news
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.
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Biologics
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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…
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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.
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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.
video
On-demand webinar: ICH stability testing and method development
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
whitepaper
Whitepaper: Establishing the proper PH range for aqueous simulating solvents used in extractables profiling
This whitepaper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range).
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Biosimilars: the future of competition
Earlier this year, the British Biosimilars Association (BBA), the trade body representing the interests of biosimilar manufacturers, welcomed Dr Andrew Ellis as its new Chair. In this interview, Nikki Withers asks why biosimilars are so important for pharma and how he foresees the market evolving in the coming years.
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Expert view: Sterility testing of challenging samples
While membrane filtration is often straightforward, some sample types can be challenging. These include difficult-to-filter viscous oils, water-in-oil emulsions and fatty base ointments as well as samples containing substances that inhibit microbial growth.
news
4D pharma to initiate Phase II study of MRx-4DP0004 to treat COVID-19
The UK MHRA granted expedited acceptance for the Phase II trial of MRx-4DP0004, a live biotherapy product and targeted immunomodulatory therapy.
news
FDA transitions to new regulatory pathway for biosimilars
The US FDA will now approve biosimilars via a new regulatory pathway to help grow the competition between biologic products.
