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Pipeline

New Pipeline from BioSight,Vidac Pharma, Zebra Medical Vision and Kolon TissueGene

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