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Featured Stories

Accelerated Approval: Nippon Shinyaku’s Viltepso Fails DMD Confirmatory Trial, Raising Questions

The Duchenne muscular dystrophy treatment missed its primary endpoint of time to stand from supine in the RACER53 study, raising more questions about using dystrophin changes to support accelerated approval and the ability of functional endpoints to detect clinical change.

Post Market Regulation & Studies Rare Diseases Regulation

To Join Or Not To Join: The Challenges Of A Joint FDA-Sponsor Adcomm Briefing Document

3D Communications’ Nathan Gede says challenges related to submission timing, length and review format explain why sponsors may be reluctant to agree to a “point-counterpoint” style advisory committee briefing document, despite the Oncology Center of Excellence’s move in that direction.

Advisory Committees Drug Review Regulation

EU Crunch Time For Myriad Drugs Marks A Busy May Meeting For CHMP

The latest meeting of the European Medicines Agency’s human medicines committee, the CHMP, is taking place this week. Decisions are expected for 13 drug marketing applications, there will be a number of oral explanation meetings, and activity is expected relating to a drug at the center of a case involving the European Commission’s rejection of an EMA recommendation.

Drug Review Approvals Europe

Clinical Trial Reform

‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches

The current regulations were written when clinical trials involved far fewer entities, and a certain amount of ‘contortion’ is necessary when sponsors are trying to introduce decentralized, community-based and other modern elements, the FDA’s Kevin Bugin says in an interview with the Pink Sheet.

Clinical Trials Diversity & Inclusion

Read more Pink Sheet stories about clinical trials...

Latest News

Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

More Podcasts

Performance Trackers

PTC’s Upstaza Takes Gene Therapy Straight To Brain (And US FDA); Translarna To Return Mid-Year

In a year full of regulatory milestones for the firm, PTC Therapeutics hopes to set some approval precedents – and basically hopes its candidates have an easier time of it than they have had before.

US FDA Performance Tracker Gene Therapy 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


US FDA’s Novel Approvals Peak Near Year-End, Analysis Of Last Decade Suggests

The Center for Drug Evaluation and Research’s novel approvals concentrated in August, November, and December, while January and June were the slowest months, according to a Pink Sheet analysis of 2014-2023 data.

Approvals US FDA Performance Tracker

Weight Loss, Diabetes Treatments Focus Of FTC's Second Round Of Patent Listing Challenges

The Pink Sheet takes a deep dive into the Federal Trade Commission's second wave of challenges to patents it asserts are improperly listed in the FDA's Orange Book, including patents covering Novo Nordisk's self-injection pens for Saxenda (liraglutide) and Ozempic (semaglutide).

Intellectual Property Pricing Debate

As Biosecure Bill Moves Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs

Pink Sheet infographic details the timeframes and potential extensions under the House version of the bill, which just cleared committee.

Legislation Manufacturing

US FDA Transparency Win: Sponsors Know More Product-Specific Guidances Coming, Requests Fall

After creating a list of anticipated product-specific guidances to be published for generic sponsors and increasing PSG production, public requests for the agency to write a PSG declined.

Generic Drugs Guidance Documents
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

For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards

Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.

Drug Approval Standards Guidance Documents
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Recent Stories

EU Clinical Trials Discussion Platform Sets Off With Collaborative Tone

An eagerly-anticipated group has been set up in the EU to hold balanced discussions with multiple stakeholders on how to solve clinical trial-related issues.

Europe Clinical Trials

Pandemic Treaty Talks Flounder But WHO Still Holds Out Hope For Eventual Agreement

At this week’s World Health Assembly, a working group will be set up to discuss the next steps for talks on a global pandemic treaty and try to reach a final agreement on amendments to the International Health Regulations.

International Coronavirus COVID-19

How Pharma Can Use England’s Genomics Data To Improve Regulatory Filings & Trial Design

A real-world data research partnership involving Genomics England is helping pharma companies to continuously draw “more insights” from genomic information to improve their regulatory submissions and optimize trials.

Europe BioPharmaceutical

Platform Tech Designation: US FDA Emphasizes “Significant Efficiencies” Criteria In New Guidance

New draft guidance defines the necessary components of a platform technology designation request, including that sponsors demonstrate how it will save the FDA review time.

Platform Technologies Guidance Documents

‘Pivotal’ Regulation On EU Joint Clinical Assessments Extends Dossier Deadlines

Despite changes, industry remains concerned over the EU implementing regulation that sets out procedures for joint clinical assessments.

Europe Health Technology Assessment

Joint Clinical Assessments Of ATMPs Add To Ethical Concerns Over Need For Randomized Trials

Advances in cell and gene therapy, together with the forthcoming EU joint clinical assessments, have raised questions about the ethics of having to use randomized controlled trials to test new advanced therapies.

Europe Drug Approval Standards

Citeline Japan Awards 2024 - Enter Now!

The 15 July entry deadline for the Citeline Japan Awards 2024 in Tokyo is fast approaching, so here's a reminder to take a look at the categories and criteria and be sure you get those submissions in by this date. Sponsorship opportunities and tables are also available. 

Japan Commercial

International Health Regulation Changes Focus On Equitable Access And Production Capacity

The final version of amendments to the IHR is due to be discussed at this week’s World Health Assembly, alongside the way forward for the proposed global pandemic treaty.

International Coronavirus COVID-19

Global CRO Body Seeks US-Based Trial Sites With Novel Ideas For Improving Diversity

The Association of Clinical Research Organizations is offering to help clinical trials sites that want to make diversity and inclusion improvements, and generate learnings for the broader industry.

United States Clinical Trials

Lessons Learned From COVID-19 That Are Key To Future Global Pandemic Response

Panelists at a webinar discussed what went awry in the global response to the COVID-19 pandemic and the lessons to be learned in future in areas such as procurement, equitable access and regulatory processes.

Coronavirus COVID-19 Manufacturing

Novo’s Insulin Icodec Hypoglycemia Risk Outweighs Limited Benefit In Type 1 Diabetes–FDA Panel

The Endocrinologic and Metabolic Drugs Advisory Committee majority says new studies should validate the proposed risk mitigation measures before approval for T1D.

Advisory Committees Drug Review

US FDA Drug Center Tries New Approach To Old Consistency Problems

Drug developers should not expect the US FDA's new Quantitative Medicine Center of Excellence to dramatically impact the agency's long-standing problem of ensuring more consistent use of innovative regulatory approaches in application reviews.

Clinical Trials Review Pathway