1. Pink Sheet
  2. >>Market Access

EMA’s PRIME Is Driving Innovation, But Too Early To Tell If Drugs Will Reach Patients Faster

 
• By Neena Brizmohun

With just three marketing applications filed, the European Medicines Agency says it is too soon to say whether PRIME, its priority medicines scheme, is meeting its objective. The agency is satisfied, though, that the scheme has started to drive innovation.

Woman doctor use tablet . Mixed media
The EMA says its PRIME scheme is driving innovation • Source: Shutterstock

The vast majority of applications for entry to the European Medicines Agency’s priority medicines scheme, PRIME, are still being denied two years after the launch of the popular initiative. Of those that have got on to the scheme, three have made it to the filing stage. While PRIME has not been running long enough to tell whether it is meeting its goal of getting medicines for unmet medical needs to patients faster, the EMA says the scheme is already showing benefits.

“In the two years since its launch… PRIME… has succeeded in driving innovation and improved the efficiency of the development...

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 Market Access

Crosstalk On Drug Pricing: Conflicts In Trump Team Rhetoric And Policy

 
• By Michael McCaughan

The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.

Price Inflation Rebates: Biden Policies Add Teeth To Trump’s Pharma Tariff Threat

 
• By Cathy Kelly

Companies with significant exposure to Medicare and Medicaid have fewer options for passing along higher costs to consumers because of price controls in the programs.

Not Over Yet: Eisai And Lilly To Appeal England’s ‘Flawed’ Refusal To Fund Leqembi And Kisunla

 
• By Neena Brizmohun

Eisai and Lilly explain why they disagree with today’s conclusion by the health technology assessment institute, NICE, that the benefits of their respective drugs for Alzheimer’s disease are too small to justify the additional cost to the National Health Service.

BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

More from Pink Sheet

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

New EU Filings

 
• By Neena Brizmohun

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.