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Pipeline
July 30, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Tolero Pharmaceuticals, Inc. | TP-0184, an activin A receptor type 1 (ACVR1) | advanced solid tumors | Phase I trial initiated |
| Sangamo Therapeutics, Inc. | SB-318 | mucopolysaccharidosis type I (MPS 1, Hurler syndrome) | Phase I/II trial initiated enrolling up to 9 adult subjects |
| Dermtreat | Rivelin Clobetasol patch (Rivelin-CLO) | oral lichen planus (OLP) | Phase IIb trial initiated enrolling 240 subjects |
| Biohaven Pharmaceutical Holding Company Ltd. | trigriluzole (BHV-4157) | mild-to-moderate Alzheimer’s disease (AD) | Phase II/III trial initiated enrolling 292 subjects |
| MED-EL USA | BONEBRIDGE bone conduction hearing implant system | individuals 12 years and older who have been diagnosed with conductive hearing loss, mixed hearing loss or single-sided deafness | De Novo clearance granted by the FDA |
| CarboFix Orthopedics LTD. | CarboClear Fiber Pedicle Screw System | patients with advanced-stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion | 510(k) clearance granted by the FDA |
| Cepheid | Xpert Xpress Flu/RSV test | influenza A and B viruses | 510(k) clearance granted by the FDA |
| Allergan plc | AGN-241751 | Major Depressive Disorder (MDD) | Fast Track Designation granted by the FDA |
| Flashback Technologies | CiperOx CRI M1 monitor | detection and monitoring of acute blood loss | Clearance granted by the FDA |
| LifeSignals | LP1100 Life Signal Patch | healthcare monitoring devices | Clearance granted by the FDA |
| AbbVie and Neurocrine Biosciences, Inc. | ORILISSA (elagolix) | moderate to severe endometriosis pain | Approval granted by the FDA |
| Ology Bioservices, Inc. and Rafa Laboratories Ltd. | Atropine Autoinjector | chemical nerve agent poisoning | Approval granted by the FDA |
| Devicor Medical Products, Inc. | Magtrace and Sentimag Magnetic Localization System (Sentimag System) for guiding sentinel lymph node biopsies | breast cancer | Approval granted by the FDA |
| Senseonics and Integrated Device Technology, Inc. | Eversense Continuous Glucose Monitoring (CGM) System | Diabetes | Approval granted by the FDA |
| Pfizer Inc. | NIVESTYM (filgrastim-aafi) | neutropenia | Approval granted by the FDA |
| Agios Pharmaceuticals | ivosidenib (Tibsovo) | specific gene mutation IDH1 found in patients with acute myeloid leukemia (AML) or those patients who have relapsed or do not respond to standard chemotherapy | Approval granted by the FDA |
