1. Pink Sheet
  2. >>R&D

Neonatal Drug Development Could Benefit From Rare Disease Experience

 
• By Derrick Gingery

Early parent involvement in drug development and clinical trial design could improve recruitment and outcomes, stakeholders argue.

Neonatal ICU
Parents may be more interested in therapies that could help babies leave the NICU sooner, rather than an improvement in a clinical score. • Source: Shutterstock

The successful playbook for rare disease drug development, including involving patients and advocates in early stages, could help boost efforts to bring new neonatal products to market.

Neonatal drug development has fallen behind despite legislation to incentivize pediatric research. The Best Pharmaceuticals for Children Act (BPCA) and...

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 R&D

More from Pink Sheet

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.