New Pipeline from CeraPedics, Armagen, Endomag and Sensus Healthcare

August 6, 2018

Company Drug/Device Medical Condition Status
Clover Biopharmaceuticals, Inc. SCB-808 rheumatoid arthritis (RA) and other autoimmune diseases Phase I trial initiated
Arcus Biosciences, Inc. AB154 anti-TIGIT antibody Phase I trial initiated
CeraPedics P-15L Peptide Enhanced Bone Graft transforaminal lumbar interbody fusion (TLIF) surgery Phase I trial initiated enrolling 364 subjects
BioLineRx Ltd. AGI-134 patient-specific tumor neoantigens Phase I/IIa trial initiated
Avelas BioSciences, Inc. AVB-620 primary, non-recurrent breast cancer undergoing surgery Period II, Phase II trial initiated enrolling 31 subjects
Biohaven Pharmaceutical Holding Company, Ltd. trigriluzole (BHV-4157) mild-to-moderate Alzheimer’s disease (AD) Phase II/III trial initiated enrolling 292 subjects
Kala Pharmaceuticals, Inc. KPI-121 0.25% dry eye disease Phase III trial initiated enrolling 900 subjects
GE Healthcare and Lantheus Holdings, Inc. Flurpiridax coronary artery disease Phase III trial initiated enrolling 650 subjects
Progenics Pharmaceuticals Azedra adult and pediatric subjects 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy NDA approval granted by the FDA
United Therapeutics Corporation Remodulin pulmonary arterial hypertension (PAH) NDA approval granted by the FDA
Sensus Healthcare, Inc. SRT-100+ non-melanoma skin cancer and keloids 510(k) clearance granted by the FDA
Modulated Imaging Clarifi Imaging System peripheral vascular diseases, diabetic foot ulcers, burns, skin flaps and chronic wounds 510(k) clearance granted by the FDA
Daiichi Sankyo Company, Ltd. quizartinib relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) Breakthrough Therapy Designation granted by the FDA
Armagen Inc. GT-184 Mucopolysaccharidosis type IIIA (also known as Sanfilippo Syndrome A or MPS IIIA) Orphan Drug Designation granted by the FDA
Endomag Magtrace breast cancer PMA granted by the FDA
Hologic, Inc. Panther Fusion GBS assay Group B Streptococcus (GBS) Clearance granted by the FDA
Shionogi & Co., Ltd. Mulpleta (lusutrombopag) thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure Approval granted by the FDA
Roche cobas cervical cancer Approval granted by the FDA
Indivior PLC PERSERIS schizophrenia Approval granted by the FDA