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Eighteen Drugs and Devices have Entered a New Trial Phase This Week

February 12, 2018

Company Drug/Device Medical Condition Status
Fibrocell Science FCX-013 moderate to severe localized scleroderma IND submitted to the FDA
Daiichi Sankyo U3-1402 metastatic or unresectable epidermal growth factor receptor-mutated non-small cell lung cancer Phase I trials initiated enrolling 60 subjects globally
Palatin Technologies PL-8177 ulcerative colitis and other inflammatory bowel diseases Phase I trials initiated enrolling 52 subjects
Phosplatin Therapeutics PT-112 relapsed or refractory multiple myeloma Phase I/II trials initiated
Gemphire gemcabene pediatric nonalcoholic fatty liver disease Phase IIa trials initiated enrolling 40 adolescent children between the ages of 12 and 17
OncBioMune Pharmaceuticals ProscaVax advanced prostate cancer Phase II trials initiated
Xcovery ensartinib (X-396) advanced malignant melanoma harboring alterations in ALK Phase II trials initiated
Endo International collagenase clostridium histolyticum cellulite Phase III trials initiated enrolling 840 women in the U.S.
Pharma Two B P2B001 early Parkinson’s disease Phase III trials initiated enrolling 525 subjects
Tessa Therapeutics T cell immunotherapy nasopharyngeal cancer Phase III trials initiated enrolling 35 subjects
GlaxoSmithKline Bexsero meningitis B vaccine Breakthrough Therapy designation granted by the FDA
Sage Therapeutics SAGE-217 major depressive disorder Breakthrough Therapy designation granted by the FDA
Zogenix ZX008 (low-dose fenfluramine) seizures associated with Dravet syndrome Breakthrough Therapy designation granted by the FDA
MeiraGTx AAV2/8-hCARp.hCNGB3 (A002) achromatopsia due to mutations in the CNGB3 gene Rare Pediatric Disease designation granted by the FDA
Adhesys Medical VIVO surgical sealant Expedited Access Pathway designation granted by the FDA
Alnylam Pharmaceuticals patisiran hereditary ATTR amyloidosis NDA accepted and Priority Review granted by the FDA
Allergan Avycaz (ceftazidime and avibactam) hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia Expanded use approved by the FDA
Ferring Pharmaceuticals Zomacton (somatropin) human growth hormone deficiency FDA approved