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.
List view / Grid view
Biologics
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.
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).
article
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.
article
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.
news
Second patient cured of HIV using stem cell therapy
Researchers report that a patient who underwent stem-cell transplantation and a chemotherapy drug regimen has been cured of HIV.
news
Coronavirus update: clinical trials and antibody manufacture
The US NIH has initiated a clinical trial for remdesivir and two pharmaceutical companies will work together to manufacture antibody treatments to tackle the coronavirus.
article
How will the rise of biosimilars impact biologics?
Once patents expire for biologic medicines, a market opportunity opens up for biosimilars, a cheaper alternative. With more patents due to expire soon, what will the future look like for biologic medicines?
