news
FDA issues emergency use authorisation for COVID-19 convalescent plasma
The emergency use authorisation (EUA) allows the distribution and administration of COVID-19 convalescent plasma to hospitalised patients in the US.
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Biologics
news
India gives nod to cell therapy for Critical Limb Ischemia (CLI)
Stempeucel®, a cell therapy for the treatment of Critical Limb Ischemia (CLI), has been approved for commercial use in India by the Drug Controller General.
whitepaper
Application note: Automated ELISA solutions – workflow intelligence guide
ELISA protocols involve an exhausting number of dispensing, washing and incubating steps. Get your guide to automated ELISA workflow intelligence here.
whitepaper
Application note: Miniaturised multi-piece DNA assembly
The Echo Liquid Handler has demonstrated the ability to generate DNA constructs using various assembly chemistries with a miniaturised protocol.
news
Oral bacteriotherapy improved outcomes in COVID-19 patients
Clinical trial testing a live biotherapeutic in hospitalised COVID-19 patients suggests the bacteriotherapy could be promising.
article
Biosimilar uptake will take more than competitive pricing
This article explores what pharmaceutical companies could be doing to promote injectable biosimilar approval and consumer uptake.
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TXA127 enters multiple Phase II trials in COVID-19 patients
A pharmaceutical formulation of the human angiotensin peptide, TXA127, will enter Phase II trials in hospitalised COVID-19 patients not in intensive care.
article
How to start up an ATMP clinical trial
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues or cells. They offer revolutionary opportunities for the treatment of disease and injury; however, developers face a complex regulatory and developmental landscape to bring ATMPs to market. Here Magdalena Czarnecka offers guidance and advice on effectively initiating an ATMP…
article
Five patent issues that European biosimilar developers should consider before entering the US market
As patents on originator biologic medicines begin to expire, there are growing opportunities for biosimilars to enter the market at lower prices. Joshua Whitehill, Natasha Daughtrey and Grace Truong discuss key aspects of US patent law that European developers should consider before entering the American market.
news
Second of Lilly’s COVID-19 neutralising antibodies begins Phase I trials
The first patient has been dosed in the Chinese Phase I trial of JS016 in healthy people who do not have a COVID-19 diagnosis.
news
Are thermally stable, ensilicated vaccines the future for childhood inoculations?
Coating the tetanus portion of the DTP vaccine in silica rendered it thermally stable up to 100°C and able to be distributed without refrigeration.
news
Lilly launches Phase I trial of investigational COVID-19 antibody treatment
The enterprise announced the initiation of the LY-CoV555 COVID-19 antibody treatment trial at medical centres across the US.
whitepaper
Whitepaper: Rapid sterility testing: a new solution for short shelf life products
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
news
FDA grants priority review to Biologics License Application for sutimlimab
The FDA has granted priority review of the Biologics License Application for sutimlimab to treat haemolysis in patients with cold agglutinin disease (CAD).
video
On-demand webinar: Microbiological control in a pharmaceutical manufacturing environment
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
