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Pipeline
May 29, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Pfizer Inc. | investigational RSV vaccine | respiratory syncytial virus (RSV) | Phase I/II trial initiated enrolling healthy adult volunteers in two age groups of 18-49 and 50-85 |
| Acceleron Pharma Inc. | sotatercept | pulmonary arterial hypertension (PAH) | Phase II trial initiated enrolling 90 subjects |
| Nabriva Therapeutics | lefamulin | moderate community-acquired bacterial pneumonia (CABP) | Phase III trial topline results reported |
| Providence Medical Technology, Inc. | DTRAX Spinal System | posterior cervical fusion in patients with cervical degenerative disc disease | 510(k) clearance granted by the FDA |
| CERENOVUS, part of the Johnson & Johnson Medical Devices Companies | EMBOTRAP II Revascularization Device | next generation stent retriever used to capture and remove life-threatening blood clots from the brain following an ischemic stroke | 510(k) clearance granted by the FDA |
| Lannett Company, Inc. | Dronabinol Capsules | HIV | aNDA approval granted by the FDA |
| AcelRx Pharmaceuticals, Inc. | DSUVIA | moderate-to-severe acute pain for adult patients in medically supervised settings | NDA approval granted by the FDA |
| Amgen and Novartis | Aimovig (erenumab-aooe) | preventative treatment of migraine in adults | Approval granted by the FDA |
| Nestlé Skin Health | hyaluronic acid (HA) dermal filler Restylane Lyft | correction of age-related volume loss in the back of the hands for patients over the age of 21 | Approval granted by the FDA |
| AstraZeneca | Lokelma (sodium zirconium cyclosilicate) | treatment of adults with hyperkalemia | Approval granted by the FDA |
| Sun Pharmaceutical Industries Ltd. and Churchill Pharmaceuticals, LLC | YONSA (abiraterone acetate) in combination with methylprednisolone | metastatic castration-resistant prostate cancer (mCRPC) | Approval granted by the FDA |
| Abbott | XIENCE Sierra | coronary artery diseasen | Approval granted by the FDA |
| Janssen | JULUCA (dolutegravir/rilpivirine) | two-drug regimen, once-daily, single-pill for the treatment of human immunodeficiency virus type 1 (HIV-1) infection | Approval granted by the EMA |
| WAT Medical | EmeTerm | nausea-induced vomiting | Clearance granted by the FDA |
| UTILITY therapeutics Ltd | mecillinam (injectable) and pivmecillinam (oral prodrug) | complicated urinary tract infections (cUTI) | QIDP Designation granted by the FDA |
| Harmony Biosciences, LLC | pitolisant | cataplexy in patients with narcolepsy | Breakthrough Therapy Designation granted by the FDA |
| bluebird bio, Inc. | Lenti-D | cerebral adrenoleukodystrophy (CALD) | Breakthrough Therapy Designation granted by the FDA |
| Harmony Biosciences, LLC | pitolisant | excessive daytime sleepiness in patients with narcolepsy | Fast Track Designation granted by the FDA |
| Berg, LLC | BPM 31510 (ubidecarenone) | Epidermolysis Bullosa (EB) | Orphan Drug Designation granted by the FDA |
