1. Scrip

Basilea's Ceftobiprole Dubbed Qualified Infectious Disease Product

 
• By Donna Young

Basilea Pharmaceutica's ceftobiprole was designated by the FDA as a qualified infectious disease product – a status under which the drug is eligible for an additional five years of market exclusivity if approved for the indications.

Basilea Pharmaceutica's ceftobiprole was designated by the FDA as a qualified infectious disease product – a status under which the drug is eligible for an additional five years of market exclusivity if approved for the indications.

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 Archive

More from Scrip

In Brief: Genmab To Seek FDA Nod For Epkinly In Lymphoma

 
• By Sushmita Panda

Genmab will submit an sBLA for Epkinly in R/R follicular lymphoma in H1 2025, backed by positive Phase III data.

Pharma Predicts Modest Impact From Tariffs, But It Depends On What Comes Next

 
• By Jessica Merrill

Drugmakers aren’t expecting a big financial hit from tariffs for now, but a report commissioned by PhRMA suggests the cost of pharma-sector tariffs could be steep.

OPPI’s Matai On Section 3(d) Of India’s Patent Regulations: Now’s The Time To Open Up

 
• By Anju Ghangurde

Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.