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Pipeline
July 2, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Oramed Pharmaceuticals Inc. | ORMD-0801 | type 1 diabetes | Phase I trial initiated |
| Erimos Pharmaceuticals, LLC | terameprocol (EM-1421) | High Grade Glioma (Grade III or IV) | Phase I trial initiated |
| BioGend Therapeutics | one-step autologous knee cartilage repair/regeneration | repair treatment for knee chondral or osteochondral defects | Phase I trial initiated enrolling 92 subjects |
| Rigel Pharmaceuticals, Inc. | R835 (IRAK1/4 inhibitor) | autoimmune and inflammatory diseases | Phase I trial initiated enrolling 91 subjects |
| Navitor Pharmaceuticals, Inc. | NV-5138 | treatment-resistant depression (TRD) | Phase I trial initiated enrolling 88 subjects |
| Axonics Modulation Technologies, Inc. | rechargeable Sacral Neuromodulation (r-SNM) System | urinary and bowel disfunction | Phase I trial initiated enrolling 120 subjects |
| BioAtla, LLC | BA3021 (CAB-ROR2-ADC therapeutic) | advanced solid tumors including non-small cell lung cancer (NSCLC), triple negative breast cancer and soft tissue sarcoma | Phase I/II trial initiated |
| Roche and Genentech | TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and etoposide) | Extensive-stage small cell lung cancer (ES-SCLC) | Phase III trial initiated enrolling 403 subjects in the U.S. |
| Beckman Coulter Diagnostics | Access hsTnl (high-sensitivity troponin assay) | myocardial infarction | 510(k) Clearance granted by the FDA |
| Renovis Surgical Technologies, Inc. | Tesera SA Hyperlordotic ALIF Interbody Spinal Fusion System | spinal fusion | 510(k) Clearance granted by the FDA |
| Genentech | Baloxavir marboxil | single-dose oral flu treatment for people 12 years and older | Priority Review and NDA approval granted by the FDA |
| Merck & Company | KEYTRUDA (pembrolizumab) | adjuvant therapy in advanced melanoma | sBLA accepted by the FDA |
| Glaukos Corporation | iStent inject Trabecular Micro-Bypass System | reduction of intraocular pressure (IOP) in adult mild-to-moderate primary open-angle glaucoma (POAG) patients undergoing concomitant cataract surgery | Approval granted by the FDA |
| Ferring Pharmaceuticals Inc. | NOCDURNA (desmopressin acetate) | treatment of nocturne due to nocturnal polyuria in adults who awaken at least two times per night to void | Approval granted by the FDA |
| Achaogen | Zemdri (plazomicin) | complicated urinary tract infection | Approval granted by the FDA |
| Array BioPharma, Inc. | Braftovi + Mektovi | BRAF-mutant metastatic melanoma | Approval granted by the FDA |
| Processa Pharmaceuticals, Inc. | PCS499 | Necrobiosis Lipoidica (NL) | Orphan Drug Designation granted by the FDA |
