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.
Who are the people behind the science? We interviewed key experts to uncover who their bioanalytical hero is. In this series we sit down with Chad Briscoe (PRA Health Sciences), Joy Concepcion (Gyros Protein Technologies), Caitlin Dunning (Waters Corporation), Mike Godeny (Merck KGaA), Sankeetha Nadarajah (Bioanalysis), Steve Piccoli (WRIB), Nikunj Tanna (Waters Corporation) and Amanda Wilson (Astrazeneca).
Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments
Bioanalytical methods must enable the delivery of data that meet sound, scientifically justified, fit-for-purpose criteria. This perspective piece highlights three tiers of method validation – regulatory, scientific and research validations. The criteria for selecting the appropriate application of each of these PK method validation workflows are discussed.
MSD Research Laboratories (NJ, USA) announces the establishment of a new life sciences discovery research facility, which will be based in London.
Alturas Analytics and Metrendalytics announce new technology to streamline operations in the modern scientific laboratory
Alturas Analytics (ID, USA) and Metrendalytics (NJ, USA) have announced a new information system combining common laboratory software programs into a single system.
The first biosimilar for the treatment of breast and stomach cancers has been approved by the FDA, termed Ogivri.
In this commentary, Melanie Anderson discusses the use of paper-based dried sampling technologies and how they can provide opportunities to collect biological samples in the dried state, which involves significantly smaller sample volumes than traditional sample collection approaches.
MorphoSys (Munich, Germany) has announced that its licensee Janssen (Beerse, Belgium) has gained approval for Tremfya® in Europe. The monoclonal antibody is used for the treatment of plaque psoriasis.
The Good Clinical Laboratory Practice accreditation will enable the company to extend its proteomic services to the analysis of clinical trial samples.
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.