FDA: New Approaches for Fatty Liver Clinical Trials

December 10, 2018

The FDA is encouraging fatty liver disease researchers to come up with new biomarkers for clinical trials to avoid invasive — and potentially dangerous — biopsies that drive away many would-be participants.

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


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 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.

New Training Standards Sought for PIs

December 3, 2018

Two influential clinical industry groups are focusing on new training efforts to prevent principal investigators from burning out and it appears that the FDA is willing to work with them on the effort.

FDA Wants to Modernize 510(k) Trials

December 3, 2018

The FDA says it wants to modernize device clinical trials by using more up-to-date technologies as comparators to make sure only the safest, most effective devices get to market.

New Pipeline Updates from Allergan, Bayer, Genentech and Pfizer

December 3, 2018

Company Drug/Device Medical Condition Status
GlycoMimetics Uproleselan (GMI-1271) Relapsed/refractory acute myeloid leukemia First patient enrolled in global Phase III trial
Sollis Therapeutics Clonidine micropellet Sciatica pain First patient enrolled in the RePRIEVE-CM trial
Stallergenes Greer Sublingual allergy immunotherapy tablet STAGR320 House dust mite (HDM)-induced allergic rhinitis Phase III trial met its primary endpoint with statistical significance in patients treated with STAGR320 compared to patients on placebo
Rocket Pharmaceuticals RP-L201 Severe Leukocyte Adhesion Deficiency-I FDA approved IND for Phase I trial
Pliant Therapeutics PLN-74809 Primary sclerosing cholangitis Granted Orphan Drug designation by FDA
Allergan Avycaz Complicated urinary tract infections and complicated intra-abdominal infections FDA accepted for review sNDA to expand label indication
NovImmune S.A. Gamifant® (emapalumab-lzsg) Primary hemophagocytic lymphohistiocytosis Granted approval by FDA
Pfizer Daurismo™ (glasdegib), to be used in combination with low-dose cytarabine (LDAC) Newly diagnosed acute myeloid leukemia in adults 75 years or older Granted approval by FDA
AbbVie and Genentech Venclexta® (venetoclax) Newly diagnosed acute myeloid leukemia in adults 75 years or older who cannot tolerate intensive chemotherapy Granted accelerated approval by FDA
Synthetic Biologics Synthetic Biologics Antibiotic-mediated Clostridium difficile infection Successfully completed End-of-Phase II meeting; Phase III go-ahead from FDA
Bayer and Loxo Oncology Vitrakvi (larotrectinib) Solid tumors with NTRK gene fusion Granted approval by FDA
HighTide Therapeutics HTD1801 Nonalcoholic steatohepatitis Fast Track designation granted by FDA


December 3, 2018: Job openings, upcoming industry conferences, webinars, training programs and academic programs

December 3, 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 Specialist – Hepatology
Dignity Health Research Institute
Phoenix, AZ

Clinical Trials Assistant
Marshfield Clinic Health System
Marshfield, WI

Clinical Trial Manager
Clinical Solutions Group
San Mateo, CA

Clinical Development Manager / Oncology Trials
Pioneer Data Systems, Inc.
San Francisco, CA

Director of Clinical Supply Project Leadership
East Hanover, NJ

Clinical Research Regulatory Specialist
Dignity Health Research Institute
Phoenix, AZ

Academic Programs

Boston College
Clinical Research Certificate Program
Chestnut Hill Campus, Newton, MA

Drexel University College of Medicine
Master’s/Certificate Programs in Clinical Research Organization and Management

University of North Carolina at Wilmington
MS Clinical Research and Product Development

Training Programs

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