1. Pink Sheet
  2. >>Pathways & Standards

Boehringer Aims To Block GSK's Triple COPD Inhaler, Citing Combo Rule

 
• By Brenda Sandburg

GSK's triple COPD combo needs Phase III trial using comparators with same active ingredients and applying factorial design, BI contends in citizen petition to US FDA.

lung illustration

Boehringer Ingelheim Corp. contends that the study GlaxoSmithKline PLC conducted to support approval of its triple combination therapy for chronic obstructive pulmonary disease (COPD) is inadequate since it used a comparator with different active ingredients and a different delivery device than GSK's proposed product.

In a June 9 citizen petition, BI asks the US FDA not to approve any new drug application...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Approval Standards

More from Pathways & Standards

US FDA Staff Stability Should Be A Congressional Priority, Former Chief Of Staff Says

 
• By Derrick Gingery

Lawmakers should address FDA staff upheaval and help the agency “get back on track,” former agency Chief of Staff Elizabeth Jungman said, while CBER Director Vinay Prasad told staff he is asking ex-colleagues to return to the agency.

US FDA ‘Commissioner’s Voucher’ As Public Relations Tool

 
• By Michael McCaughan

NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to grab some attention.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.