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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 |
