ProQR and Lilly collaborate to develop RNA therapeutic
ProQR and Lilly announced a collaboration to combat genetic disorders in the liver and nervous system using Axiomer® RNA editing platform.
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Moderna and ILCM to develop Crigler-Najjar syndrome therapeutic
Moderna and the Institute for Life Changing Medicines (ILCM) are collaborating to develop an mRNA therapeutic for Crigler-Najjar syndrome.
EMA evaluates data on Comirnaty® COVID-19 vaccine booster dose
EMA begins evaluating the application for a booster dose of Comirnaty® in adults to be given six months after the second dose.
NICE recommends bimekizumab for severe plaque psoriasis treatment
Bimzelx® (bimekizumab) becomes the first medicine to be evaluated and recommended through NICE’s new Expedited Low-Risk Fast Track Appraisal.
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.
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.
