News & Analysis on Clinical Trial Services & Contract Research And Development
A regulatory expert has warned of the “unintended consequences” of that would require the US Food and Drug Administration (FDA) to begin reviewing drug candidates within 90 days of their approval in the EU.
With its purchase of Veropharm for up to $495m, Abbott is looking to tap into one of the largest Russian manufacturers of pharmaceuticals.
The Laupheim, Germany-based CMO (contract manufacturing organization) Rentschler Biotechnologie has invested €24m ($33m) to build a twin stainless steel bioreactor system.
Contract research organisations (CROs) have been slow to adopt next-generation means of recording study documents, with only 13% using the most up-to-date technologies, according to cloud-based services company Veeva.
US demand for biosimilars testing will grow substantially in the next few years according to BioOutsource, which expects to generate half of its revenue in the country by 2019.
UK API-maker and contract research organisation (CRO) Onyx Scientific is installing equipment for continuous flow manufacturing to offer customers an alternative to batch manufacturing.
Medichem has opened an API plant in Malta touting the country’s “unique patent situation” as an attractive option for generic drugmakers.
The US FDA approved Afrezza last weekend after deeming that the inhaled insulin drug and the dry powder delivery technology used to get it deep into the lungs is effective.