Pipeline

October 1, 2018
Company Drug/Device Medical Condition Status
Verastem Copiktra Leukemia Granted approval by the FDA
MT.DERM GmbH Exceed, microneedling device Facial wrinkles Granted clearance by the FDA
Cook Medical 5 mm diameter version of Zilver® PTX® Peripheral artery disease (PAD) Granted clearance by the FDA
Avita Medical RECELL® Autologous Cell Harvesting Device (RECELL® System) Severe thermal burns in patients 18 and older Granted clearance by the FDA
Cardurion Pharmaceuticals CRD-733, a Phosphodiesterase-9 (PDE-9) inhibitor Heart failure FDA has accepted Investigational New Drug Application (IND)
OBI Pharma, Inc. OBI-3424 Acute Lymphoblastic Leukemia (ALL) Granted Orphan Drug Designation by FDA
Alnylam Pharmaceuticals Givosiran Acute hepatic porphyrias (AHPs) Successful early Phase III clinical trial results announced
AstraZeneca Imfinzi (durvalumab) Non-small cell lung cancer (NSCLC) Phase III PACIFIC clinical trial found cut deaths by a third
Genentech Tecentriq plus chemotherapy Extensive-stage small cell lung cancer (ES-SCLC) Phase III trial showed treatment helped patients live significantly longer than chemo alone
Daiichi Sankyo Company, Ltd Trastuzumab deruxtecan (DS-8201) Previously-treated HER2 positive unresectable and/or metastatic breast cancer Initiated two Phase III trials
Aurinia Pharmaceuticals, Inc. Voclosporin added to background therapy of mycophenolate mofetil (MMF)/CellCept® Lupus nephritis (LN) Completed enrollment in AURORA Phase III clinical trial
Catabasis Pharmaceuticals, Inc. Edasalonexent Duchenne muscular dystrophy (DMD) Initiated Polaris DMD Phase III clinical trial
AstraZeneca Farxiga (dapagliflozin) Cardiovascular disease Positive Phase III clinical trial results announced
Alexion Pharmaceuticals, Inc. Soliris® (eculizumab) Anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica spectrum disorder (NMOSD) Positive topline results from the Phase III PREVENT announced

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