Debarment Certification: A Must-Have in Any Clinical Trial Agreement

December 17, 2018

The debarment certification is one of the sections of central importance in a clinical trial agreement (CTA). This certification is a representation or warranty made by the institution, principal investigator, and, if applicable, affiliated hospitals or third-party facilities, that it is not debarred, disqualified or banned by the FDA from conducting clinical trials.


New Pipeline Updates from Genentech, Planmed Oy, and Gibson Oncology

December 17, 2018

Company Drug/Device Medical Condition Status
Bio-Thera Solutions BAT4306F CD-20-positive B-cell non-Hodgkins lymphoma Phase I trial initiated
Alligator Bioscience ATOR-1015 advanced solid tumor disease Phase I trial initiated enrolling up to 53 subjects at five clinics in Sweden and Denmark
Rodin Therapeutics RDN-929 snyaptopathies, a group of over 100 brain diseases characterized by synaptic loss and disfunction Phase I trial initiated
Protagonist Therapeutics, Inc. PN-10943 inflammatory bowel disease Phase I trial initiated
Aridis Pharmaceuticals AR-501 (gallium citrate) chronic bacterial lung infections in patients with Cystic Fibrosis Phase I/II trial initiated enrolling 96 (48 healthy and 48 with Cystic Fibrosis) subjects
Constellation Pharmaceuticals, Inc. CPI-1205 metsastic castration-resistant prostate cancer (mCRPC) Phase II trial initiated enrolling up to 35 subjects
KaNDy Therapeutics NT-814 troublesome post-menopausal symptoms, including hot flashes Phase II trial initiated enrolling up to 165 menopausal subjects aged 40 to 65 years
Levo Therapeutics, Inc. intranasal carbetocin (LV-101) Prader-Willi syndrome (PWS) Phase III trial initiated
Generex Biotechnology Corporation AE37 plus Keytruda (pembrolizumab) triple negative breast cancer IND clearance granted by the FDA
Virtus Pharmaceuticals, LLC generic Levorphanol Tartrate 2 mg tablets severe pain ANDA approval granted by the FDA
Asana Biosciences Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK) dual inhibitor ASN002 moderate-to-severe atopic dermatitis Fast Track Designation granted by the FDA
Gibson Oncology, LLC LMP-400 small molecule topoisomerase 1inhibitor Ewing sarcoma Rare Pediatric Disease Designation (RPDD) granted by the FDA
Sandoz, Inc. and Pear Therapeutics, Inc. reSET-O Opioid Use Disorder (OUD) Clearance granted by the FDA
Planmed Oy new features and intended uses of Planmed Verity orthopedic imaging solution reconstructive surgeries Approval granted by the FDA
Genentech Tecentriq and Avastin metastatic non-squamous non-small cell lung cancer (NSCLC) Approval granted by the FDA
Mayne Pharma Group Limited Tolsura (SUBA-itraconazole) systemic fungal infections Approval granted by the FDA



December 17: Job openings, upcoming industry conferences, webinars and training programs

December 17, 2018

Twice monthly, CWWeekly provides featured listings of clinical research job openings, upcoming industry conferences and educational programs from JobWatch, CenterWatch’s online recruitment website for both clinical research employers and professionals.

  For conferences, webinars, training programs and job postings, join the LinkedIn JobWatch group.
More Jobs

Clinical Research Coordinator II
US Oncology Research, Inc.
Rockville, MD

Clinical Research Coordinator
Meridien Research, Inc.
Maitland, FL

Clinical Trials Business Systems Analyst
UNC-Chapel Hill
Chapel Hill, NC

Clinical Trials Administrator
The University of Chicago
Chicago, IL

Translational Research Navigator
Vanderbilt University Medical Center
Nashville, TN

Nurse Clinician – Research
Dignity Health Research Institute
Phoenix, AZ

Upcoming Conference
Training Programs

JANUARY 1-31, 2019
Program Phlebotomy Training — Two Day Training
Various locations


New Pipeline Updates from Seattle Genetics, Novartis, Vybion and Notal Vision

December 10, 2018

Company Drug/Device Medical Condition Status
Innovent Biologics, Inc. IBI101, a recombinant fully human anti-OX40 monoclonal antibody (mAb) drug candidate Advanced solid tumors FDA approved Investigational New Drug (IND) application and plans to initiate Phase I clinical trial based on results from China Phase I trial
Sunny Pharmtech, Inc. and Vitruvius Therapeutics, Inc. Aminocaproic Acid Tablets 500 mg and 1000 mg tablets Fibrinolysis FDA approved Abbreviated New Drug Application (ANDA)
Vybion, Inc. INT41 Huntington’s disease FDA granted Orphan Drug designation
Ocular Therapeutix™, Inc. RP-L201 DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg Occular pain following eye surgery
Notal Vision, Ltd. Notal Vision Home-based Optical Coherence Tomography (OCT) System Home testing between doctor ntra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD) FDA granted Breakthrough Device designation
Mirati Therapeutics, Inc. MRTX849 Cancers driven by KRAS G12C mutations FDA has cleared the company’s Investigational New Drug (IND) application to initiate Phase I/II Trial
AbbVie Rovalpituzumab Tesirine (Rova-T) Second-line therapy for advanced small-cell lung cancer Halted Phase III trial due to shorter overall survival in the Rova-T arm
Genentech, Inc. Kadcyla® (ado-trastuzumab emtansine) HER2-positive early Breast cancer (EBC) Phase III KATHERINE trial met its primary end-point, significantly reducing risk of recurrence or death compared to Herceptin® (trastuzumab) as an adjuvant treatment
Global Blood Therapeutics Voxelotor Sickle cell disease in patients 12 and older Interim analysis of its Phase III HOPE study showed patients experienced “rapid, robust and sustained improvements in hemoglobin levels and measures of hemolysis with a favorable safety and tolerability profile”
Seattle Genetics Adcetris Previously untreated systemic anaplastic large cell lymphoma Granted approved by FDA
Novartis ligelizumab (QGE031) Chronic spontaneous urticartia (CSU) whose symptoms are inadequately controlled by H1-antihistamines Taking it into Phase III trials after a mid-stage trial showed out-performed Xolair
Janssen Pharmaceutical IMBRUVICA® (ibrutinib) plus rituximab Chronic lymphocytic leukemia (CLL); small lymphocytic lymphoma (SLL) Phase III trial results: significantly prolonged PFS compared to FCR in previously untreated patients aged 70 years or younger with CLL/SLL
Exelixis, Inc. and IPSEN Cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) previously untreated advanced HCC Previously untreated advanced hepatocellular carcinoma (HCC) initiation of COSMIC-312, a Phase III pivotal trial of this med versus sorafenib


Research Center Profiles

December 2018: Research Center Profiles

December 10, 2018

Research Center Spotlight is a monthly selection of clinical research centers who have Research Center Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their expertise and services in conducting and managing clinical studies. To learn more about becoming a Research Center Profile page subscriber, contact Sales at (617) 948-5100.