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Pipeline
April 1, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| International AIDS Vaccine Initiative (IAVI) | BG505 SOSIP.664 gp140 | HIV | Phase I trial initiated enrolling 60 healthy adult subjects in Seattle, Boston and Nairobi |
| Aerie Pharmaceuticals, Inc. | netarsudil ophthalmic solution | open-angle glaucoma or ocular hypertension | Phase II trial initiated enrolling 208 subjects in Japan |
| DURECT Corporation | DUR-928 (topical) | mild to moderate plaque psoriasis | Phase IIa trial initiated enrolling 20 subjects at multiple sites across the U.S. |
| Modra Pharmaceuticals B.V. | ModraDoc006/r | recurrent or metastatic HER-2 negative breast cancer | Phase IIa trial initiated enrolling 24 subjects |
| Urovant Sciences | vibegron | overactive bladder (OAB) in men who are receiving pharmacological treatment for benign prostatic hyperplasia (BPH) | Phase III trial initiated enrolling 1,000 male subjects with BPH who are also taking BPH medications but continue experiencing OAB symptoms |
| Breath Therapeutics | L CsA i | Bronchiolitis Obliterans Syndrome (BOS) | Phase III trial initiated enrolling 110 subjects with BOS following single lung (BOSTON-1) or double lung (BOSTON-2) transplantation at leading lung transplant specialty centers in eight countries |
| Novocure | Tumor Treating Fields combined with paclitaxel | recurrent, platinum-resistant ovarian cancer | Phase III trial initiated enrolling 540 subjects |
| Eisai Co., Ltd. | BAN2401 | Alzheimer's disease | Phase III trial initiated enrolling 1,566 subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia (collectively known as early AD) with confirmed amyloid pathology in the brain |
| Zimmer Biomet, Inc. | ROSA ONE Spine System | minimally invasive and complex spine surgeries | 510(k) clearance granted by the FDA |
| Genetesis, Inc. | CardioFlux | cardiac imaging | 510(k) clearance granted by the FDA |
| Beckman Coulter | DxH 520 hematology analyzer | neonate, pediatric and critical care | 510(k) clearance granted by the FDA |
| Enzyvant | RVT-801 | Farber disease | Rare Pediatric Disease designation granted by the FDA |
| Promedior, Inc. | PRM-151 | Idiopathic Pulmonary Fibrosis (IPF) | Breakthrough Therapy designation granted by the FDA |
| Impulse Dynamics | Optimizer Smart System for delivering CCM therapy | heart failure | Breakthrough Device designation granted by the FDA |
| Lipella Pharmaceuticals, Inc. | LP-10 | cancer survivors with hemorrhagic cystitis resulting from pelvic radiation therapy and/or systemic chemotherapy | IND approval granted by the FDA |
| Slayback Pharma LLC | Hydroxyprogesterone Ca-proate Injection, USP 250 mg/ 1 ml | preterm birth prevention | ANDA approval granted by the FDA |
| Enzyvant | RVT-801 | Farber disease | Fast Track approval granted by the FDA |
| Novartis | Mayzent (siponimod) | multiple sclerosis (MS) | Fast Track approval granted by the FDA |
| BrightWater Medical, Inc. | ConvertX Biliary Stent System | biliary obstructions | Approval granted by the FDA |
| Jazz Pharmaceuticals | Sunosi | narcolepsy | Approval granted by the FDA |
