• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Drug & Device Pipeline News

Drug & Device Pipeline News

January 16, 2023
Company Drug/Device Medical Condition Status
Trials Authorized
American CryoStem ATCell Long COVID/PASC IND for a phase 1 trial approved by the FDA
Immorna JCXH-105 shingles vaccine Shingles IND for a phase 1 trial approved by the FDA
Minerva Biotechnologies huMNC2-CAR22 (MUC1*-CAR-1XX) Metastatic breast cancer IND for a phase 1 trial approved by the FDA
Transgene TG6050 Advanced non-small cell lung cancer Phase 1 trial authorized by France’s regulatory authority
Orchard Therapeutics OTL-203 Hurler subtype of mucopolysaccharidosis type I IND for a phase 3 trial approved by the FDA
Trials Initiated
Cellf Bio BioSphincter implant Severe passive fecal incontinence Initiation of a phase 1 trial
Frontera Therapeutics FT-001 Leber congenital amaurosis 2 Initiation of a phase 1 trial
Theriva Biologics VCN-01 High-grade brain tumors scheduled for surgical resection Initiation of a phase 1 trial
Trevena TRV045 Epilepsy and other CNS disorders Initiation of a phase 1 trial
VYNE Therapeutics VYN201 Vitiligo Initiation of a phase 1a/b trial
Aprea Therapeutics ATRN-119 Advanced solid tumors with DDR mutations Initiation of a phase 1/2a trial
Avenge Bio AVB-001 Relapsed refractory ovarian cancer Initiation of a phase 1/2 trial
Hemab Therapeutics HMB-001 Glanzmann thrombasthenia Initiation of a phase 1/2 trial
Surface Oncology SRF114 Advanced solid tumors Initiation of a phase 1/2 trial
Bexion Pharmaceuticals BXQ-350 plus mFOLFOX7 and bevacizumab Newly diagnosed metastatic colorectal carcinoma Initiation of a phase 1b/2 trial
Alterity Therapeutics ATH434 Multiple system atrophy Initiation of a phase 2 trial
Compass Therapeutics CTX-009 Metastatic colorectal cancer Initiation of a phase 2 trial
Glycomine GLM101 Phosphomannomutase 2-congenital disorder of glycosylation Initiation of a phase 2 trial
Panbela Therapeutics CPP-1X-T (eflornithine tablets) Recent-onset type 1 diabetes Initiation of a phase 2 trial
Shanton Pharma SAP-001 Refractory and tophaceous gout Initiation of a phase 2b trial
Cyclo Therapeutics Trappsol Cyclo Early Alzheimer’s disease Initiation of a phase 2b trial
Biofrontera Bioscience Ameluz and BF-RhodoLED XL Actinic keratosis on the extremities, neck and trunk Initiation of a phase 3 trial
Maggie’s Pearl Epalrestat PMM2-CDG (phosphomannomutase-2-congenital disorder of glycosylation) Initiation of a phase 3 trial
Ocuphire Pharma Nyxol and Nyxol plus adjunctive low-dose pilocarpine therapy Presbyopia Initiation of a phase 3 trial
Zenas BioPharma Obexelimab Prevention of IgG4-related disease flare Initiation of a phase 3 trial
Innovent Biologics Mazdutide Type 2 diabetes Initiation of a phase 3 trial in China
Approvals
Biogen

Eisai
Leqembi (lecanemab-irmb) Alzheimer’s disease Accelerated approval granted by the FDA

 

To view more CenterWatch Weekly stories, click here.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing