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Pipeline
August 6, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Clover Biopharmaceuticals, Inc. | SCB-808 | rheumatoid arthritis (RA) and other autoimmune diseases | Phase I trial initiated |
| Arcus Biosciences, Inc. | AB154 | anti-TIGIT antibody | Phase I trial initiated |
| CeraPedics | P-15L Peptide Enhanced Bone Graft | transforaminal lumbar interbody fusion (TLIF) surgery | Phase I trial initiated enrolling 364 subjects |
| BioLineRx Ltd. | AGI-134 | patient-specific tumor neoantigens | Phase I/IIa trial initiated |
| Avelas BioSciences, Inc. | AVB-620 | primary, non-recurrent breast cancer undergoing surgery | Period II, Phase II trial initiated enrolling 31 subjects |
| Biohaven Pharmaceutical Holding Company, Ltd. | trigriluzole (BHV-4157) | mild-to-moderate Alzheimer’s disease (AD) | Phase II/III trial initiated enrolling 292 subjects |
| Kala Pharmaceuticals, Inc. | KPI-121 0.25% | dry eye disease | Phase III trial initiated enrolling 900 subjects |
| GE Healthcare and Lantheus Holdings, Inc. | Flurpiridax | coronary artery disease | Phase III trial initiated enrolling 650 subjects |
| Progenics Pharmaceuticals | Azedra | adult and pediatric subjects 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy | NDA approval granted by the FDA |
| United Therapeutics Corporation | Remodulin | pulmonary arterial hypertension (PAH) | NDA approval granted by the FDA |
| Sensus Healthcare, Inc. | SRT-100+ | non-melanoma skin cancer and keloids | 510(k) clearance granted by the FDA |
| Modulated Imaging | Clarifi Imaging System | peripheral vascular diseases, diabetic foot ulcers, burns, skin flaps and chronic wounds | 510(k) clearance granted by the FDA |
| Daiichi Sankyo Company, Ltd. | quizartinib | relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) | Breakthrough Therapy Designation granted by the FDA |
| Armagen Inc. | GT-184 | Mucopolysaccharidosis type IIIA (also known as Sanfilippo Syndrome A or MPS IIIA) | Orphan Drug Designation granted by the FDA |
| Endomag | Magtrace | breast cancer | PMA granted by the FDA |
| Hologic, Inc. | Panther Fusion GBS assay | Group B Streptococcus (GBS) | Clearance granted by the FDA |
| Shionogi & Co., Ltd. | Mulpleta (lusutrombopag) | thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure | Approval granted by the FDA |
| Roche | cobas | cervical cancer | Approval granted by the FDA |
| Indivior PLC | PERSERIS | schizophrenia | Approval granted by the FDA |
