news
Saphnelo approved to treat systemic lupus erythematosus
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for patients with moderate to severe systemic lupus erythematosus.
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Drug Targets
article
FDARA implementation guidance for paediatric studies of molecularly targeted oncology drugs
This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original New Drug Application (NDAs) and Biological License Application (BLAs) are expected to be submitted to FDA, in accordance with The FDA Reauthorization Act (FDARA).
news
LBPs may offer hope to IBS patients in the near future, says report
Live biotherapeutic products (LBPs) are expected to help patients with IBS who currently have no US- or EMA-approved treatments.
news
Roche’s Evrysdi significantly improves lives of babies with SMA
The Phase II study of Evrysdi showed significant improvements in survival and motor milestones in babies with type 1 spinal muscular atrophy (SMA).
news
Alzheimer’s treatment lowers tau by nearly 50 percent in Phase I trials
Biogen and Ionis announced positive topline data on investigational Alzheimer’s treatment, indicating 50 percent tau protein reduction.
podcasts
EPR Podcast Episode 3 – Inhaled and intranasal drug formulations and delivery – Dr Bill Williams, University of Texas
Join Dr Bill Williams as he discusses formulation for inhaled and intranasal drug delivery and goes into detail about thin film freezing, a novel powder formulation technique he developed.
news
Big pharma collaborates on free resource linking genetic variants to human disease
The collaborative work has produced the largest browsable resource linking rare protein-coding genetic variants to human health and disease that will accelerate targeted drug development.
news
Phase III trial to assess pritelivir as a treatment for herpes simplex virus infections
The trial will assess orally administered pritelivir for the treatment of drug resistant mucocutaneous herpes simplex virus (HSV) infections in the immunocompromised.
news
First people dosed with a quadrivalent seasonal flu mRNA vaccine
The Phase I/II trial will assess the safety, reactogenicity and immunogenicity of Moderna’s mRNA-1010 seasonal flu vaccine.
news
GSK to collaborate on development of antibodies for neurodegeneration
GSK will support the development of Alector’s immuno-neurology monoclonal antibodies for Parkinson’s disease, frontotemporal dementia and Alzheimer’s.
news
US grants new patent targeting major neurodegenerative diseases
Alterity Therapeutics have been granted a patent for compounds able to redistribute excess iron in the brain being developed as a treatment for neurodegenerative diseases including Alzheimer's and Parkinson's.
news
Novel COVID-19 vaccine shows promise in Canadian trial
Phase I data shows VBI-2902a induced neutralisation and antibody titres up to five times that of people who had recovered from COVID-19 infection.
article
What are the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines?
In response to the COVID-19 pandemic caused by the SARS-CoV-2 virus, the emergence of RNA vaccine technology has enabled rapid development of critical vaccines. Traditional vaccine production methods makerapid development challenging, requiring cell line production of viral proteins and laborious purification development, which requires extensive effort and long timelines. RNA…
news
FDA approves Actemra for emergency use in hospitalised COVID-19 patients
The monoclonal antibody Actemra (tocilizumab) was approved for emergency use in hospitalised paediatric and adult COVID-19 patients based on results from four clinical trials.
news
Additional $12mn to fund further development of Marburg virus vaccine
BARDA has awarded more funding to Public Health Vaccines to support the development of a virally vectored vaccine against Marburg virus infections.
