FDA on Real-World Evidence: Let’s Keep Talking
December 10, 2018
The FDA has issued its long-awaited plan on real-world evidence, a document that many in the industry read as the beginning of a conversation.
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News
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.
GSK Back in Cancer Business with $5.1 Billion Tesaro Merger
December 10, 2018
GlaxoSmithKline is getting back into the cancer business in a big way, with a proposed $5.1 billion takeover of Tesaro, maker of cancer gene therapy Zejula (niraparib).
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 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.
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.
CRO Merger Widens Pediatric Trials Portfolio
December 3, 2018
Syneteract, a global North Carolina-based CRO, has acquired niche CRO KinderPharm in a deal Synteract says will help it expand its pediatric trials footprint.
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.
Jobs via Kelly Services
Clinical Trials Assistant II
East Hanover, NJ
Clinical Laboratory Technician – DNA/RNA Lab – NIH
Baltimore, MD
Senior Statistical Analyst
South San Francisco, CA
HR Specialist
Milwaukee, WI
Pharmaceutical Chemist-Entry Level
Round Rock, TX
Associate Application Scientist
Waltham, MA
Upstream Process Development Scientist
Houston, TX
Design Quality Engineer
Raynham, MA
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
Novartis
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
Online
University of North Carolina at Wilmington
MS Clinical Research and Product Development
Online
Upcoming Conference
DECEMBER 10-12, 2018
Design Of Medical Devices Conference, China 2018
Beijing, China
DECEMBER 11-12, 2018
ICH E6 GCP Interactive Workshop
Raleigh, NC
DECEMBER 12-13, 2018
Building a World-Class Advertising And Promotion Review Program
Raleigh, NC
APRIL 15-18, 2019
18th Annual Design Of Medical Devices Conference Graduate Minneapolis and McNamara Alumni Center
Minneapolis, MN
Training Programs
JANUARY 1-31, 2019
Phlebotomy Training — Two Day Training
Various locations
Webinars
DECEMBER 12, 2018
Transforming Quality Management With Modern Technology
December 18, 2018
Medical Device Voluntary
Malfunction Disclosure Regulation Are You Up to Date on the Latest Developments?
December 18, 2018
Medical Device Cybersecurity Risks & Best Practices Navigating the Nuanced Cyber Regulatory Waters
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