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Featured Stories

EU Pharma Reform Talks Heat Up As Health Ministers Prepare To Challenge Proposals

In a sign of difficult negotiations to come on the European Commission’s pharma reform package, the presidency of the Council of the EU has drawn up its own set of proposals on regulatory data protection and market exclusivity that differ in several respects from those of the commission and the European Parliament.

Europe EU Legislative Reform Market Access

US FDA Creating Rare Disease ‘Hub’ To Serve As Center Of Excellence

While not brandishing the name advocates have pushed for many years, the rare disease hub will play much the same role as a center of excellence in increasing collaboration between experts in the FDA drug and biologics centers.

DIA Rare Diseases Regulation

Clinical Trial Diversity Action Plan Waivers Will Be ‘Very Rare,’ US FDA Official Says

With the much-anticipated guidance still pending, OCE’s Tamy Kim reminds industry of the requirements and timing around avoiding the soon-to-be requirements on study enrollments.

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 – April 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


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

Advisory Committee Consumer Reps Often Fail To Represent Consumer Interests, Groups Tell US FDA

Many positions are vacant or filled by individuals with ties to academia, industry or patient groups, representatives from public interest and consumer groups say during an FDA listening session on advisory committee reforms.

Advisory Committees FDA

US FDA’s Cell-Gene Therapy Office Head Wants Sponsors To Seek Out Meetings

Companies should talk to FDA staff in between formal meetings if they need clarity on agency advice that is several years old or development programs hit a snag, Office of Therapeutic Products Director Nicole Verdun says.

Gene Therapy Clinical Trials
Regional Comparisons

Project Orbis, 'Cluster' Calls Validate Global Regulators’ Drug Application Concerns

Regulators from the US, Canada, European Union, Switzerland and Japan talk about the benefits of global collaboration, and reasons why they might reach different decisions on the same drug, at the American Society of Clinical Oncology annual meeting.

Drug Review Regional Comparisons

Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?

EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.

Generic Drugs Regional Comparisons

For Generics, EU Reference Product Is Non-Negotiable – Even In Pilot On Parallel Advice

Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.

Generic Drugs Regional Comparisons

How The EU & UK’s Contrasting Approaches To AI Regulation Could Impact Pharma

While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms.

Artificial Intelligence Digital Health
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Recent Stories

340B Drug Diversion: Sanofi Suit Seeks Evidence In Pharmacy Contracts With Hospitals

Drug maker pursuing novel approach to establishing that contract pharmacies are improperly taking ‘title’ to 340B-discounted drugs, leading to diversion, which is prohibited by law.

Pricing Debate Legal Issues

‘We Tried It, It Does Not Work’ – The Problems With The EU’s SPC Manufacturing Waiver

While the European supplementary protection certificate manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.

Europe Legislation

Anti-Globalism Policy Cannot Stifle International Cooperation, US FDA’s Califf Says

The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.

DIA Supply Chain

Biosimilars: US FDA Heralds The End Of Switching Studies For Interchangeability

New guidance suggests that switching studies will no longer be expected as standard to support determinations of biosimilar interchangeability; instead, analytical and clinical data may suffice.

Biosimilars Guidance Documents

NICE Backs Vertex’s CF Drugs Kaftrio, Symkevi & Orkambi After Initial Rejection

Cystic fibrosis patients in England will be able to access Vertex’s three combination therapies after the company announced an extended reimbursement agreement with the National Health Service and a positive opinion from the country’s HTA body, NICE.

BioPharmaceutical Reimbursement

Korea’s Medical Vacuum Grows As Doctors Threaten Indefinite Walkout

Long-running protests by South Korean doctors against government reforms, including raising medical school admissions, continue to intensify with a one-day rally by community doctors and the threat of an indefinite walkout later this month. The pharma industry is also feeling the impact on clinical trials and sales. 

South Korea Policy

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 Vaccine Approvals Set Up CDC Votes On Merck’s Capvaxive, Moderna’s mResvia

Advisory Committee on Immunization Practices expected to vote 26-28 June on use of Merck’s 21-valent pneumococcal vaccine, Moderna’s mRNA vaccine for RSV, and an expanded age range for GlaxoSmithKline’s Arexvy RSV vaccine.

Approvals Vaccines

Advisory Committees: US FDA Should Explain Divergent Decisions But Keep The Vote

Agency should be more proactive in issuing communications after advisory committee meetings, stakeholders advised; public interest group and industry representatives said the voting process is important for transparency and accountability.

Advisory Committees Drug Review

EMA Explains How To Draw Up Shortage Prevention & Mitigation Plans

The shortage prevention plan (SPP) should be part of companies’ pharmaceutical quality system and will be open to inspection, while shortage mitigation plans (SMPs) should be proportionate to the level of risk for each medicine in line with ICH guideline Q9, the EMA says.

Europe Supply Chain

New EU Filings

Sepiapterin, PTC Therapeutics' treatment for hyperphenylalaninemia in adult and pediatric patients with phenylketonuria, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Drug Review Europe

Revised EU Trial Transparency Rules Go Live With Last Minute Changes To Address Confidentiality Concerns

The European Medicines Agency has met the deadline for launching a new version of the Clinical Trials Information System to allow earlier public access to information on authorized studies. However, new concerns raised by commercial sponsors means the publication of certain information fields in CTIS is temporarily suspended.

Europe Clinical Trials