As NASH Space Heats Up, Tobira Strengthens Position With Regado Reverse-Merger
This article was originally published in The Pink Sheet Daily
New combined company, with $60 million in cash, is hoping to move quickly to fill the unmet medical need of non-alcoholic steatohepatitis. Tobira expects primary endpoint data from a Phase IIb study of cenicriviroc by the second quarter of 2016.
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In this week's podcast edition of Five Must-Know Things: a preview of the CTAD Alzheimer’s meeting; US myeloma drug withdrawal puts pressure on GSK; UniQure/CSL's gene therapy sets new US price record; new leadership at Teva; and Merck’s Frazier cautions against profit maximization.
Attention must be paid when withdrawal is for NDA approved in 1948 for brand synonymous with nonprescription pain relief, Bufferin. Even when FDA’s decision amounts to NDA database recordkeeping, withdrawal of application demands notice in US OTC space.