New Pipeline from Ivantis, Genentech, BeiGene and Endomag

August 20, 2018

Company Drug/Device Medical Condition Status
Amicus Therapeutics Galafold (migalastat) Fabry disease Approval granted by the FDA
Arbutus Biopharma Coporation and Alnylam Pharmaceuticals, Inc. ONPATTRO (patisiran) Hereditary transthyretin amyloidosis Approval granted by the FDA
Ivantis, Inc. Hydrus® Microstent, a microinvasive glaucoma surgery (MIGS) device Mild to moderate primary open-angle glaucoma in conjunction with cataract surgery Approval granted by FDA
Genentech Xlair® (omalizumab) Prevention of severe allergic reactions following accidental exposure to foods in people with allergies Breakthrough Therapy Designation granted by the FDA
Samsung Bioepis, Co., Ltd. SB26 ulinastatin-Fc (UTI-Fc) fusion protein Severe acute pancreatitis Phase I trial set to begin
Sesen Bio, Inc. Vicinium™ Non-muscle invasive bladder cancer (NMIBC) Granted Fast Track Designation by the FDA
BeiGene Ltd. Tislelizumab, an investigational anti-PD-1 antibody, combined with chemotherapy Potential first-line treatment for patients with Stage IIIB or IV squamous non-small cell lung
cancer (NSCLC)
Phase III clinical trial initiated
Eiger BioPharmaceuticals, Inc. Avexitide (formerly exendin 9-39) Post-bariatric surgical patients who experience post-bariatric hypoglycemia (PBH) Completion of enrollment in Phase II clinical trial
Izana Bioscience Namilumab Ankylosing spondylitis Phase II proof-of-concept clinical trial initiated
Rafael Pharmaceuticals, Inc. CPI-613 in combination with bendamustine Relapsed or refractory T-Cell Lymphoma Activation of a second clinical trial site for the Phase I study
Endomag Magtrace, the first non-radioactive, dual-tracer Lymphatic mapping in patients with breast cancer undergoing a mastectomy Granted premarket approval granted by the FDA
Cannabics Pharmaceuticals, Inc. Cannabics SR 5mg, daily for 3 months Advanced Cancer and Cancer Anorexia Cachexia Syndrome (CACS) Conclusion of trial announced; officials results are being evaluated
OrthoTrophix, Inc. TPX-100 Osteoarthritis Phase II trial results: improvements in function and cartilage in 55 percent of TPX-100 treated knees
Entasis Therapeutics ETX2514SUL Complicated urinary tract infections, including acute pyelonephritis (kidney infection) in adults Positive topline results from Phase II trial
Realm Therapeutics PR022 Atopic dermatitis Phase II trial failed to reach endpoint goals
INOVA Diagnostics, Inc. QUANTA Flash® HMGCR Aids in the diagnosis of idiopathic inflammatory myopathy (IIM), a group of conditions that affect the skeletal muscles Received FDA clearance