Pipeline

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