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Pipeline
October 21, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| NeuClone | NeuLara | plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis | Phase 1 trial initiated enrolling 200 healthy subjects |
| Alder BioPharmaceuticals, Inc. | ALD1910 | Migraine | Phase 1 trial initiated enrolling 100 healthy subjects between the ages of 18 and 55 |
| Amphivena Therapeutics, Inc. | AMV564 | Tumors | Phase 1 trial initiated enrolling subjects in San Antonio, TX, MD Anderson Cancer Center and Peninsula Cancer Institute in Newport News, VA |
| Nektar Therapeutics | NKTR-255 | relapsed or refractory non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) | Phase 1 trial initiated enrolling 40 subjects |
| DiaMedica Therapeutics Inc. | DM199 | Chronic kidney disease | Phase 2 trial initiated enrolling 60 African American subjects with CKD caused by IgA nephropathy (IgAN) and hypertensive with CKD at 10 sites in the U.S. |
| PhaseBio Pharmaceuticals | PB2452 with low-dose aspirin | blood thinning | Phase 2b trial initiated enrolling 200 elderly subjects aged 50-80 |
| Diamyd Medical | Diamyd | Latent Autoimmune Diabetes in Adults (LADA) | Phase 2 trial initiated enrolling 15 subjects newly diagnosed with LADA not yet on insulin therapy at the Norwegian University of Science and Technology in Trondheim |
| Can-Fite BioPharma Ltd. | Namodenoson | Nonalcoholic steatohepatitis (NASH)/nonalcoholic fatty liver disease (NAFLD) | Phase 2 trial initiated enrolling 60 subjects with NAFLD with or without NASH |
| Denovo Bipharma LLC | DB102 | glioblastoma (GBM) in combination with radiation and temozolomide | Phase 2b trial initiated enrolling 200 patients with newly-diagnosed GBM |
| Boehringer Ingelheim | BI 1265162 | cystic fibrosis | Phase 2 trial initiated enrolling subjects with relapsed or refractory lymphoma at sites in the U.S. and Europe |
| Hope Biosciences | HB-adMSCs | Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy | Phase 1/2 trial initiated enrolling 24 subjects |
| Imbrium Therapeutics | IMB-115 | insomnia associated with alcohol cessation (IAAC) | Phase 2 trial initiated enrolling adults with moderate or severe alcohol use disorder (AUD) experiencing IAAC |
| Diffusion Pharmaceuticals | TSC | stroke | Phase 2 trial initiated enrolling 160 subjects at 23 hospitals in the Virginia and Los Angeles County |
| Amygdala Neurosciences | ANS-6637 | alcohol use disorder AUD) | Phase 2 trial initiated enrolling 81 treatment seeking subjects with at least moderate alcohol use disorder at three sites |
| Novavax Inc. | NanoFlu | Influenza | Phase 3 trial initiated enrolling 2,650 adult subjects aged 65 and over at 19 sites in the U.S. |
| Axsome Therapeutics, Inc. | AXS-05 | major depressive disorder (MDD) | Phase 3 trial initiated enrolling 300 subjects with moderate to severe MDD |
| SurgiMab | SGM-101 | colorectal cancer | Phase 3 trial initiated enrolling 300 subjects with colorectal cancer in ten clinical centers in Europe and the U.S. |
| AstraZeneca | DS-8201 | breast cancer | Priority review granted by the FDA |
| Akorn, Inc. | betamethasone dipropionate lotion USP (augmented) | inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses | ANDA approval granted by the FDA |
| Subtle Medical | SubtleMR | image processing to improve medical imaging | 510 (k) clearance granted by the FDA |
| Cleveland Diagnostics, Inc. | IsoPSA | prostate cancer diagnostic test | Breakthrough device designation granted by the FDA |
| Genentech, Inc. | Xofluza | influenza complications | Approval granted by the FDA |
| Noven Pharmaceuticals, Inc. | SECUADO transdermal drug delivery system | schizophrenia | Approval granted by the FDA |
| Janssen Pharmaceuticals | XARELTO (rivaroxaban) | blood clots | Approval granted by the FDA |
| Eli Lilly | Reyvow | migraines | Approval granted by the FDA |
