Home » Pipeline
Pipeline
March 18, 2019
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Rocket Pharmaceuticals, Inc. | RP-L102 | Fanconi Anemia (FA) | Phase I trial initiated enrolling 2 FA pediatric subjects |
Infinity Pharmaceuticals, Inc. | IPI-549 | triple negative breast cancer (TNBC) and renal cell cancer (RCC) | Phase II trial initiated |
Theravance Biopharma, Inc. | TD-1473 | moderately to severely active ulcerative colitis | Phase IIb/III trial initiated |
Biohaven Pharmaceutical Holding Company Ltd. | troriluzole | Spinocerebellar Ataxia (SCA) | Phase III trial initiated enrolling 230 subjects at approximately 22 sites in the U.S. |
Alvotech | AVT02 | moderate to severe chronic plaque psoriasis | Phase III trial initiated enrolling 400 subjects at approximately 30 sites in Europe |
Helsinn Group | anamorelin | advanced NSCLC with cachexia | Phase III trial initiated |
Santhera Pharmaceuticals AG | Raxone | Leber’s hereditary optic neuropathy (LHON) | Phase IV trial initiated enrolling 197 subjects in 31 sites across nine European countries and the U.S. |
Nvision Biomedical Technologies | Vector Hammertoe Correction System | foot and ankle procedures | 510(k) clearance granted by the FDA |
Sonavex, Inc. | EchoSure | blood flow monitoring | 510(k) clearance granted by the FDA |
Instrumentation Laboratory | GEM Premier ChemSTAT in vitro diagnostic (IVD) analyzer with Intelligent Quality Management (iQM) | rapid basic metabolic panel (BMP) testing at the point of care for diagnosing acute conditions, such as kidney failure, insulin shock, respiratory distress and arrhythmias | 510(k) clearance granted by the FDA |
Purdue Pharma L.P. | nalmefene hydrochloride (HCl) injection | emergency treatment of known or suspected opioid overdose | Fast Track designation granted by the FDA |
Alkem Laboratories Limited | Valsartan (generic Diovan) | high blood pressure and heart failure | Approval granted by the FDA |
Aerie Pharmaceuticals, Inc. | Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% | open-angle glaucoma or ocular hypertension | Approval granted by the FDA |
Genentech | Tecentriq (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albuminbound); nab-paclitaxel]) | unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test | Approval granted by the FDA |
Pfizer, Inc. | TRAZIMERA (trastuzumab-qyyp) | human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma | Approval granted by the FDA |
Upcoming Events
-
21Oct