Report: Congress needs to update human research regulations
Ethical principles for conducting research involving humans were originally detailed in 1978 – today, a new report is urging Congress to make updates to the decades old document.
Archives for July 18, 2016
Evonik to buy CDMO for drug delivery technologies
Evonik has bought Transferra Nanosciences to expand its injectable drug delivery technology offering.
Constipation med linked to 46 B. cepacia cases in US recalled by PharmaTech
A constipation medication made by PharmaTech LLC has been recalled after being linked to an outbreak of the bacteria B. cepacia in five US states.
Update: Sandoz remains committed to launching 5 biosims by 2020
US FDA rejects Sandoz’s Neulasta biosimilar
The US FDA has issued Sandoz with a complete response letter for its Neulasta biosimilar.
China's complex API regs fuelling US meth problem says congressional committee
Legal loopholes and poor enforcement let criminals in China divert APIs for illegal drug production according to a US congressional committee which says the country is fast becoming the major global supplier of crystal meth precursors.
MilliporeSigma investing $115m in new North American hub
The 280,000-square-foot facility will be built in Burlington, Massachusetts and will include a customer collaboration laboratory and training center, in addition to office space.
FDA adds 4 API manufacturers to 'Red List'
Two Chinese and two Indian companies have been banned from importing APIs to the US – one manufacturer says it’s making GMP compliance a “priority.”