Pipeline new from Genentech, UCB, Pfizer, and Faxitron

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