New Pipeline Updates from Agfa, Eisai and Axilum Robotics

March 4, 2019

Company Drug/Device Medical Condition Status
Phoenix Tissue Repair, Inc. PTR-01 recessive DEB (RDEB) Phase I/II trial initiated enrolling 14 subjects
Immunic AG IMU-838 relapsing-remitting multiple sclerosis (RRMS) Phase II trial initiated enrolling 200 subjects in more than 40 centers across four European countries
Debiopharm International SA afabicin (Debio 1450) staphylococcal bone and joint infections (NCT03723551) Phase II trial initiated enrolling 60 subjects with bone or joint infection (BJI)
Mycovia Pharmaceuticals VT-1161 recurrent vulvovaginal candidiasis (RVVC) Phase III trial initiated enrolling 180 subjects in 45 sites in the U.S.
Axilum Robotics TMS-Cobot TS MV Transcranial Magnetic Stimulation (TMS) for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode 510(k) clearance granted by the FDA
Agfa DR 800 multipurpose imaging system with tomosynthesis radiography, fluoroscopy, tomography and advanced clinical applications 510(k) clearance granted by the FDA
Imbrium Therapeutics L.P. and Mundipharma EDO GmbH etoposide toniribate relapsed refractory biliary tract cancer Orphan Drug designation granted by the FDA
Heron Therapeutics, Inc. CINVANTI (aprepitant) injectable emulsion intravenous (IV) use sNDA approval granted by the FDA
Eisai, Inc. labeling update for BELVIQ (lorcaserin HCl) obesity sNDA approval granted by the FDA
Alkermes plc and Biogen, Inc. diroximel fumarate (BIIB098) Multiple Sclerosis (MS) NDA approval granted by the FDA
Taiho Oncology LONSURF (trifluridine/tipiracil) adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neutargeted therapy Approval granted by the FDA
Spirosure, Inc. Fenom Pro asthma Clearance granted by the FDA
Bausch + Lomb LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% postoperative inflammation and pain following ocular surgery Approval granted by the FDA
BIOTRONIK Orsiro drug-eluting stent (DES) system coronary artery disease Approval granted by the FDA