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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.
The FDA has granted priority review of the Biologics License Application for sutimlimab to treat haemolysis in patients with cold agglutinin disease (CAD).
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
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).
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.
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.
The UK MHRA granted expedited acceptance for the Phase II trial of MRx-4DP0004, a live biotherapy product and targeted immunomodulatory therapy.
The US FDA will now approve biosimilars via a new regulatory pathway to help grow the competition between biologic products.
Researchers report that a patient who underwent stem-cell transplantation and a chemotherapy drug regimen has been cured of HIV.
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.
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?
The two agencies have signed a statement of their intent to combat anti-competitive practices which are preventing the adoption of biosimilars in the US drug market.
New research has suggested that the expiration of biologics patents will be the factor that positively impacts US pharma the most this year.
Pharmaceutical industry experts have highlighted the key trends for the coming year for drug delivery and packaging.
