Drugs in the Pipeline

Drugs in the Pipeline

Coagadex Amended BLA Under Review for Rare Bleeding Disorder

The Food and Drug Administration (FDA) has accepted for review the amended Biologics License Application (BLA) for Coagadex (coagulation factor X, human) for hereditary X deficiency.

Results Announced From Phase 3 Trial of Combo COPD Therapy

Novartis announced results from its Phase 3 EXPEDITION trial for indacaterol/glycopyrronium (QVA149) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Orphan Drug Status Granted to Ovarian Cancer Therapy

The Food and Drug Administration (FDA) has granted Orphan Drug designation to CRLX101 (Cerulean Pharma) for the treatment of ovarian cancer.

Combination COPD Therapy Improves Lung Function in Trials

Boehringer Ingelheim announced new data analyses from the Phase 3 TONADO 1&2 studies of tiotropium/olodaterol delivered via Respimat inhaler for chronic obstructive pulmonary disease (COPD).

Sarilumab Improves Physical Function in Rheumatoid Arthritis Trial

Regeneron and Sanofi announced results from their Phase 3 SARIL-RA-TARGET trial of sarilumab in patients with rheumatoid arthritis (RA).

Optina Efficacious in Diabetic Macular Edema Study

Ampio Pharmaceuticals announced positive results from the OptimEyes Trial for Optina in patients with diabetic macular edema (DME).

Dyanavel XR NDA Accepted for FDA Review

Tris Pharma announced that the Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for Dyanavel XR (amphetamine) CII, an Extended-Release Oral Suspension.

Rare Neurologic Disorder Therapy Designated Orphan Drug

The Food and Drug Administration (FDA) has granted Orphan Drug designation to revusiran (Alnylam) for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR amyloidosis).

Investigational HCV Tx Receives Amended Breakthrough Designation

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy designation for the investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients.

Progression-Free Survival Seen With Enzalutamide for Prostate Cancer in Phase 2 Trial

Astellas Pharma and Medivation announced data from the Phase 2 STRIVE trial comparing Xtandi (enzalutamide) and bicalutamide in non-metastatic (M0) and metastatic (M1) prostate cancer patients whose disease progressed despite treatment with a luteinizing hormone-releasing hormone (LHRH) analogue therapy of following surgical castration.