Orphan Drug Status: Are Head-to-head Trials Needed To Show Superior Safety?
This article was originally published in The Pink Sheet Daily
CSL Behring petitions FDA to revoke Wilate's orphan drug designation, but Octapharma counters that the effectiveness of its product's dual viral inactivation processes can be seen in post-market reporting.
You may also be interested in...
In the first-ever rescission of marketing exclusivity for an orphan drug, FDA concludes that data does not show Wilate is superior to CSL Behring’s Factor VIII drug Humate-P. Wilate had previously been awarded orphan drug exclusivity for the same indication because of a “plausible hypothesis” that it was safer.
Serono has been informed by FDA that approval of its multiple sclerosis therapy Rebif is blocked by the orphan drug exclusivity of both Berlex' Betaseron and Biogen's Avonex, but has not been given a date for when that exclusivity will expire.
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.