Pipeline

June 11, 2018
Company Drug/Device Medical Condition Status
Peloton Therapeutics, Inc. PT2977 (oral HIF-2α inhibitor) Treatment of von Hippel-Linau (VHL) disease-associated kidney cancer Phase II trial initiated enrolling 50 subjects in the U.S.
Viking Therapeutics, Inc. VK2809 Primary hypercholesterolemia and non-alcoholic fatty liver desease (NAFLD) Phase II trial initiated
Tricida, Inc. TRCA-301 chronic kidney disease patients with metabolic acidosis Phase III trial initiated enrolling 217 subjects in the U.S. and Europe
Janssen (part of Johnson & Johnson) esketamine nasal spray adults with treatment-resistant depression Phase III trial initiated
Camber Spine Technologies ENZA (Titanium Anterior Lumbar Interbody Fusion (ALIF) system autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 510(k) clearance granted by the FDA
Royal Philips Ingenia Elition 3.0T MR solution increased diagnostic performance 510(k) clearance granted by the FDA
Partner Therapeutics, Inc. Leukine adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrom of Acute Radiation Syndrome) Approval granted by the FDA
Mylan Fulphila (pegfilgrastim-jmbd) febrile neutropenia Approval granted by the FDA
Eli Lilly and Incyte Corporation OLUMIANT (baricitnib) adults with moderately-to-severely active Rheumatoid Arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies Approval granted by the FDA
Micronics, Inc. PanNAT STEC Test Shiga toxin-producing E. Coli (STEC) Clearance granted by the FDA
Chugai Pharmaceutical Co., Ltd. HEMLIBRA (U.S. generic name: emicizumab-kxwh) adults and children with hemophilia A without factor VIII inhibitors Priority Review Designation granted by the FDA
Pfizer Talazoparib germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC) Priority Review Designation granted by the FDA
Pfizer Xalkori (crizotinib) relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive Breakthrough Therapy Designation granted by the FDA
AutoGenomics, Inc. INFINITI Neutral Response Panel opioid dependency Breakthrough Device Designation granted by the FDA
Curis, Inc. fimepinostat (CUDC-907) relapsed or fractory (R/R) diffuse large B-cell lymphoma (DLBCL) Fast Track Designation granted by the FDA
Alnylam Pharmaceuticals, Inc. ALN-TTRsc02 Transthyretin-mediated amyloidosis Orphan Drug Designation granted by the FDA

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