Drugs in the Pipeline

Drugs in the Pipeline

Hereditary Angioedema Tx Now a Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigation of DX-2930 (Dyax) for hereditary angioedema (HAE).

FDA to Review New Xeljanz Formulation for Rheumatoid Arthritis

Pfizer announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Xeljanz (tofacitinib citrate) 11mg once daily modified release tablets for the treatment of moderate to severe rheumatoid arthritis in patients with inadequate response or intolerance to methotrexate.

Volanesorsen Designated Orphan Drug Status for Familial Chylomicronemia Syndrome

The Food and Drug Administration (FDA) has granted Orphan Drug designation to volanesorsen (ISIS-APOCIIIRx; Akcea Therapeutics) for the treatment of patients with Familial Chylomicronemia Syndrome (FCS).

Gene Therapy Found to Improve Lung Function in CF

Gene therapy showed a significant benefit in lung function in patients with cystic fibrosis, data from a Phase 2 trial has shown.

Aerucin Awarded Fast Track for HAP/VAP

The Food and Drug Administration (FDA) has granted Fast Track designation to Aerucin (Aridis Pharmaceuticals) for the treatment of hospital-acquired and ventilator-associated pneumonia caused by Pseudomonas aeruginosa.

Investigational MS Tx Reduces Relapse Rate in Trials

Genentech announce positive results from two Phase 3 studies evaluating ocrelizumab compared with Rebif (interferon beta-1a) in patients with relapsing multiple sclerosis (MS).

Eteplirsen NDA Submission Completed for Duchenne Muscular Dystrophy

Sarepta Therapeutics announced that it has completed a rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for eteplirsen.

Emend Efficacious in Preventing Chemotherapy-Induced Nausea and Vomiting

Merck announced results from a Phase 3 study of single-dose Emend (fosaprepitant dimeglumine) for injection in combination with other anti-vomiting medications for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adult cancer patients receiving moderately emetogenic chemotherapy (MEC).

Egg-Free Flu Vaccine Beats Traditional Vaccine, Finds Study

Protein Sciences announced that Flublok Quadrivalent was better at preventing influenza than the traditional influenza vaccine.

FDA to Review NDA for Metastatic Pancreatic Adenocarcinoma Therapy

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for irinotecan liposome injection (MM-398; Merrimack Pharmaceuticals and Baxalta) for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.