Pharmacovigilance – Products

CN Bio has announced that the U.S. Food and Drug Administration (FDA) has extended their research collaboration for a further three years.

GenNext Technologies, Inc., has announced that nearly $7M in NIH grant awards has led to a seminal US patent for its novel technology that vastly improves the utility of protein footprinting for the study of biopharmaceutical higher-order structure.

The Cambridge Crystallographic Data Centre (CCDC) announces the launch of CSD-Theory software for use in small molecule pharmaceutical development. This latest addition to the CCDC’s software toolbox delivers easy storage, management, search and display of crystal structure prediction results alongside experimental structures on a web-based platform and an API interface.

Viroclinics-DDL and ENPICOM have announced the approval of their joint MIT Zuid subsidy (SME Innovation Stimulation Top Sectors South Holland) application.

Waters Corporation has introduced a new peptide multi-attribute method (MAM) workflow for the Waters™ BioAccord™ LC-MS System, enabling drug development, manufacturing, and QC scientists to monitor efficacy and safety through the analysis of critical quality attributes (CQAs) of monoclonal antibodies (mAbs) and other protein-based drugs.

Download this whitepaper to discover approaches for the detection and quantification of HCPs that streamline the process of impurity monitoring, have broad sample applicability through mass spectrometry and consider patient safety, product stability and purity.

APEIRON Biologics AG, a privately held biotech company developing breakthrough therapies to treat cancer and respiratory conditions, announced today that APN01 (alunacedase alfa) treatment showed statistically significant improvements in specific areas for severely ill COVID-19 patients.

Johnson & Johnson has announced topline efficacy and safety data from the Phase 3 ENSEMBLE trial. Results demonstrate that the investigational single-dose COVID-19 vaccine met all primary and key secondary endpoints. The level of protection against moderate to severe COVID-19 was 72% in the US, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.

Novel test supports vaccine development studies critical to aiding researchers in understanding immunity levels and disease progression.