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Pipeline
February 25, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Ocular Therapeutix, Inc. | OTX-TKI (tyrosine kinase inhibitor implant) | wet Age-related Macular Degeneration (AMD) | Phase I trial initiated |
| Inhibrx, Inc. | INBRX-105 | PD-L1 expressing tumors | Phase I trial initiated |
| Fusion Pharmaceuticals | [225Ac]-FPI-1434 | advanced solid tumors | Phase I trial initiated enrolling up to 30 subjects |
| Five Prime Therapeutics, Inc. | FPA150 (FPA150-001; NCT03514121) | breast, ovarian and endometrial cancers that over-express B7-H4 | Phase Ib trial initiated |
| Advaxis, Inc. | ADXS-503 | non-small cell lung cancer (NSCLC) | Phase I/II trial initiated enrolling 50 subjects at up to 20 sites in the U.S. |
| Lipocine, Inc. | LPCN 1144 | non-alcoholic steatohepatitis ("NASH") with biopsy | Phase II trial initiated enrolling male hypogonadal biopsy-confirmed NASH subjects with grade F2/F3 fibrosis |
| Debiopharm International SA | Debio 1347 | solid tumors harboring an FGFR fusion (NCT03834220) | Phase II trial initiated enrolling subjects with advanced or metastatic tumors whose cells show specific FGFR gene alterations, namely FGFR1, FGFR2 or FGFR3 gene fusions |
| Novus Therapeutics, Inc. | OP0201 | otitis media | Phase IIa trial initiated enrolling 50 pediatric patients, 6 to 24 months of age, with acute otitis media |
| Biohaven Pharmaceutical Holding Company Ltd. | troriluzole | generalized anxiety disorder (GAD) | Phase III trial initiated enrolling 372 subjects in 50 sites in the U.S. |
| Biohaven Pharmaceutical Holding Company Ltd. | verdiperstat (previously BHV-3241) | multiple system atrophy (MSA) | Orphan Drug designation granted by the FDA |
| Ocugen, Inc. | OCU400 | NR2E3 mutation-associated retinal degenerative disease | Orphan Drug designation granted by the FDA |
| Modis Therapeutics | MT1621 | thymidine kinase 2 deficiency (TK2d) | Breakthrough Therapy designation granted by the FDA |
| Medtronic plc | Personalized Closed Loop (PCL) insulin pump system | diabetes | Breakthrough Device designation granted by the FDA |
| Fujirebio Diagnostics, Inc. | Lumipulse G β-Amyloid Ratio (1-42/1-40) quantitative in vitro diagnostic test | Alzheimer’s Disease | Breakthrough Device designation granted by the FDA |
| ARS Pharmaceuticals, Inc. | ARS-1 | severe allergic reactions that could lead to anaphylaxis | Fast Track designation granted by the FDA |
| Foldax, Inc. | Tria surgical aortic heart valve | aortic valve disease | IDE approval granted by the FDA |
| Genentech | polatuzumab vedotin in combination with bendamustine plus Rituxan (rituximab) (BR) | relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) | Priority Review granted by the FDA |
| Genentech | entrectinib | adult and pediatric subjects with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumors who have either progressed following prior therapies or as initial therapy when there are no acceptable standard therapies, and for the treatment of subjects with metastatic, ROS1-positive non-small cell lung cancer (NSCLC) | Priority Review granted by the FDA |
| Novo Nordisk | Esperoct (turoctocog alfa pegol) formerly known as N8-GP | hemophilia A | BLA approval granted by the FDA |
| Merck | KEYTRUDA (pembrolizumab) | adjuvant treatment of subjects with melanoma with involvement of lymph node(s) following complete resection | BLA approval granted by the FDA |
| Xellia Pharmaceuticals | Premixed Vancomycin Injection in a Ready-to-Use (RTU) bag | septicaemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections in adult and pediatric subjects (one month and older) | NDA approval granted by the FDA |
| Nexus Pharmaceuticals, Inc. | Prochlorperazine Edisylate Injection, USP | schizophrenia and severe nausea and vomiting | Approval granted by the FDA |
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