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