1. Pink Sheet
  2. >>Legislation

Mylan/Biocon’s Insulin Glargine Would Get A Respite Under US Budget Legislation

 
• By Cathy Kelly

Bill addresses ‘dead zone’ for pending applications for protein products transitioning to biologic status; generic and brand industries each win in different legislative provisions: inclusion of the CREATES Act, and a revised definition for ‘biologics’ that includes chemically synthesized polypeptides.

Syringe

The broad federal budget bill approved by US House and Senate negotiators on 16 December offers relief to sponsors of pending marketing applications for insulin, human growth hormone and other protein agents that are scheduled to transition to biologic status beginning early next year.

The legislation, which must be approved by Congress and the White House by 20 December, would require the Food 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 Legislation

Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 
• By Neena Brizmohun

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

Plans For EU Biotech Act Shift Up A Gear

 
• By Eliza Slawther

Companies have until early November to respond to a public consultation from the European Commission on its planned Biotech Act, which it hopes will help unleash the potential of small and midsize enterprises in the bloc.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By Vibha Sharma

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

Advocates Want New Bipartisan PBM Reform Package To Stand Alone

 
• By Leslie Small

A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.

More from Pink Sheet

Ultragenyx Says CRL Discussions ‘Productive’ Despite US FDA Leadership Upheaval

 
• By Jessica Merrill

Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

ICH Proposes Global Framework For Managing Leachables In Pharma Products

 
• By Vibha Sharma

The International Council for Harmonisation has developed a holistic approach for the assessment and control of leachable impurities, supporting drug product development, registration and ongoing quality management throughout the product lifecycle.