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Pipeline
October 29, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Regeneron Pharmaceuticals and Sanofi | Dupixent (dupilumab) as an add-on maintenance therapy | Moderate-to-severe asthma | Granted approval by the FDA |
| Eiger BioPharmaceuticals, Inc. | lonafarnib | Hutchinson-Gilford Progeria Syndrome (HGPS or progeria) and progeroid laminopathies | Granted Rare Pediatric Disease (RPD) designation by the FDA |
| Abbott | HeartMate 3™ Left Ventricular Assist Device (LVAD) | Advanced heart failure | Granted approval by the FDA |
| Bristol-Myers Squibb | Combination of Opdivo and Yervoy | Peviously untreated advanced or metastatic renal cell carcinoma (RCC) | Yielded a significantly longer treatment-free survival period than sunitinib, the standard of care, in Phase III clinical trial |
| Takeda Pharmaceutical Company | Investigational subcutaneous formulation vedolizumab | Moderately to severely active ulcerative colitis | Significant portion of patients in Phase III VISIBLE 1 clinical trial show achieved clinical remission |
| Roche | Xofluza (baloxavir marboxil) | Flu in patients 12 years of age and older | Granted approval by the FDA |
| Incyte Corporation | ruxolitinib (Jakafi®) | Acute graft-versus-host-disease (GVHD) inpatients with inadequate response to corticosteroids | FDA accepted its supplemental New Drug Application (sNDA) for priority review |
| Scarless Laboratories, Inc. | Novel therapeutic peptide, SLI-F06 | Scar reduction | Granted clearance by the FDA to enter a Phase I/IIa clinical trial |
| CStone Pharmaceuticals | Monoclonal antibody (mAb) CS1003 | Cancer | FDA approved company's Investigational New Drug (IND) application |
| Avita Medical | RECELL® Autologous Cell Harvesting Device (RECELL® System) | Superficial partial- and mid-thickness pediatric burns, including scald injuries | Beginning of a randomized, controlled clinical trial |
| Seqirus | AFLURIA® QUADRIVALENT (Influenza Vaccine) | Flu in patients six months and older | Granted approval by the FDA |
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