Protocols

FDA slams Vernalis with 2nd CRL in 3 months; Former Shkreli company KaloBios changes name

Ian Garland, Vernalis

→ Three months after the FDA rejected its tweaked cold remedy CCP-07, Vernalis says regulators have followed up by putting CCP-08 into the dog house as well. “Unfortunately, the outstanding items that resulted in a CRL for CCP-07 could not be addressed in time to avoid the same outcome for CCP-08. The approval of both CCP-08 and CCP-07 are of the utmost importance to Vernalis, and we are working closely with our partner Tris and the FDA to resubmit both NDAs as quickly as possible,” said Ian Garland, CEO of Vernalis. “We look forward to providing additional updates on our progress with this in the coming months.”

→ Shares of Australia’s Starpharma (OTCQX: SPHRY) surged after it said that its two Phase III trials of VivaGel BV for prevention of recurrent bacterial vaginosis (rBV) achieved their primary objective.

→ KaloBios, once briefly owned and controlled by notorious bad boy Martin Shkreli, officially changes its name today to Humanigen.


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RAPS Regulatory Convergence 2017