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Pipeline
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 |
