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Pipeline
July 16, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| OncoNano Medicine | ONM-100 intraoperative imaging agent | tumor acidosis for the detection of solid tumors | Phase I trial initiated enrolling subjects in The Netherlands |
| BELLUS Health Inc. | BLU-5937 | chronic cough | Phase I trial initiated enrolling 90 subjects in the U.S. |
| Aeromics, Inc. | AER-271 | cerebral edema | Phase I trial initiated enrolling 78 healthy subjects in the U.S. |
| Tetra Discovery Partners | BPN14770 | Fragile X Syndrome | Phase II trial initiated enrolling 30 adult male subjects, ages 18-45 years, in the U.S. |
| BioSight Ltd. | BST-236 | Newly-diagnosed Acute Myeloid Leukemia (AML) patients, either de novo or secondary to myelodys-plastic disorder (MDS) who are unfit for standard chemotherapy due to its severe toxicity | Phase IIb trial initiated enrolling subjects in 25 medical centers in the U.S. and Israel |
| Vidac Pharma | VDA-1102 | Actinic Keratosis (AK) | Phase IIb trial initiated enrolling 150 subjects in the U.S. |
| Citius Pharmaceuticals, Inc. | Mino-Lok therapy in combination with systemic antibiotics | Catheter Related Bloodstream Infections (CRBSIs) | Phase III trial initiated enrolling 700 subjects in the U.S. |
| Kolon TissueGene, Inc. | Invossa | knee osteoarthritis (OA) | Phase III trial initiated enrolling 1,020 subjects in the U.S. |
| Recursion | REC-994 | cerebral cavernous malformation (CCM) | IND clearance granted by the FDA |
| Adagene, Inc. | ADG-106 | advanced solid tumors and non-Hodgkin lymphoma | IND clearance granted by the FDA |
| Bausch + Lomb | Loteprednol etabonate ophthalmic gel | management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate | NDA approval granted by the FDA |
| Zebra Medical Vision | Coronary Calcium Scoring algorithm | coronary artery disease (CAD) | 510(k) clearance granted by the FDA |
| OCULOCARE medical Inc. | Alleye | mobile medical software application indicated for the detection and monitoring of age-related macular degeneration (AMD) | 510(k) clearance granted by the FDA |
| Eagle Pharmaceuticals, Inc. | BENDEKA (bendamustine hydrochloride injection, or bendamustine HCI) | chronic lymphocytic leukemia | Orphan Drug Exclusivity (ODE) granted by the FDA |
| OBI Pharma Inc. | OBI-3424 | Treatment of Hepatocellular Carcinoma (HCC) | Orphan Drug Designation granted by the FDA |
| US WorldMeds, LLC | LUCEMYRA (lofexidine) tablets | First non-opioid medication indicated for mitigation of opioid with-drawal symptoms to facilitate abrupt opioid discontinuation in adults |
Approval granted by the FDA |
