US

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for anti-CD3-directed antibody TZIELD (teplizumab-mzwv), the first immunomodulatory treatment for type 1 diabetes (T1D).   It is approved for intravenous use to delay the onset of stage 3 T1D in adult and paediatric patients aged eight years and older with stage 2 […]

Merck has invested more than €290 million in its biosafety testing capacity at Rockville, Maryland, in the US.   The company says the investment will significantly increase the company’s ability to conduct biosafety testing and analytical development services, critical to the drug development and commercialisation process.  “These significant investments in Rockville and other sites across our […]

A new laboratory specialising in genomics is set to open at the North Carolina Research Campus (NCRC) in Kannapolis, North Carolina. The Bill and Shari Graham Genomics Laboratory is a collaborative project from Catawba College and Eremid Genomic Services. The Lab will offer the only undergraduate next-generation DNA sequencing (NGS) training in the United States. […]

A monoclonal antibody (mAb) treatment for the prevention of Malaria has shown encouraging results in a US Phase I clinical trial.   The mAb, known as L9LS, was developed by scientists at the National Institutes of Health’s (NIH) Vaccine Research Centre (VRC). L9LS is a laboratory-made version of a naturally occurring antibody called L9, developed from […]

Drug discovery and development company Cerevance has announced a multi-year strategic research collaboration with Merck (MSD), focused on identifying novel targets for Alzheimer’s disease.   Cerevance will receive an upfront payment of $25 million from Merck (MSD) and could receive development and commercial milestone payments of up to $1.1 billion, in addition to potential royalties on […]

An early-stage clinical trial has been launched in the US investigating a vaccine against Nipah virus infection.  The clinical trial has been launched by the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate an investigational vaccine to prevent infection with Nipah virus. The virus is being manufactured by pharmaceutical company Moderna and was […]