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Pipeline
February 18, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| ADC Therapeutics | ADCT-402 (loncastuximab tesirine) plus AstraZeneca's IMFINZI (durvalumab) | advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL) | Phase I trial initiated enrolling 75 subjects |
| Exelixis, Inc. | XL092 | cancer | Phase I trial initiated |
| ReGenTree, LLC and Ora, Inc. | RGN-259 | dry eye syndrome | Phase III trial initiated enrolling 700 subjects |
| LASEROPTEK Co., Ltd. | PicoLO picosecond Nd:YAG laser | dermatology and general and plastic surgery | 510(k) clearance granted by the FDA |
| Grifols, S.A. | Procleix Babesia assay | blood screening | 510(k) clearance granted by the FDA |
| Finch Therapeutics Group, Inc. | CP101 | recurrent Clostridium difficile (C. difficile) infection | Breakthrough Therapy designation granted by the FDA |
| RDD Pharma, Inc. | RDD-0315 | fecal incontinence in spinal cord injury | Fast Track designation granted by the FDA |
| Neurotech Pharmaceuticals, Inc. | NT-501 (Renexus) | macular telangiectasia type 2 (MacTel) | Fast Track designation granted by the FDA |
| IntraBio, Inc. | IB1001 | GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease) | IND approval granted by the FDA |
| Pulmatrix, Inc. | Pulmazole (PUR1900) | allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma | IND approval granted by the FDA |
| Precigen, Inc. | PRGN-3005 | advanced-stage platinum-resistant ovarian cancer | IND approval granted by the FDA |
| Janssen Pharmaceutical Companies of Johnson & Johnson | Darzalex (daratumumab) split-dosing regimen | multiple myeloma | BLA approval granted by the FDA |
| Sanofi | Cablivi (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression | acquired thrombotic thrombocytopenic purpura (aTTP) in adults | BLA approval granted by the FDA |
| Medtronic | expanded indication for Pipeline Flex embolization device | brain aneurysm | Approval granted by the FDA |
| Orthofix Medical, Inc. | M6-C artificial cervical disc | cervical disc degeneration | Approval granted by the FDA |
