Vaccine company Valneva has been awarded Breakthrough Therapy Designation for its single-shot chikungunya vaccine candidate, VLA1553, by the US Food and Drug Administration (FDA).
The US FDA has released draft guidance documents on gene therapy programmes, which “should help sponsors avoid expending time and resources on unproductive drug development efforts,” says expert.
Did you miss any of the biosimilar approvals, launches or guidance this year? Well Biopharma-Reporter brings you a special timeline of events to help guide you into the new year.
Novasep has joined the growing number of manufacturers betting on the antibody drug conjugate (ADC) market with a €3m investment at its plant in Le Mans, France.
Thermo Fisher Scientific has launched a predictive assay that, it claims, can assess a drug candidate’s potential to cause liver damage earlier than traditional methods.
