News & Analysis on Clinical Trial Services & Contract Research And Development
Vedanta Biosciences has obtained fast track designation from the US Food and Drug Administration (FDA) for its live biotherapeutic VE303, a preventative treatment for recurrent Clostridioides difficile infection (CDI).
Xequel Bio has selected Societal CDMO to support the ongoing clinical development of a patented new chemical entity based on its aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) platform.
As part of a new initiative, the generic manufacturer will boost access to treatments for anxiety and depression across seven new states across the US, potentially reaching more than 650,000 uninsured patients.
The company unveils the creation of the Institute of Human Biology, which will provide efficacy studies of drug candidates using miniature ‘living replicas’ of human tissues and organs.
The company will build its ‘chemical innovation plant’ at its headquarters in Germany, improving its capacity for manufacturing chemical entities.
Cumulus Neuroscience has been given the clearance by the US Food and Drug Administration (FDA) and the company says this will accelerate treatments for neuropsychiatric and neurodegenerative disorders.