Shire announced top-line results from OPUS-2, a Phase 3 efficacy and safety study of 5.0% lifitegrast ophthalmic solution for dry eyes.
Eli Lilly and Company announced that the primary study objective from three studies of edivoxetine for superior efficacy was not met in depression after eight weeks of treatment.
Sanofi announced full results for EDITION II (basal insulin + oral therapy) and additional results from its EDITION Phase 3 program for EDITION III, EDITION IV, and EDITION JP I for the investigational new insulin U300 in patients with type 1 or type 2 diabetes.
The FDA has designated isavuconazole (Astellas Pharma) a Qualified Infectious Disease Product (QDIP) for the treatment of invasive aspergillosis.
The FDA has accepted the New Drug Application (NDA) for Zalviso (sufentanil sublingual microtablet system; AcelRx) for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
FibroGen announced interim results from an ongoing Phase 2 study evaluating FG-3019 for the treatment of idiopathic pulmonary fibrosis (IPF).
The FDA has accepted for review a New Drug Application (NDA) for Targiniq ER (oxycodone HCl/naloxone HCl controlled-release; Purdue Pharma) Tablets (CII) for the management of chronic pain.
The FDA has granted Fast Track designation to its lead clinical product candidate, CERC-301 (Cerecor ) for major depressive disorder (MDD).
Sanofi and Regeneron announced that in the SARIL-RA-MOBILITY Phase 3 clinical trial, sarilumab in combination with methotrexate (MTX) improved disease signs and symptoms as well as physical function, and inhibited progression of joint damage in adult patients with active rheumatoid arthritis (RA) who were inadequate responders to MTX therapy.
The FDA has issued a Complete Response Letter regarding the New Drug Application (NDA) for cariprazine (Forest Laboratories and Gedeon Richter Plc), an atypical antipsychotic for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.