Pipeline

July 2, 2018
Company Drug/Device Medical Condition Status
Oramed Pharmaceuticals Inc. ORMD-0801 type 1 diabetes Phase I trial initiated
Erimos Pharmaceuticals, LLC terameprocol (EM-1421) High Grade Glioma (Grade III or IV) Phase I trial initiated
BioGend Therapeutics one-step autologous knee cartilage repair/regeneration repair treatment for knee chondral or osteochondral defects Phase I trial initiated enrolling 92 subjects
Rigel Pharmaceuticals, Inc. R835 (IRAK1/4 inhibitor) autoimmune and inflammatory diseases Phase I trial initiated enrolling 91 subjects
Navitor Pharmaceuticals, Inc. NV-5138 treatment-resistant depression (TRD) Phase I trial initiated enrolling 88 subjects
Axonics Modulation Technologies, Inc. rechargeable Sacral Neuromodulation (r-SNM) System urinary and bowel disfunction Phase I trial initiated enrolling 120 subjects
BioAtla, LLC BA3021 (CAB-ROR2-ADC therapeutic) advanced solid tumors including non-small cell lung cancer (NSCLC), triple negative breast cancer and soft tissue sarcoma Phase I/II trial initiated
Roche and Genentech TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and etoposide) Extensive-stage small cell lung cancer (ES-SCLC) Phase III trial initiated enrolling 403 subjects in the U.S.
Beckman Coulter Diagnostics Access hsTnl (high-sensitivity troponin assay) myocardial infarction 510(k) Clearance granted by the FDA
Renovis Surgical Technologies, Inc. Tesera SA Hyperlordotic ALIF Interbody Spinal Fusion System spinal fusion 510(k) Clearance granted by the FDA
Genentech Baloxavir marboxil single-dose oral flu treatment for people 12 years and older Priority Review and NDA approval granted by the FDA
Merck & Company KEYTRUDA (pembrolizumab) adjuvant therapy in advanced melanoma sBLA accepted by the FDA
Glaukos Corporation iStent inject Trabecular Micro-Bypass System reduction of intraocular pressure (IOP) in adult mild-to-moderate primary open-angle glaucoma (POAG) patients undergoing concomitant cataract surgery Approval granted by the FDA
Ferring Pharmaceuticals Inc. NOCDURNA (desmopressin acetate) treatment of nocturne due to nocturnal polyuria in adults who awaken at least two times per night to void Approval granted by the FDA
Achaogen Zemdri (plazomicin) complicated urinary tract infection Approval granted by the FDA
Array BioPharma, Inc. Braftovi + Mektovi BRAF-mutant metastatic melanoma Approval granted by the FDA
Processa Pharmaceuticals, Inc. PCS499 Necrobiosis Lipoidica (NL) Orphan Drug Designation granted by the FDA

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