1. Scrip
  2. >>New Products

US Approval Delay For Green Cross But Long Term Strategy Intact

 
• By Jung Won Shin

Green Cross has hit a bump in its journey to commercialize an immunoglobulin product in the US, but analysts say the approval delay will not be a significant obstacle to its longer term North American strategy.

The US FDA has issued a complete response letter (CRL) on Green Cross Corp.'s biologics license application for I.V.-Globulin SN (IVIG-SN), a human immunoglobulin G for intravenous administration, which although set to delay an approval is not expected by analysts to exact a serious toll on the South Korean company's North American business plans.

The plasma-derived product is administered to protect the body against infection. Green Cross's BLA, filed in November 2015, was intended...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Nuvation Set For First Launch With Ibtrozi In Lung Cancer

 
• By Jessica Merrill

The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.

Pipeline Watch: ASCO Dominates Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

Ireland’s Got Biopharma Talent To Keep Leading The Pack

 
• By Kevin Grogan

The country’s life sciences investment head tells Scrip that it is business as usual for the sector despite the rumblings from across the Atlantic.

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By Kevin Grogan

Wales-based group launches with $140m series A.

BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 
• By Sarah Karlin-Smith and Mandy Jackson

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.