Drug developers with questionable data beware. The FDA is taking no prisoners, and handing out no approvals, for developers suffering from data integrity issues. That's the world from In Vivo, which tracked Theravance's removal of data from one study site before a scheduled advisory committee meeting on its antibiotic, televancin. Theravance insisted the data removal had no "material impact" on its filings. But Senator Charles Grassley recently staked out his opposition to resolving any data issues by simply removing the data in question. The FDA canceled the meeting, which In Vivo attributes to Grassley's heated stance, and Theravance was left vowing to commit to working with the FDA.
"Other NDA sponsors would be well advised to pay more attention to all pending data integrity issues for products nearing the review stage," advises the blog. "The agency's division of scientific investigations is clearly emboldened and carrying more weight within FDA from Grassley's attention."
- read the post [1] at In Vivo
ALSO: Theravance shares fell to an all-time low after the company announced plans to review trial sites used to test the therapy. Release [2] | Report [3]
Related Articles:
FDA wants more data on Theravance antibiotic. Report [4]
Theravance trumpets positive results of mid-stage trial. Report [5]
Astellas take a pass on Theravance's drugs. Report [6]
Links:
[1] http://invivoblog.blogspot.com/2008/03/telavancin-delayed-by-grassleys-ketek.html
[2] http://www.fiercebiotech.com/press-releases/theravance-receives-additional-information-regarding-fda-cancellation-advisory-commit
[3] http://www.chron.com/disp/story.mpl/ap/fn/5590510.html
[4] http://www.fiercebiotech.com/story/fda-wants-more-data-theravance-antibiotic/2007-10-22
[5] http://www.fiercebiotech.com/story/theravance-trumpets-positive-results-of-mid-stage-trial/2007-06-26
[6] http://www.fiercebiotech.com/story/also-noted-novartis-sinks-816-5m-italian-vaccine-plant-gsk-astellas-take-pass-theravances-drug