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US FDA’s New Voucher Fee Reveals Standard, Priority Review Cost Spike

The number of standard and priority reviews also decreased significantly in FY 2023 compared to the previous year, which caused the fee for redeeming a voucher to rise.

User Fees Review Pathway Regulation

Prior Authorization Reform: 2025 Could Be A Year Of Changes

Prior authorization reforms could emerge as an important under-the-radar area of drug policy next year. An upcoming Medicare proposed rule, the extraordinary uptake of weight loss therapies, and the launch of the overhauled Part D benefit design will all drive attention to the issue.

Reimbursement Medicare Regulation

340B Rebate Dispute: HRSA Threat To Bar J&J From Medicare Part B, Medicaid ‘Unprecedented’

HRSA threatens nuclear option and Johnson & Johnson suspends its 340B rebate model. But the company also ‘reserves all of its legal rights with respect to this matter.’

Pricing Debate Regulatory Medicare

The View From TOPRA

EMA’s AI Principles Intended To Be ‘Flexible & Long Lasting’

There is “a lot of flexibility” in the European Medicines Agency’s reflection paper on the use of artificial intelligence during drug development, which is principles-driven rather than setting rigid recommendations, says the agency’s Florian Lasch.

BioPharmaceutical Artificial Intelligence

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 – August 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

Growth Spurt: Pediatric Labeling Is On The Rise, Taxing US FDA Safety Monitoring

The US FDA Pediatric Advisory Committee uses web-posted reviews of “low safety risk” products to keep up with postmarketing monitoring requirements amid rising interest in pediatric development.

Pediatrics Drug Safety

US FDA's Slim October User Fee Calendar Brings Some Controversy

Advisory committee concerns cast clouds over Iterum’s oral antibiotic, Intercept’s Ocaliva, and perioperative immuno-oncology regimens, while CSL and Pfizer aim to take their hematology franchises in new directions.

US FDA Performance Tracker Drug Review

BIOSECURE Act: Potential Supply Chain Hits And Pharma’s Path Ahead

With BIOSECURE's legislative progress on pause until after the election, a Pink Sheet infographic looks back on the Capitol Hill progress to date and looks ahead to the potential impact if it is enacted, using Evaluate Pharma data to highlight the likely holes in pharma’s supply chain.

Manufacturing Legislation

Inflation Continues To Rear Head At US FDA User Fees

Inflation accounted for a larger portion of user fee revenue target increases for fiscal year 2025, compared to previous years, according to a Pink Sheet analysis.

User Fees Review Pathway
Regional Comparisons

How The UK, EU, Canada, Australia And Japan Are Tackling Diversity In Clinical Trials

As efforts to improve diversity in clinical trials gain momentum globally, the Pink Sheet asked regulators in the UK, the EU, Canada, Australia and Japan about their efforts to support representative enrolment. 

Regional Comparisons Diversity & Inclusion

EU Revokes Intercept/Advanz’s Ocaliva Approval As Moment Of Reckoning Nears in US

The EU marketing authorization for the primary biliary cholangitis treatment has now been revoked. Meanwhile the drug's approval is in jeopardy in the US, where an advisory committee will opine on whether the accelerated approval drug has confirmed clinical benefit.

Regional Comparisons Post Market Regulation & Studies

England Lags Behind Eight European Countries On Innovative Drug Availability

In this third article of a series on new drug reimbursement recommendations by the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are reimbursed in England than in eight other European nations.

BioPharmaceutical Europe

Decoding Regulatory Agency Decisions: The Case of Amylyx’s Relyvrio/Albrioza In The US And EU

Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores how the two agencies applied the available regulatory flexibilities and the impact of other factors, such as regulatory precedence and patient influence, on decision-making.

Europe United States
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Recent Stories

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

England Plans New Model For Use Of Lilly’s Mounjaro In Weight Loss

NHS England says it is proposing a “realistic but challenging uptake trajectory” that will make “this clinically and cost-effective drug” available to as many patients as possible without overwhelming health care providers.

Europe United Kingdom

EMA’s AI Principles Intended To Be ‘Flexible & Long Lasting’

There is “a lot of flexibility” in the European Medicines Agency’s reflection paper on the use of artificial intelligence during drug development, which is principles-driven rather than setting rigid recommendations, says the agency’s Florian Lasch.

BioPharmaceutical Artificial Intelligence

US FDA Eager To INTERACT With Start-Ups, Not Check Boxes

A US FDA webinar for start-up sponsors showcased staff who sound enthusiastic about helping drug developers advance their projects, while also emphasizing the importance of early and continual engagement with the agency.

Research & Development Review Pathway

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

Advisory Committees Drug Review

US Medicare Cost For Part D Redesign Could Far Exceed Earlier Projections, CBO Says

Instead of $5bn in 2025, the redesign could cost the federal government two to four times that amount, the Congressional Budget Office told Republican lawmakers. And the Part D premium stabilization demonstration will cost an additional $7bn, the office projected.

Reimbursement Policy

EU HTA Regulation: ‘We Don’t Want An Empty Dossier,’ Warns Coordination Group

Manufacturers that do not answer all questions they are asked during joint clinical assessments under the upcoming EU HTA Regulation could have their applications deemed incomplete, says a co-chair of the JCA subgroup.

TOPRA BioPharmaceutical

Gene Therapy Hemgenix Gains Ground In Europe With Spanish Reimbursement Deal

Hemgenix has now secured reimbursement in several European markets, with more talks ongoing. While the path to reimbursement has not always been easy, innovative access deals have helped to smooth the way.

Europe Reimbursement

UK Expedites Cost Negotiations For Companies Conducting ATMP & Early Phase Trials

Companies dealing with commercial costings or contracts with the National Health Service for early phase clinical trials or trials of advanced therapy medicinal products should soon be able to conclude their negotiations more quickly.

United Kingdom Clinical Trials

Patient/CMS Roundtables For Medicare-Negotiated Drugs Will Be Interactive, But Not Public Next Time

The final Medicare price negotiation guidance for the next cycle includes improvements from last year’s patient listening sessions.

Pricing Debate Medicare

US FDA And AI: Who Is In Charge?

The FDA is developing several structures and a broad group of experts across disciplines to help craft artificial intelligence policy. But the proliferation of AI-related initiatives raises the question of who, ultimately, will make decisions about when novel applications of AI are acceptable.

Artificial Intelligence Leadership

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

The US FDA Commissioner pushed for rebalancing the US’s pharmaceutical supply chains while also stressing that US-China commerce has a role that would be risky to compromise. 

Supply Chain Manufacturing
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