Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

G1 Therapeutics Inc.

http://www.g1therapeutics.com/

Latest From G1 Therapeutics Inc.

Keeping Track: Jardiance Approved Across Heart Failure Spectrum, But US FDA Turns Down Bardoxolone, Terlipressin

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Approvals Drug Approval Standards

First-In-Class Drugs Made Up More Than Half Of US FDA’s Novel Approvals Last Year

CDER hit a high mark with 27 first-in-class approvals in the 50 novel agents cleared in 2021.

Approvals Drug Approval Standards

Xbrane Joins Forces With Contract Manufacturer For Cimzia Biosimilar

Sweden’s Xbrane Biopharma has secured a manufacturing partner in its native Scandinavia, Denmark’s AGC Biologics, to help complete key steps for its proposed Xcimzane (certolizumab pegol) biosimilar to Cimzia ahead of Phase I and Phase III clinical trials.

Biosimilars Deals

Provention Maps Possible Regulatory Path For Troubled Teplizumab

Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.

Companies Regulation
See All

Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
UsernamePublicRestriction

Register