Home » Pipeline
Pipeline
January 7, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Pfizer, Inc. | PF-06651600 (oral JAK3 inhibitor) | moderate to severe alopecia areata | Phase II/III trial initiated enrolling 660 subjects |
| Slayback Pharma LLC | Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml | risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth | ANDA approval granted by the FDA |
| I-Mab Biopharma | TJM2, a humanized immunoglobulin G1 (IgG1) targeting granulocyte-macrophage colony-stimulating factor (GM-CSF) | autoimmune and inflammatory diseases | IND approval granted by the FDA |
| Cardiva Medical, Inc. | VASCADE MVP Venous Vascular Closure System | electrophysiology procedures | PMA approval granted by the FDA |
| Eiger BioPharmaceuticals, Inc. | lonafarnib | hepatitis delta virus (HDV) infection | PRIME (PRIority MEdicines) designation granted by the EMA |
| Horizon Pharma plc | RAVICTI (glycerol phenylbutyrate) Oral Liquid | infants younger than two months of age living with a urea cycle disorder (UCD) | sNDA approval granted by the FDA |
| Edwards Lifesciences Corporation | SAPIEN 3 Ultra system | transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery | Approval granted by the FDA |
| Sanofi and Merck | Vaxelis (ready-to-use hexavalent vaccine) | prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenza type b | Approval granted by the FDA |
| Alexion Pharmaceuticals | Ultomiris | paroxysmal nocturnal hemoglobinuria (PNH) | Approval granted by the FDA |
| Stemline Therapeutics | Elzonris | blastic plasmacytoid dendritic cell neoplasm (BPDCN) | Approval granted by the FDA |
| Teva Pharmaceutical Industries Ltd. | ProAir Digihaler (albuterol sulfate 117 mcg) inhalation powder | asthma and COPD | Approval granted by the FDA |
| Acorda | Inbrija | intermittent treatment of OFF episodes in Parkinson’s disease patients taking Carbidopa/Levodopa | Approval granted by the FDA |
| Merck | KEYTRUDA | recurrent locally advanced or metastatic Merkel cell carcinoma (MCC) | Approval granted by the FDA |
| Veloxis Pharmaceuticals | Envarsus XR (tacrolimus extended-release tablets) | organ rejection in kidney transplant patients | Approval granted by the FDA |
| AstraZeneca and Merck | LYNPARZA | deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer | Approval granted by the FDA |
| Medtronic plc | InterStim smart programmer | overactive bladder (OAB), chronic fecal incontinence (FI) and non-obstructive urinary retention | Approval granted by the FDA |
| Celltrion, Inc. and Teva Pharmaceuticals Industries Limited | HERZUMA (trastuzumab-pkrb) | treatment of HER2-overexpressing breast cancer for certain indications | Approval granted by the FDA |
