FDA surveillance of its own employees was approved by agency lawyers. Some of the intercepted communications may have been with Washington politicians. The surveillance program is no longer ongoing, but unearthed some 80,000 pages of documents, some of which were inadvertently posted online by an FDA contractor. Here are articles from Slate and the Washington Post.
Is the clinical trial management system (CTMS) market shrinking? It is still surprising that an essential part of the clinical trial software landscape remains obscure and unexamined. A new report says annual industry spending on all eclinical technologies may be $1.4 billion, but doesn't itemize the CTMS market or attempt to estimate how many CTMS are bundled into larger packages of software and given away for free.
After a recent merger with PMG Research, Inclinix has tripled revenues, in part thanks to thirty new sites for research. That's the word from this business newspaper article, which says the North Carolina company will be exploring joint ownership with principal investigators and fresh marketing efforts.
A new group of European drug safety officials held its first meeting in Brussels to avoid the general confusion of the London Olympics. The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) intends to implement new continental legislation about reporting and monitoring drug safety issues. At the risk of stating the obvious, this may take a while. “The establishment of the PRAC will make the existing system even more robust,” said Guido Rasi, executive director of the EMA, “as we will now have a dedicated committee responsible for assessing and monitoring safety issues for human medicines.”
After an inspection, the FDA blocked imports from Hemofarm, one of the largest biopharma companies in Serbia. The potential issue is contamination of a manufacturing process by bacteria. The national authorities in Serbia are trying to verify the FDA findings. Here's a news brief.
Parexel announced a partnership with the South Korea Drug Development Fund (KDDF). A consortium of government agencies and academic centers, the KDDF intends to spend $1 billlion to develop ten new drugs through 2019. Someone may want to suggest that the Koreans move a few decimal points: After spending $100 milllion (or one tenth of a billion dollars), some savvy global firms would consider themselves lucky to find a single new compound. Here's a news release.