Tag Archives: QIDP

Basilea Launches FORWARD‑IM Phase 3 Trial of Fosmanogepix in Invasive Mold Infections

(IN BRIEF) Basilea Pharmaceutica has initiated FORWARD‑IM, a global Phase 3 trial evaluating fosmanogepix in adults with invasive mold infections. Building on positive Phase 1 and Phase 2 results—and following the FAST‑IC Phase 3 candidemia trial—this open‑label study will randomize about 160 patients to … Read the full press release

BARDA Invests Additional USD 39 Million to Accelerate Phase 3 Trials of Basilea’s Fosmanogepix and BAL2062

(IN BRIEF) Basilea Pharmaceutica has secured an extra USD 39 million from BARDA under its Other Transaction Agreement, bringing potential non-dilutive funding to USD 268 million over 12 years. This new tranche will finance the ongoing phase 3 trial of … Read the full press release

U.S. FDA designated Basilea Pharmaceutica’s isavuconazole as Qualified Infectious Disease Product (QIDP) for the treatment of invasive aspergillosis

Basel, Switzerland, 11-12-2013 — /EuropaWire/ — Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive aspergillosis. QIDP status provides priority review and … Read the full press release