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Project 2025 And The US FDA

A Trump-aligned think tank doesn’t have too much to say about the US FDA – which is probably a good thing for the agency. But it does reinforce the reality that abortion politics will continue to impact the agency – and that ties to industry may be a bipartisan area of concern.

FDA Leadership Politics

Slimmed-Down Obesity Drug Coverage In Medicare: First Step Or False Start?

A US House of Representatives bill to provide obesity drug coverage to a very select group of Medicare beneficiaries, passed only after Democrats debated whether the proposal is a “first step” towards broader coverage or a misstep counter to Medicare’s goals.

Medicare Legislation Policy

Pharma's 340B Legal Disputes Over Contract Pharmacies May Get A Boost With Chevron Ruling

But the overall impact of the Supreme Court decision may not seem as “immediate” in 340B compared to other federal programs.

Pricing Debate Legal Issues Litigation

Latest News

Pink Sheet Podcast

Performance Trackers

US FDA’s June Approvals Forecast: Nearly 30 Goal Dates Suggest Hot Start To Summer

June goal dates include RSV and pneumococcal vaccines, two COPD therapies, Rocket and Sarepta gene therapies, and lots of oncology.

US FDA Performance Tracker Drug Review Drug Approval Standards

Global Pharma Guidance Tracker – June 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation International


Multimedia

Approval Geography: Novel Agent Landscape Across US And EU

Pink Sheet infographic shows how a large majority of novel drugs make it past the US FDA before receiving approval in the European Union. Lag times ranged from almost five years to less than two weeks.

Regional Comparisons Approvals

US FDA’s Dry July? Few Goal Dates Portend Quiet Month For Approvals

Sun’s deuruxolitinib and Novo Nordisk’s insulin icodec stand out as new molecular entities among the small cluster of US FDA user fee goal dates in July.

US FDA Performance Tracker Review Pathway

China Sets Clinical Trial Record But Starting Studies Can Be Challenging

Antibody-drug conjugates, GLP-1 receptor agonists and cell/gene therapies propelled a big increase in clinical trial registrations in China last year, but why do sponsors sometimes remain reluctant to actually start studies?

China Clinical Trials

US FDA User Fee Conundrum: Collections Increase After 25% PDUFA Rate Hike

With likely more fee-paying applications arriving at the agency, sponsors may be wondering whether user fees should have been increased as much as they were at the start of FY 2024.

User Fees Drug Review
Regional Comparisons

US FDA Offers Faster Route To Market Than EMA: Details On All 108 Approvals

Comprehensive table comparing all the novel agents approved by either the US FDA or the European Commission over 2023 through April 2024.

Regional Comparisons Approvals

Approval Geography: Novel Agent Landscape Across US And EU

Pink Sheet infographic shows how a large majority of novel drugs make it past the US FDA before receiving approval in the European Union. Lag times ranged from almost five years to less than two weeks.

Regional Comparisons Approvals

New Oncologics Overwhelmingly Approved In US Before EU

Ninety-five percent of novel cancer treatments approved in both the US and Europe received the FDA’s OK first, but Europe usually followed within a year, a Pink Sheet analysis shows.

Regional Comparisons Approvals

Getting To Global Is A Hurdle For Cell And Gene Therapies

Only three of the 10 new therapies approved by the US FDA also have been approved in the European Union, while both of the EU gene therapy approvals followed FDA clearance, a Pink Sheet analysis shows.

Regional Comparisons Gene Therapy
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Recent Stories

Japan Makes Renewed Policy Efforts To Fill 'Drug Gap'

Japan has announced several new measures to tackle the lack of rare disease and other therapeutics in the domestic market, with the country's main industry association also issuing the first common national informed consent form in a bid to lighten the “huge workload” on trial site staff.

Japan Drug Review

EMA Tightens Clock-Stop Rules To Address Impact On Drug Approval Timelines

The European Medicines Agency says that in 2022, the average time taken up by clock-stops exceeded the average time of drug assessment.

Europe Drug Approval Standards

Uptake Of Innovation Is UK’s ‘Biggest Hurdle’ In Life Sciences Competitiveness

The latest report on the competitiveness of the UK’s life sciences sector shows that the nation “continues to underperform” on its potential in terms of the adoption of new treatments and innovation, according to industry body the ABPI.

Europe United Kingdom

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Ixchiq, Valneva's chikungunya virus vaccine

Europe Approvals

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 

Advisory Committees Drug Review

Life After Chevron: User Fee Cycle May Help US FDA In Era Of Uncertainty

US federal agencies are entering a new era of uncertainty and increased litigation over their regulatory interpretations, but the FDA may benefit from the unique circumstances that have evolved through user fee legislation.

Legal Issues User Fees

Accelerated Approval: ALS Drug Could Test New Congressional Directive On Survival

Clene leadership spoke with the Pink Sheet about its push for accelerated approval for its ALS nanoparticle treatment. A new nudge from Congress asking the US FDA to consider survival data in accelerated approval could help.

Drug Approval Standards FDA

How The IRA Factored Into Akebia’s Price For Vafseo

Akebia says its price for Vafseo at about $15,500 per year, meant to reflect its potential value in dialysis as well as eventually in non-dialysis patients.

Medicare Renal

Rise In Threats Prompts Call To Shield Expert Identities Under EU Access To Document Policy

The European pharmaceutical industry federation wants regulators who handle requests for access to documents to safeguard the identities of all experts and designated personnel, not just those engaged in animal studies. 

Europe Compliance

In Vitro Triumph: European Pharmacopoeia Abolishes Rabbit Pyrogen Test

The use of the RPT is to no longer be required in any text of the European Pharmacopoeia and medicine developers will have to select a suitable in vitro test to control the pyrogenicity of their product.

Europe Animal Testing

Medicines Patent Pool Calls For Equitable Access To Infectious Disease mAbs

In a joint proposal with its partners, the Medicines Patent Pool explores challenges in monoclonal antibody equity in low- and middle-income countries and provides actionable solutions to increase development and manufacturing.

Biosimilars Intellectual Property

US FDA Offers Faster Route To Market Than EMA: Details On All 108 Approvals

Comprehensive table comparing all the novel agents approved by either the US FDA or the European Commission over 2023 through April 2024.

Regional Comparisons Approvals
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