Pipeline

May 14, 2018

Company	Drug/Device	Medical Condition	Status
Nektar Therapeutics	NKTR-358	systemic lupus erythematosus (SLE)	Phase Ib trial initiated evaluating 50 subjects
Bonti, Inc.	EB-001T	elective abdominoplasty surgery	Phase II trial initiated
Amneal	IPX203	advanced Parkinson’s disease	Phase III trial initiated to enroll 500 subjects
Prisyna, the oral care division of Synedgen	Moisyn product line	xerostomia	510(k) clearance granted by the FDA
C4 Imaging LLC	HDR MRI Marker	use prior to high dose rate (HDR) brachytherapy to accurately locate the position of the applicators that guide the placement of radioactive sources for the treatment of multiple cancers	510(k) clearance granted by the FDA
Palladio Biosciences. Inc.	lixivaptan capsules	autosomal dominant polycystic kidney disease (ADPKD)	IND clearance granted by the FDA
Portola Pharmaceuticals	Andexxa	antidote for blood thinners rivaroxaban and apixaban	Approval granted by the FDA
Janssen Pharmaceutical Companies of Johnson & Johnson	DARZALEX (daratumumab) in combination with VELCADE (bortezomib), a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone - VMP	newly-diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT)	Approval granted by the FDA
PaxVax, Inc.	Chikungunya vaccine	prevention of the chikungunya virus	Fast Track Designation granted by the FDA
Debiopharm International SA	Debio 1347 (FGFR 1-3 Inhibitor)	unresectable or metastatic tumors with a specific FGFR gene alteration	Fast Track Designation granted by the FDA
Genentech	Tecentriq triple combination with Avastain (bevacizumab), paclitaxel and carboplatin (chemotherapy)	first-line treatement of patients with metastatic non-squamous non-small cell lung cancer (NSCLC)	Priority Review granted by the FDA