Decision On Bayer Probiotic Claim Could Weaken FTC Argument For Clinical Trials
This article was originally published in The Tan Sheet
FTC attempts through litigation, rather than rulemaking to establish RCTs as the standard for supplement claims, industry stakeholders say. The decision shows FTC “may not attempt to apply new standards … through contempt and threats of contempt,” says Jonathan Cohn, lead counsel for Bayer in the litigation.
You may also be interested in...
On behalf of the FTC, DoJ alleges Bayer violated a 2007 settlement to substantiate supplement claims and asks a court to require the firm to provide two RCTs for dietary supplement claims for Phillips’ Colon Health. Trade groups rally behind the firm, arguing the requirement is unfair and illegal.
Hikma and Civica Rx have announced the launch of a first wave of eight essential injectable medicines, including heparin, as part of a deal struck between the two firms earlier this year.
A PFS benefit and favorable tolerability profile associated with AstraZeneca’s BTK inhibitor acalabrutinib used first-line in CLL, when given alone or combined with obinutuzumab, may serve it well against entrenched competitors and BTK inhibitors in clinical development.