Topic: regulatory affairs
Officials reiterated their intent for the U.K. to implement the incoming EU Clinical Trials Regulation and expanded on the long-term effect of Brexit.
The EMA now expects to lose 30% of its workers, up from the 19% predicted by its staff survey.
Beijing’s CANbridge Life Sciences, developing Western drug candidates in China and Asia, brought on Pfizer’s May Orfali to be chief medical officer.
The FDA finalized an eagerly awaited guidance on incorporating EHRs and real-world data into clinical trials, including from foreign sites.
The voted-for text tasks the government with seeking to secure the right for the U.K. to “fully participate” in the EMA after Brexit.
Already knowing Theranos’ story doesn’t make "Bad Blood" a less interesting read but offers a rare connection to its players as the scandal unfolds.
The German dermatology CRO Proinnovera has opened a new U.S. base of operations through a wholly owned subsidiary based in Wilmington, North Carolina.
Sanofi, Verily and Sensile Medical are teaming up to develop an “all-in-one” insulin patch pump, primarily aimed at patients with Type 2 diabetes.
LabCorp acquired postmarket services provider Sciformix and plans to integrate it with Covance. The terms of the deal were not disclosed.
Oncologie launched operations in Boston and Shanghai with a $16.5 million seed round, aiming to deliver drugs to China and the U.S. simultaneously.