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Pipeline
July 23, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Blade Therapeutics | BLD-2660 | debilitating fibrotic diseases | Phase I trial initiated |
| SOM Biotech | SOM3355 | chorea movements associated with Huntington’s disease | Phase II trial initiated enrolling 30 subjects |
| Concentric Analgesics, Inc. | CA-008 | post-surgical pain | Phase II trial initiated |
| Ironwood Pharmaceuticals, Inc. | linaclotide | irritable bowel syndrome with constipation (IBS-C) | Phase IIIb trial initiated enrolling 600 adult IBS-C subjects in the U.S. |
| RDD Pharma | RDD-0315 | fecal incontinence in subjects with spinal cord injury | IND clearance granted by the FDA |
| MaxCyte | MCY-M11 (chimeric antigen receptor (CAR) therapeutic candidate) | solid tumors | IND clearance granted by the FDA |
| Stryker Corporation | Surpass Streamline Flow Diverter | unruptured large and giant wide neck intracranial aneurysms | PMA granted by the FDA |
| Astellas Pharma Inc. and Pfizer Inc. | XTANDI (enzalutamide) | castration-resistant prostate cancer, including men with non-metastatic CRPC | sNDA approval granted by the FDA |
| Adaptiiv | 3D Bolus Software | cancer | 510(k) clearance granted by the FDA |
| Zavation | Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage) | cervical spine (C2-C7) and thoracolumbar spine (T1-L5) for partial or total replacement of a diseased, collapsed, damaged or unstable vertebral body | 510(k) clearance granted by the FDA |
| Quidel Corporation | Solana Bordetella Complete Molecular Diagnostic Assay | detection of Pertussis (whooping cough) Parapertussis Infections | 510(k) clearance granted by the FDA |
| Genentech | TECENTRIQ (atezolizumab) in combination with Avastin (bevacizumab) | chronic lymphocytic leukemia | Breakthrough Therapy Designation granted by the FDA |
| Gamida Cell | NiCord | hematopoietic stem cell transplantation (HSCT) | Orphan Drug Designation granted by the FDA |
| Inozyme Pharma | INZ-701 | ENPP1 Deficiency (GACI in infants and ARHR2 post-infancy) | Orphan Drug Designation granted by the FDA |
| Vallum Corporation | polyetheretherketone (PEEK) spinal interbody fusion device | spinal fusion | Clearance granted by the FDA |
| SIGA Technologies Inc. and U.S. Department of Health and Human Services’ BARDA | TPOXX (tecovirimat) | smallpox | Approval granted by the FDA |
| Janssen Pharmaceutical Companies of Johnson & Johnson | SYMTUZA | darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults | Approval granted by the FDA |
