to access critical vaccines.
After previous reports that nearly all spinal muscular atrophy (SMA) patients treated with Zolgensma® achieved key motor milestones, Novartis announces publication of full SPR1NT results.
The expression of hydrophilins enables Acinetobacter baumannii to survive without water on hospital surfaces, providing a target for future elimination efforts and a pathway for biologic drug preservation.
18 November 2021 | By
The agreement enables the EU and European Economic Area (EEA) countries to donate Moderna's COVID-19 vaccine to low-income countries.
The license agreement between Pfizer and the Medicines Patent Pool (MPP) will enable access to Pfizer's antiviral candidate in 95 countries.
WHO recommends IL-6 antagonists plus corticosteroids for hospitalised COVID-19 patients based on their ability to reduce risk of death and the need for mechanical ventilation.
Global leaders at the G7 summit pledged 870 million COVID-19 vaccine doses, with half to be delivered by the end of 2021, to COVAX for distribution among low- and middle-income countries.
Stem cell therapy authorities urge the WHO to create an advisory committee for regenerative medicine and work to combat the rising use of unproven stem cell therapies worldwide.
Ahmed Bouzidi, VP of Biotech Strategic Development at ProductLife Group, discusses the opportunities – and funding and regulatory challenges – facing small and mid-sized biopharma companies as they deliver innovation to the global market.
To prevent the spread of the Ebola virus in West Africa, Johnson & Johnson is donating vaccines for a WHO early access clinical programme.