The European Medicines Agency has knocked back Vivus Inc.’s Qsiva (phentermine/topiramate) for the treatment of obesity for a second time. The decision from the Committee for Medicinal Products for Human Use is likely to delay EU approval of the drug by at least two years.
Financings of the Fortnight takes note of pending IPOs and a largely self-financed Series C round by San Diego’s Elcelyx. Plus news on recent financings by Jounce Therapeutics, Retrophin and e-Therapeutics.
Receptor tyronsine kinase-focused Kolltan Pharmaceuticals looks to move into a new stage as it readies its first candidate for an IND and names a Chief Business Officer, Jane Henderson. Although Kolltan once had an option arrangement with Celtic Therapeutics, the company says its technology now is unencumbered by any options or partnerships.
Compounding pharmacy association says its position on non-traditional manufacturing is “not a major departure” from previous statements.