New Pipeline Updates from Abbott, Sanofi, Roche and Seqirus

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