New Pipeline Updates from Pfizer, Immusoft, Allergan and UCB

October 22, 2018

Company Drug/Device Medical Condition Status
Viseon, Inc. Voyant System, featuring proprietary HD imaging sensor and illumination technology Minimally invasive spine surgery Granted 510(k) clearance by the FDA
Centric Medical SATURN External Fixation System which consists of rings, struts, threaded rods, pins, wires and connectors To stabilize the foot, ankle and long bone segments Granted 510(k) clearance by the FDA
Pfizer PARP inhibitor, Talzenna (talazoparib) BRCA-mutated (gBRCAm), HER2-negative breast cancer Granted approval by the FDA
Abireo Pharma, Inc. A4250 Progressive familial intrahepatic cholestasis (PFIC) Granted Fast Track designation by the FDA
Immusoft Corp. Iduronicrin genleukocel-T Mucopolysaccharidosis type I (MPS I) Granted Rare Pediatric Disease designation (RPDD) by the FDA
Cellenkos, Inc. CK0801 Treatment-resistant Guillain-Barré Syndrome (GBS) FDA has cleared its Investigational New Drug (IND) application to proceed with a Phase I clinical trial
Allergan, plc and Medicines360 LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg Prevention of pregnancy for up to five years FDA approved Supplemental New Drug Application (sNDA) to extend the duration of use
AstraZeneca and Merck LYNPARZA Pancreatic cancer Granted Orphan Drug designation (ODD) by the FDA
X4 Pharmaceuticals X4P-001-RD WHIM syndrome, a primary immunodeficiency disease Granted Orphan Drug designation by the FDA
AcelRx Pharmaceuticals, Inc. DSUVIA™ Moderate-to-severe acute pain in medically supervised settings for adult patients FDA Anesthetic and Analgesic Drug Products Advisory Committee voted in favor of recommending approval
Sutro Biopharma, Inc. STRO-001 multiple myeloma Granted Orphan Drug designation by the FDA
Grifols ID CORE XT molecular diagnostic test Molecular red blood cell typing Granted approval by the FDA for use in the U.S.
UCB CIMZIA® (certolizumab pegol) Axial spondyloarthritis (axSpA) spectrum In Phase III trial, showed clinically relevant, statistically significant improvements in patients with active disease and signs of inflammation, as measured by major improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS-MI)