The US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products.
Clinical trial operators are slowly converting to electronic Trial Master Files (eTMFs) but almost a third still rely on paper to manage data, according to cloud-based software provider Veeva.
WuXi PharmaTech has signed a strategic partnership deal to provide exclusive laboratory testing services to Hong Kong-headquartered Lee’s Pharmaceutical.
A drugmaker trialling an autoimmune disease treatment in the UK has become the first cleared to use electronic informed consent by the National Health Service (NHS).
API supplier Hepalink will buy Cytovance for $206m (€183m) in a deal the biologics CDMO says will help expedite its expansion plans.
Shire will use contractors to increase production of Cinryze, the half billion dollar-a-year Hereditary Angioedema (HAE) drug it bought with ViroPharma in 2014.