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Pipeline
March 4, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Phoenix Tissue Repair, Inc. | PTR-01 | recessive DEB (RDEB) | Phase I/II trial initiated enrolling 14 subjects |
| Immunic AG | IMU-838 | relapsing-remitting multiple sclerosis (RRMS) | Phase II trial initiated enrolling 200 subjects in more than 40 centers across four European countries |
| Debiopharm International SA | afabicin (Debio 1450) | staphylococcal bone and joint infections (NCT03723551) | Phase II trial initiated enrolling 60 subjects with bone or joint infection (BJI) |
| Mycovia Pharmaceuticals | VT-1161 | recurrent vulvovaginal candidiasis (RVVC) | Phase III trial initiated enrolling 180 subjects in 45 sites in the U.S. |
| Axilum Robotics | TMS-Cobot TS MV | Transcranial Magnetic Stimulation (TMS) for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode | 510(k) clearance granted by the FDA |
| Agfa | DR 800 multipurpose imaging system with tomosynthesis | radiography, fluoroscopy, tomography and advanced clinical applications | 510(k) clearance granted by the FDA |
| Imbrium Therapeutics L.P. and Mundipharma EDO GmbH | etoposide toniribate | relapsed refractory biliary tract cancer | Orphan Drug designation granted by the FDA |
| Heron Therapeutics, Inc. | CINVANTI (aprepitant) injectable emulsion | intravenous (IV) use | sNDA approval granted by the FDA |
| Eisai, Inc. | labeling update for BELVIQ (lorcaserin HCl) | obesity | sNDA approval granted by the FDA |
| Alkermes plc and Biogen, Inc. | diroximel fumarate (BIIB098) | Multiple Sclerosis (MS) | NDA approval granted by the FDA |
| Taiho Oncology | LONSURF (trifluridine/tipiracil) | adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neutargeted therapy | Approval granted by the FDA |
| Spirosure, Inc. | Fenom Pro | asthma | Clearance granted by the FDA |
| Bausch + Lomb | LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% | postoperative inflammation and pain following ocular surgery | Approval granted by the FDA |
| BIOTRONIK | Orsiro drug-eluting stent (DES) system | coronary artery disease | Approval granted by the FDA |
