New Pipeline Updates from OSSIO, TransEnterix and Abbott

January 21, 2019

Company Drug/Device Medical Condition Status
ADC Therapeutics ADCT-601 advanced or metastatic solid tumors Phase I trial initiated enrolling 75 subjects
Mirati Therapeutics, Inc. MRTX849 advanced solid tumors that harbor KRAS G12C mutations Phase I/II trial initiated
Promentis Pharmaceuticals, Inc. SXC-2023 moderate to severe trichotillomania in adults Phase II trial initiated enrolling 100 subjects in the U.S.
Innovent Biologics, Inc. Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) in combination with capecitabine and oxaliplatin advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma (GC or GEJ) Phase III trial initiated enrolling 650 subjects in China
TransEnterix Senhance Ultrasonic System minimally invasive surgery 510(k) clearance granted by the FDA
OSSIO OSSIOfiber Bone Pin stability and secure bone fixation during the orthopedic healing process 510(k) clearance granted by the FDA
Mundipharma International Flutiform pMDI asthma treatment in children five years of age or older Approval granted by the EMA
Bristol-Myers Squibb Company Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC) Approval granted by the EMA
iSchemaView RAPID neuroimaging platform stroke patients who are likely to benefit from endovascular thrombectomy (clot removal) 510(k) clearance granted by the FDA
Novartis crizanlizumab (SEG101) prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD) Breakthrough Therapy Designation granted by the FDA
Exelixis, Inc. CABOMETYX (cabozantinib) tablets hepatocellular carcinoma (HCC) NDA approval granted by the FDA
AIVITA Biomedical anti-PD1 monoclonal antibodies in combination with AV-MEL-1 metastatic melanoma IND approval granted by the FDA
NeoImmuneTech, Inc. and Genexine Hyleukin-7 (IL-7-hyFc) and atezolizumab (Tecentriq) high-risk skin cancers IND approval granted by the FDA
Zydus Cadila Amlodipine in combination with Atorvastatin high blood pressure and lowering cholesterol ANDA approval granted by the FDA
Amneal Pharmaceuticals, Inc. generic version of Exelon Patch (Rivastigmine Transdermal System), 4.6 mg/24 hours, 9.5 mg/24 hours and 13.3 mg/24 hours mild to moderate dementia caused by Alzheimer’s or Parkinson’s disease ANDA approval granted by the FDA
Abbott Amplatzer Piccolo Occluder patent ductus arteriosus (PDA) in premature babies and newborns Approval granted by the FDA
Sanofi Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) repeat vaccination to help protect against tetanus, diphtheria and pertussis Approval granted by the FDA