Membrane technologies to be critical in intensifying downstream bioprocessing
Experts suggest membrane-based technologies could become a vital component in end-to-end intensified bioprocesses for monoclonal antibodies.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.
European Pharmacopoeia publishes new chapter on balances
The new general chapter, Balances for analytical purposes (2.1.7), sets out clear requirements for equipment that is the cornerstone of every analytical procedure in the European Pharmacopoeia.
FDA reaches over 100 Competitive Generic Therapy approvals
The FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation.
Single step antibody capture and clarification for intensified bioprocesses
Research shows magnetic beads coupled with protein A can clarify very high cell concentrations and capture antibodies with high efficiency in a single step.
EC approves Ultomiris for children and adolescents with PNH
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
Phase III clinical trial for respiratory syncytial virus (RSV) vaccine begins
Pfizer’s RENOIR Phase III trial will evaluate the efficacy, immunogenicity and safety of their respiratory syncytial virus (RSV) vaccine.
BioNTech evaluates mRNA vaccine manufacturing capabilities in Africa
BioNTech will evaluate mRNA vaccine manufacturing facilities in Rwanda and Senegal to support vaccine supply in African states.
FDA approves Invega Hayfera™ for the treatment of schizophrenia
Janssen announced US FDA approval of Invega Hayfera, the first and only twice-yearly treatment for adults with schizophrenia.
Fostamatinib reduces COVID-19 risks by 50 percent in Phase II study
Fostamatinib significantly reduced serious adverse effects and risk of death in hospitalised COVID-19 patients, shows Phase II study.
NMR spectroscopy to enhance biologic drug delivery and stability
Review shows nuclear magnetic resonance (NMR) spectroscopy has the potential to enhance biologic drug formulation, optimising delivery and bioavailability.
HIV vaccine fails to protect women against infection
The investigational vaccine tested in sub-Saharan Africa posed no safety concerns but did not provide sufficient HIV protection.
NICE approves inclisiran for LDL cholesterol reduction
The UK approval follows a Phase III study in which Leqvio® (inclisiran) reduced low-density lipoprotein cholesterol (LDL-C) by 55 percent.
Dupixent® reduces atopic dermatitis by 70 percent in Phase III trial
Dupixent is the first biologic medicine to significantly reduce signs and symptoms of atopic dermatitis in children as young as six months.
Pharmaceutical membrane filtration market to value $10 billion by 2025
Growth in the global pharmaceutical membrane filtration market will be driven by the increasing adoption of single-use technologies.
