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Pipeline
November 24, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| CStone Pharmaceuticals | ivosidenib | relapsed or refractory acute myeloid leukemia | Phase 1 trial initiated enrolling subjects with IDH1 mutant relapsed or refractory acute myeloid leukemia (R/R AML) |
| Seelos Therapeutics, Inc. | SLS-002 | Central Nervous System (CNS) disorders and rare diseases | Phase 1 trial initiated enrolling 48 healthy volunteers |
| Spring Bank Pharmaceuticals, Inc. | SB 11285 | advanced solid tumors | Phase 1 trial initiated at multiple sites in the U.S. |
| Celldex Therapeutics, Inc. | CDX-0159 | chronic idiopathic urticaria (CIU) | Phase 1a trial initiated enrolling 32 healthy subjects |
| Medivir AB | MIV-818 | liver cancer | Phase 1a trial initiated enrolling nine subjects with advanced liver cancer |
| Enlivex Therapeutics Ltd. | Allocetra | severe sepsis | Phase 1b trial initiated enrolling 10 subjects |
| Phoenix Molecular Designs | PMD-026 | triple negative breast cancer | Phase 1/1b trial initiated enrolling subjects with metastatic breast cancer and triple negative breast cancer at sites in the U.S. |
| Sensei Biotherapeutics | SNS-301 in combination with pembrolizumab | ASPH positive head and neck cancer | Phase 1/2 trial initiated enrolling 30 subjects |
| Axial Biotherapeutics | AB-2004 | Autism Spectrum Disorder (ASD) | Phase 1b/2a trial initiated enrolling 25 male adolescent subjects |
| Inotrem S.A. | nangibotide | septic shock | Phase 2b trial initiated enrolling 450 subjects with septic shock at 48 sites across five countries in Europe and the U.S. |
| Viking Therapeutics | VK2809 | non-alcoholic steatohepatitis | Phase 2b trial initiated enrolling 340 subjects with biopsy-confirmed NASH and fibrosis ranging from stages F1 to F3 at multiple sites |
| BiondVax Pharmaceuticals Ltd. | M-001 | universal flu vaccine | Phase 3 trial initiated enrolling 12,463 subjects ages 50 years and older, including 6,291 ages 65 and older at 83 sites in eastern European countries |
| Achillion Pharmaceuticals, Inc. | danicopan (ACH-4471) | paroxysmal nocturnal hemoglobinuria (PNH) in patients who are not adequately responding to a C5 inhibitor | PRIME Designation granted by the EMA |
| Carestream | Focus 35C Detector with Image Suite Software | medical imaging | 510(k) Clearance Granted by the FDA |
| Merit Medical Systems, Inc. | WRAPSODY | stenosis within the central veins of the outflow circuit of an arteriovenous fistula (AVF) up to the superior vena cava | Breakthrough Device Designation granted by the FDA |
| Siemens Healthineers | SOMATOM X.cite | single-source computed tomography (CT) scanner | Clearance granted by the FDA |
| AstraZeneca | Calquence | chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) | Supplemental Approval granted by the FDA |
| BeiGene | BRUKINSA (zanubrutinib) | mantle cell lymphoma (MCL) | Accelerated Approval granted by the FDA |
| CooperVision | MiSight 1day contact lens | myopia in children eight to 10 years of age | Approval granted by the FDA |
| Pfizer | Abrilada (adalimumab-afzb) | rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis | Approval granted by the FDA |
| CeraPedics, Inc. | i-FACTOR Peptide Enhanced Bone Graft | degenerative cervical disc disease | PMA Approval granted by the FDA |
| Novartis | Adakveo (crizanlizumab) | sickle cell disease | Approval granted by the FDA |
| Q Biomed Inc. | Strontium-89 | skeletal metastases caused by cancer | Approval granted by the FDA |
| Alnylam Pharamceuticals, Inc. | GIVLAARI (givosiran) injection | acute hepatic porphyria (AHP) | Approval granted by the FDA |
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