Pipeline

May 21, 2018

Company	Drug/Device	Medical Condition	Status
Entasis Therapeutics	ETX0282 and ETX0282CPDP (combination of ETX0282 with cefpodoxime)	Oral therapy for infections caused by multidrug-resistant (MDR) Gram-negative pathogens, including MDR and carbapenem-resistant Enterobacteriaceae (CRE)	Phase I trial initiated enrolling healthy subjects from Australia
BioMarin Pharmaceutical Inc.	Valoctocogene roxaparvovec	Hemophilia A patients with pre-existing AAV5 antibodies	Phase I/II trial initiated
Alkahest, Inc.	ALK4290 and ALK4290-201	newly-diagnosed wet age-related macular degeneration and refractory wet age-related macular degeneration, respectively	Phase II trials initiated
Regeneron Pharmaceuticals, Inc.and Sanofi	DUPIXENT (dupilumab)	moderate-to-severe atopic dermatitis in adolescents ages 12-17	Phase III trial initiated enrolling 251 subjects
MC10, Inc.	BioStamp nPoint system	data collection platform	510(k) clearance granted by the FDA
Caliber Imaging & Diagnostics Inc.	VIVASCOPE System	Reflectance confocal microscopy (RCM) devise	510(k) clearance granted by the FDA
CurveBeam	LineUP Multi-extremity weight bearing CT system	orthopedic extremity imaging	510(k) clearance granted by the FDA
Faxitron	VisionCT	fully enhances the clinician’s ability for detailed margin assessment by automatically taking images around the entire specimen and reconstructing a navigable 3D render in real time	510(k) clearance granted by the FDA
Turnstone Biologics	MG1-HPV	Human papillomavirus (HPV)-positive solid tumors	IND clearance granted by the FDA
Amneal Pharmaceuticals, Inc.	Generic Welchol (colesevelam HCI) 625 mg tablets	Cholesterol	aNDA approval granted by the FDA
US WorldMeds	Lucemyra (lofexidine hydrochloride)	mitigation of opioid withdrawl symptoms in adult	Approval granted by the FDA
Pfizer	Retacrit (epoetin alfaepbx)	biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy or the use of zidovudine in patients with HIV infection	Approval granted by the FDA
Genentech	Actemra	Active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age or older	Approval granted by the FDA
UCB	BRIVIACT (Brivaracetam)	monotherapy or adjuctive therapy in patients four years of age and older with partial-onset seizures	Approval granted by the FDA
BMG Pharma	GelX	oral mucositis	Approval granted by the EMA
Castle Creek Pharmaceuticals	diacerein 1% ointment (CCP-020)	Epidermolysis bullosa (EB)	Pediatric Disease Designation granted by the FDA
Immunicom, Inc.	Immunopheresis therapy	cancer tumors	Breakthrough Device Designation granted by the FDA