Pipeline

September 24, 2018
Company Drug/Device Medical Condition Status
inui™ Health In-home urine analysis platform, which includes a disposable test and smart phone app (iOS and Android) Kidney function, metabolic disorders and urinary tract infections (UTI) Granted 510(k) clearance and a Clinical Laboratory Improvements Amendments (CLIA) waiver by the FDA CE Mark certification
Camurus CAM2038 Chronic low back pain Met primary and first secondary endpoints; resulted in significantly improved relief of the average and worst pain intensity compared to placebo
Iterum Therapeutics plc Sulopenem Gram-negative, multi-drug resistant infections Initiated SURE 2 and SURE 3 Phase III clinical trials
AstraZeneca Pharmaceuticals LP FASENRA™ (benralizumab) Severe eosinophilic asthma Phase III extension BORA trial results show long-term safety and efficacy as an add-on maintenance treatment
Regeneron Pharmaceuticals, Inc. and Sanofi Dupixent® (dupilumab) mono-therapy moderate-to-severe atopic dermatitis Phase III trial demonstrated a significant improvement in signs and symptoms
Alnylam Pharmaceuticals, Inc. Patisiran Polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults APOLLO Phase III trial showed improved markers of cardiomyopathy
AstraZeneca Triple combination therapy PT010 COPD Seeking FDA approval after Phase III trial found it outperformed its dual-therapy rivals eight of nine times
Teva Pharmaceutical Industries Ajovy (fremanezumab) Migraine Granted approval by the FDA
Venture Heat® Infrared Heat Therapy using Far infrared Rays (FIR) Pain Granted approval by the FDA
Sebacia, Inc. Sebacia Microparticles Mild to moderate inflammatory acne vulgaris Granted clearance by the FDA
WAT Medical HeadaTerm Migraine Granted clearance by the FDA
AstraZeneca Lumoxiti (moxetumomab pasudotox-tdfk) Adults with relapsed or refractory hairy cell leukemia (HCL) who have had at least two previous therapies Granted clearance by the FDA
Ironwood Pharmaceuticals, Inc. Praliciguat (IW-1973) Heart failure Granted Fast Track designation by the FDA
Genentech Subcutaneous (SC) formulation of Actemra® (tocilizumab) Active systemic juvenile idiopathic arthritis (SJIA) in patients two year and up Granted approval by the FDA
STAAR Surgical Company PMA Supplement for the Visian Toric ICL Myopia with astigmatism Granted approval by the FDA

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