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

 

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