Northera Confirmatory Trial Could Recruit Patients From Expanded Access Program
This article was originally published in The Pink Sheet Daily
FDA was unreceptive to Chelsea’s proposal to change endpoint in on-going 306B study to provide confirmatory efficacy data for droxidopa in neurogenic orthostatic hypotension.
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Northera Ongoing Trial May Satisfy FDA Request For More Efficacy Data, Chelsea Says
In a “complete response” letter to Chelsea for use of droxidopa in treating neurogenic orthostatic hypotension, FDA requests data from an additional trial showing efficacy and durability of effect. Chelsea believes ongoing Study 306, which has had its own efficacy challenges, could fill the bill and enable an NDA resubmission as early as the first quarter of 2013.
Not The Next Avastin? Plan For New ProAmatine Studies Would Negate Shire’s Withdrawal Hearing Request
A joint proposal from CDER and Shire calling for two new studies to verify clinical benefit of the hypotension agent would negate the need for a hearing on CDER’s proposed withdrawal, if Commissioner Hamburg accepts it.
Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.