In this interview, Joao discusses the molecules and products he reviews and how important it is to understand how they affect efficacy and safety in patients.
Read time: 00:30 mins
The US Food and Drug Administration (FDA) have announced a final guidance for industry, ’Bioanalytical Method Validation,’ is now available.
View time: 2:40 mins
We interview Vera Hillewaert, Scientist at Janssen Research & Development (NJ, USA), who discusses her research and the impact of rules and regulations.
Wacker Biotech GmbH (Jena, Germany) have announced that they will manufacture the active ingredient in the drug Retavase®. This drug has obtained FDA approval to treat acute myocardial infarction in adults.
The first biosimilar for the treatment of breast and stomach cancers has been approved by the FDA, termed Ogivri.
The vaccine will be the first and only two-dose vaccine in the USA for the prevention of hepatitis B in adults, and the first new hepatitis B vaccine in the USA in over 25 years.
Mersana Therapeutics (MA, USA), a biopharmaceutical company, announce FDA clearance of IND application for their new drug, XMT-1536.
This webinar will explore this continuum of fit-for-purpose validation, from the validation of early exploratory biomarker analysis, to the amalgamation of FDA GLP and CLIA GLP biomarker validation guidelines in the bioanalytical lab.
In this interview Mohsen Rajabi (FDA) discusses the process of FDA approval, why immunogenicity assays are so important and what he believes the future may hold for immunogenicity testing.
The FDA have approved Merck’s blockbuster drug Keytruda (pembrolizumab) to treat solid tumors on the basis of genetic characteristics rather than specific type and location.