Pipeline

January 7, 2019

Company	Drug/Device	Medical Condition	Status
Pfizer, Inc.	PF-06651600 (oral JAK3 inhibitor)	moderate to severe alopecia areata	Phase II/III trial initiated enrolling 660 subjects
Slayback Pharma LLC	Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml	risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth	ANDA approval granted by the FDA
I-Mab Biopharma	TJM2, a humanized immunoglobulin G1 (IgG1) targeting granulocyte-macrophage colony-stimulating factor (GM-CSF)	autoimmune and inflammatory diseases	IND approval granted by the FDA
Cardiva Medical, Inc.	VASCADE MVP Venous Vascular Closure System	electrophysiology procedures	PMA approval granted by the FDA
Eiger BioPharmaceuticals, Inc.	lonafarnib	hepatitis delta virus (HDV) infection	PRIME (PRIority MEdicines) designation granted by the EMA
Horizon Pharma plc	RAVICTI (glycerol phenylbutyrate) Oral Liquid	infants younger than two months of age living with a urea cycle disorder (UCD)	sNDA approval granted by the FDA
Edwards Lifesciences Corporation	SAPIEN 3 Ultra system	transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery	Approval granted by the FDA
Sanofi and Merck	Vaxelis (ready-to-use hexavalent vaccine)	prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenza type b	Approval granted by the FDA
Alexion Pharmaceuticals	Ultomiris	paroxysmal nocturnal hemoglobinuria (PNH)	Approval granted by the FDA
Stemline Therapeutics	Elzonris	blastic plasmacytoid dendritic cell neoplasm (BPDCN)	Approval granted by the FDA
Teva Pharmaceutical Industries Ltd.	ProAir Digihaler (albuterol sulfate 117 mcg) inhalation powder	asthma and COPD	Approval granted by the FDA
Acorda	Inbrija	intermittent treatment of OFF episodes in Parkinson’s disease patients taking Carbidopa/Levodopa	Approval granted by the FDA
Merck	KEYTRUDA	recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)	Approval granted by the FDA
Veloxis Pharmaceuticals	Envarsus XR (tacrolimus extended-release tablets)	organ rejection in kidney transplant patients	Approval granted by the FDA
AstraZeneca and Merck	LYNPARZA	deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer	Approval granted by the FDA
Medtronic plc	InterStim smart programmer	overactive bladder (OAB), chronic fecal incontinence (FI) and non-obstructive urinary retention	Approval granted by the FDA
Celltrion, Inc. and Teva Pharmaceuticals Industries Limited	HERZUMA (trastuzumab-pkrb)	treatment of HER2-overexpressing breast cancer for certain indications	Approval granted by the FDA