Archives

Pipeline

New Pipeline from Adaptiiv, Zavation, Astellas, and Ironwood

July 23, 2018

Company Drug/Device Medical Condition Status
Blade Therapeutics BLD-2660 debilitating fibrotic diseases Phase I trial initiated
SOM Biotech SOM3355 chorea movements associated with Huntington’s disease Phase II trial initiated enrolling 30 subjects
Concentric Analgesics, Inc. CA-008 post-surgical pain Phase II trial initiated
Ironwood Pharmaceuticals, Inc. linaclotide irritable bowel syndrome with constipation (IBS-C) Phase IIIb trial initiated enrolling 600 adult IBS-C subjects in the U.S.
RDD Pharma RDD-0315 fecal incontinence in subjects with spinal cord injury IND clearance granted by the FDA
MaxCyte MCY-M11 (chimeric antigen receptor (CAR) therapeutic candidate) solid tumors IND clearance granted by the FDA
Stryker Corporation Surpass Streamline Flow Diverter unruptured large and giant wide neck intracranial aneurysms PMA granted by the FDA
Astellas Pharma Inc. and Pfizer Inc. XTANDI (enzalutamide) castration-resistant prostate cancer, including men with non-metastatic CRPC sNDA approval granted by the FDA
Adaptiiv 3D Bolus Software cancer 510(k) clearance granted by the FDA
Zavation Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage) cervical spine (C2-C7) and thoracolumbar spine (T1-L5) for partial or total replacement of a diseased, collapsed, damaged or unstable vertebral body 510(k) clearance granted by the FDA
Quidel Corporation Solana Bordetella Complete Molecular Diagnostic Assay detection of Pertussis (whooping cough) Parapertussis Infections 510(k) clearance granted by the FDA
Genentech TECENTRIQ (atezolizumab) in combination with Avastin (bevacizumab) chronic lymphocytic leukemia Breakthrough Therapy Designation granted by the FDA
Gamida Cell NiCord hematopoietic stem cell transplantation (HSCT) Orphan Drug Designation granted by the FDA
Inozyme Pharma INZ-701 ENPP1 Deficiency (GACI in infants and ARHR2 post-infancy) Orphan Drug Designation granted by the FDA
Vallum Corporation polyetheretherketone (PEEK) spinal interbody fusion device spinal fusion Clearance granted by the FDA
SIGA Technologies Inc. and U.S. Department of Health and Human Services’ BARDA TPOXX (tecovirimat) smallpox Approval granted by the FDA
Janssen Pharmaceutical Companies of Johnson & Johnson SYMTUZA darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults Approval granted by the FDA