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