Drugs in the Pipeline

Gazyva Goes Head-to-Head with Rituxan in Follicular Lymphoma Study

Gazyva Goes Head-to-Head with Rituxan in Follicular Lymphoma Study

Genentech announced positive results from the pivotal Phase 3 GALLIUM study.

FDA Continues Review of Controversial DMD Treatment

FDA Continues Review of Controversial DMD Treatment

Sarepta announced that the Food and Drug Administration (FDA) is continuing the pending New Drug Application (NDA) review for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).

Filgotinib Achieves Clinical Remission in Crohn's Disease Study

Filgotinib Achieves Clinical Remission in Crohn's Disease Study

Galapagos announced positive study data from the Phase 2 trial, FITZROY, evaluating filgotinib for the treatment of Crohn's Disease. Detailed results were presented at Digestive Disease Week 2016 in San Diego, CA.

Positive Results for Potential Bacterial Vaginosis Treatment Announced

Positive Results for Potential Bacterial Vaginosis Treatment Announced

Symbiomix announced positive results from the second pivotal Phase 3 trial of SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV).

Investigational Tx Granted Orphan Drug Status for Spinocerebellar Ataxia

Investigational Tx Granted Orphan Drug Status for Spinocerebellar Ataxia

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Biohaven's investigational agent BHV-4157 for the treatment of Spinocerebellar Ataxia (SCA).

FDA Grants Antifungal Orphan Drug Status for Valley Fever

FDA Grants Antifungal Orphan Drug Status for Valley Fever

The Food and Drug Administration (FDA) has granted Orphan Drug designation to VT-1598 (Viamet) for the treatment of coccidioidomycosis or Valley Fever, a common lung infection in the southwestern US.

Maintenance Treatment with Stelara Evaluated in Crohn's Disease Study

Maintenance Treatment with Stelara Evaluated in Crohn's Disease Study

Janssen announced new data from the Phase 3 study, IM-UNITI, showing that a significantly greater proportion of adult patients with moderate to severe Crohn's disease receiving maintenance treatment of Stelara (ustekinumab) achieved clinical remission at one year. Study findings were presented for the first time at Digestive Disease Week 2016.

FDA to Review Topical Rosacea Treatment

FDA to Review Topical Rosacea Treatment

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for oxymetazoline HCl cream 1% (Allergan) for the treatment of persistent facial erythema associated with rosacea in adults.

Positive Phase 3 Results for Chronic Idiopathic Constipation Drug

Positive Phase 3 Results for Chronic Idiopathic Constipation Drug

Synergy announced additional clinical data from two Phase 3 trials, Study-00 and Study-03, evaluating the efficacy and safety of plecanatide for the treatment of chronic idiopathic constipation (CIC). Study findings were presented at Digestive Disease Week (DDW) in San Diego.

Sublingual Cyclobenzaprine Shows Promise in PTSD Study

Sublingual Cyclobenzaprine Shows Promise in PTSD Study

Tonix Pharmaceuticals announced topline results from the Phase 2 AtEase Study, evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of military-related Post-Traumatic Stress Disorder (PTSD).

FDA Grants Vyxeos Breakthrough Therapy Status for AML

FDA Grants Vyxeos Breakthrough Therapy Status for AML

Celator announced that the FDA has granted Breakthrough Therapy designation to Vyxeos (CPX-351) for the treatment of adults with therapy-related acute myelogenous leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Novel Gene Tx Fast Tracked for ALS

Novel Gene Tx Fast Tracked for ALS

The FDA has granted Fast Track designation for the investigational drug, VM202 (VM BioPharma/ViroMed), for the potential treatment of Amyotrophic Lateral Sclerosis (ALS).

FDA Designates Selumetinib Orphan Drug for Differentiated Thyroid CA

FDA Designates Selumetinib Orphan Drug for Differentiated Thyroid CA

AstraZeneca announced that the FDA has granted Orphan Drug designation to selumetinib for the adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC).

Novel Asthma Biologic Demonstrates Efficacy in Two Phase 3 Studies

Novel Asthma Biologic Demonstrates Efficacy in Two Phase 3 Studies

AstraZeneca announced that two pivotal Phase 3 registrational trials for benralizumab achieved their primary endpoint, demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo.

Orphan Drug Status Granted to Hyperoxaluria Treatment

Orphan Drug Status Granted to Hyperoxaluria Treatment

The FDA has granted Orphan Drug designation to ALLN-177 (oxalate decarboxylase; Allena) for the treatment of pediatric hyperoxaluria.