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Home » Pipeline

Pipeline

November 24, 2019
Company Drug/Device Medical Condition Status
CStone Pharmaceuticals ivosidenib relapsed or refractory acute myeloid leukemia Phase 1 trial initiated enrolling subjects with IDH1 mutant relapsed or refractory acute myeloid leukemia (R/R AML)
Seelos Therapeutics, Inc. SLS-002 Central Nervous System (CNS) disorders and rare diseases Phase 1 trial initiated enrolling 48 healthy volunteers
Spring Bank Pharmaceuticals, Inc. SB 11285 advanced solid tumors Phase 1 trial initiated at multiple sites in the U.S.
Celldex Therapeutics, Inc. CDX-0159 chronic idiopathic urticaria (CIU) Phase 1a trial initiated enrolling 32 healthy subjects
Medivir AB MIV-818 liver cancer Phase 1a trial initiated enrolling nine subjects with advanced liver cancer
Enlivex Therapeutics Ltd. Allocetra severe sepsis Phase 1b trial initiated enrolling 10 subjects
Phoenix Molecular Designs PMD-026 triple negative breast cancer Phase 1/1b trial initiated enrolling subjects with metastatic breast cancer and triple negative breast cancer at sites in the U.S.
Sensei Biotherapeutics SNS-301 in combination with pembrolizumab ASPH positive head and neck cancer Phase 1/2 trial initiated enrolling 30 subjects
Axial Biotherapeutics AB-2004 Autism Spectrum Disorder (ASD) Phase 1b/2a trial initiated enrolling 25 male adolescent subjects
Inotrem S.A. nangibotide septic shock Phase 2b trial initiated enrolling 450 subjects with septic shock at 48 sites across five countries in Europe and the U.S.
Viking Therapeutics VK2809 non-alcoholic steatohepatitis Phase 2b trial initiated enrolling 340 subjects with biopsy-confirmed NASH and fibrosis ranging from stages F1 to F3 at multiple sites
BiondVax Pharmaceuticals Ltd. M-001 universal flu vaccine Phase 3 trial initiated enrolling 12,463 subjects ages 50 years and older, including 6,291 ages 65 and older at 83 sites in eastern European countries
Achillion Pharmaceuticals, Inc. danicopan (ACH-4471) paroxysmal nocturnal hemoglobinuria (PNH) in patients who are not adequately responding to a C5 inhibitor PRIME Designation granted by the EMA
Carestream Focus 35C Detector with Image Suite Software medical imaging 510(k) Clearance Granted by the FDA
Merit Medical Systems, Inc. WRAPSODY stenosis within the central veins of the outflow circuit of an arteriovenous fistula (AVF) up to the superior vena cava Breakthrough Device Designation granted by the FDA
Siemens Healthineers SOMATOM X.cite single-source computed tomography (CT) scanner Clearance granted by the FDA
AstraZeneca Calquence chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Supplemental Approval granted by the FDA
BeiGene BRUKINSA (zanubrutinib) mantle cell lymphoma (MCL) Accelerated Approval granted by the FDA
CooperVision MiSight 1day contact lens myopia in children eight to 10 years of age Approval granted by the FDA
Pfizer Abrilada (adalimumab-afzb) rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis Approval granted by the FDA
CeraPedics, Inc. i-FACTOR Peptide Enhanced Bone Graft degenerative cervical disc disease PMA Approval granted by the FDA
Novartis Adakveo (crizanlizumab) sickle cell disease Approval granted by the FDA
Q Biomed Inc. Strontium-89 skeletal metastases caused by cancer Approval granted by the FDA
Alnylam Pharamceuticals, Inc. GIVLAARI (givosiran) injection acute hepatic porphyria (AHP) Approval granted by the FDA

 

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