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

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