Moderna’s mRNA respiratory syncytial virus (RSV) vaccine candidate, mRNA-1345, gains Fast Track designation in adults over 60 years old.
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AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for patients with moderate to severe systemic lupus erythematosus.
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
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).
US President announces $60 million in funding to support domestic API production and a consortium to onshore essential medicine manufacturing.
The first interchangeable biosimilar insulin product will help increase access and affordability of insulin for diabetics.
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
FDA provides guidance on the validation and regulations for bio-fluorescent particle counting technology as an alternative, continuous method for bioburden testing in air and water systems.
Foreign biotech start-up? Uncle Sam wants you! (Despite the challenging funding application process)
Here, FreeMind Group’s Ayal Ronen explains the application process for funding by US Government agencies, exploring the challenges and potential benefits of applying for non-US entities.
The trial will assess orally administered pritelivir for the treatment of drug resistant mucocutaneous herpes simplex virus (HSV) infections in the immunocompromised.
Biopharma and the life sciences ecosystem: putting the foundations in place for a productive partnership
Even now 65 percent of drugs being approved come from biopharma companies and within a decade that is expected to rise to 85 percent. This is great news for a world hungry for new breakthrough treatments. As growth in pre-clinical and clinical work intensifies globally, Ahmed Bouzidi, Vice President of…
Physicochemical failure modes for first-line therapy Narrow Therapeutic Index (NTI) drugs: a call for attention NTI risk classification and New Prior Knowledge
In this article, Dr Harsh Shah and colleagues summarise their research into the importance of characterising physicochemical characteristics that can result in stress-induced solid-state changes in Narrow Therapeutic Index (NTI) drugs.
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.
Market research shows increasing pharmaceutical R&D investment and advances in quality control (QC) technologies will drive pharmaceutical QC market growth.