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Home » Pipeline

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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