Drugs in the Pipeline

Drugs in the Pipeline

Eravacycline Demonstrates Non-Inferiority in Intra-Abdominal Infection Trial

Tetraphase Pharmaceuticals announced positive results from Phase 3 IGNITE 1 trial of eravacycline for the treatment of complicated intra-abdominal infection (cIAI) compared to ertapenem.

Postherpetic Neuralgia Therapy Efficacious in Phase 3 Study

Pfizer announced top-line results from a Phase 3 study evaluating pregabalin controlled-release (CR) formulation in adult patients with postherpetic neuralgia (PHN).

FDA Issues Complete Response Letter for Yosprala

The Food and Drug Administration (FDA) has issued a second Complete Response Letter (CRL) in response to the New Drug Application (NDA) for Yosprala (aspirin and omeprazole delayed-release tablets) 81/40 and 325/40.

Bayer Submits BLA for Investigational Hemophilia A Drug

Bayer Healthcare has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in children and adults.

BLA Submitted for Investigational Hemophilia B Therapy

CSL Behring announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for rIX-FP (Coagulation Factor IX [Recombinant], Albumin Fusion Protein), its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin for patients with hemophilia B.

Genentech Submits NDA for Combination Melanoma Therapy

Genentech has submitted a New Drug Application (NDA) to the FDA for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma.

New Injection Site under FDA Review for Abilify Maintena

The Food and Drug Administration (FDA) has accepted for review Otsuka and Lundbeck's supplemental New Drug Application (sNDA) for a proposed new injection site, the deltoid muscle of the arm for Abilify Maintena (aripiprazole extended-release injectable suspension).

Improvement in ADHD Symptoms Observed in Dasotraline Trial

Sunovion announced positive results from the first placebo-controlled clinical trial of dasotraline for the treatment of adults with attention deficit hyperactivity disorder (ADHD).

Potential Ebola Hemorrhagic Fever Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Recombinant Nematode Anticoagulation Protein c2 (rNAPc2; ARCA biopharma) as a potential treatment of viral hemorrhagic fever post-exposure to Ebola virus.

Venetoclax Achieves Complete Response in Acute Myelogenous Leukemia Study

AbbVie announced results from a Phase 2 study of venetoclax (ABT-199/GDC-0199) in patients with acute myelogenous leukemia (AML).