Pipeline

May 29, 2018

Company	Drug/Device	Medical Condition	Status
Pfizer Inc.	investigational RSV vaccine	respiratory syncytial virus (RSV)	Phase I/II trial initiated enrolling healthy adult volunteers in two age groups of 18-49 and 50-85
Acceleron Pharma Inc.	sotatercept	pulmonary arterial hypertension (PAH)	Phase II trial initiated enrolling 90 subjects
Nabriva Therapeutics	lefamulin	moderate community-acquired bacterial pneumonia (CABP)	Phase III trial topline results reported
Providence Medical Technology, Inc.	DTRAX Spinal System	posterior cervical fusion in patients with cervical degenerative disc disease	510(k) clearance granted by the FDA
CERENOVUS, part of the Johnson & Johnson Medical Devices Companies	EMBOTRAP II Revascularization Device	next generation stent retriever used to capture and remove life-threatening blood clots from the brain following an ischemic stroke	510(k) clearance granted by the FDA
Lannett Company, Inc.	Dronabinol Capsules	HIV	aNDA approval granted by the FDA
AcelRx Pharmaceuticals, Inc.	DSUVIA	moderate-to-severe acute pain for adult patients in medically supervised settings	NDA approval granted by the FDA
Amgen and Novartis	Aimovig (erenumab-aooe)	preventative treatment of migraine in adults	Approval granted by the FDA
Nestlé Skin Health	hyaluronic acid (HA) dermal filler Restylane Lyft	correction of age-related volume loss in the back of the hands for patients over the age of 21	Approval granted by the FDA
AstraZeneca	Lokelma (sodium zirconium cyclosilicate)	treatment of adults with hyperkalemia	Approval granted by the FDA
Sun Pharmaceutical Industries Ltd. and Churchill Pharmaceuticals, LLC	YONSA (abiraterone acetate) in combination with methylprednisolone	metastatic castration-resistant prostate cancer (mCRPC)	Approval granted by the FDA
Abbott	XIENCE Sierra	coronary artery diseasen	Approval granted by the FDA
Janssen	JULUCA (dolutegravir/rilpivirine)	two-drug regimen, once-daily, single-pill for the treatment of human immunodeficiency virus type 1 (HIV-1) infection	Approval granted by the EMA
WAT Medical	EmeTerm	nausea-induced vomiting	Clearance granted by the FDA
UTILITY therapeutics Ltd	mecillinam (injectable) and pivmecillinam (oral prodrug)	complicated urinary tract infections (cUTI)	QIDP Designation granted by the FDA
Harmony Biosciences, LLC	pitolisant	cataplexy in patients with narcolepsy	Breakthrough Therapy Designation granted by the FDA
bluebird bio, Inc.	Lenti-D	cerebral adrenoleukodystrophy (CALD)	Breakthrough Therapy Designation granted by the FDA
Harmony Biosciences, LLC	pitolisant	excessive daytime sleepiness in patients with narcolepsy	Fast Track Designation granted by the FDA
Berg, LLC	BPM 31510 (ubidecarenone)	Epidermolysis Bullosa (EB)	Orphan Drug Designation granted by the FDA