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US FDA’s PANDA Policy Could Pose Legal Problems For Biosimilars, Attorney Says

Agency’s apparent intellectual exercise in treating pre-Hatch-Waxman ANDAs as NDAs could expose biosimilars to liability, Teva deputy general counsel notes at FDLI conference.

Biosimilars Legal Issues FDA

Status Quo At US FDA?

The news that the Biden Administration is considering asking Robert Califf to return as Commissioner of the US FDA is the latest twist in a most unusual transition process at the agency. But one message seems abundantly clear: the White House is perfectly happy with FDA as it is.

FDA Leadership Politics

ICH Emphasizes Need For Quality In Clinical Trials

The International Council for Harmonisation has delivered the first of a two-part project to modernize the international good clinical practice framework by finalizing changes to its primary efficacy guideline. 

Clinical Trials Regulation Guidance Documents

Spotlight On Coronavirus

Real-World Evidence Will Take Center Stage At US FDA Advisory Committee On COVID Boosters

If regulators agree with Pfizers conclusions – and briefing documents suggest thats a big if – about real-world studies showing Comirnatys effectiveness waning over time, thereby justifying the need for a booster dose, it could be part of a historical moment for FDA’s use of RWE.


Advisory Committees Coronavirus COVID-19

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Pink Sheet Podcast

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

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Performance Trackers

Earlier-Stage Approvals For Tecentriq, Keytruda, Verzenio Underscore Broader Oncology Trends

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals Cancer


Global Pharma Guidance Tracker – September 2021

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

Policy & Regulation Explore this Topic

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Latest From Regulation

EU CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Europe Drug Review

Vaccines’ Second Shift: CDC Nod Tends To Follow US FDA OK By Almost Nine Months

New vaccines’ journey to market has another stage after FDA approval: CDC and its Advisory Committee on Immunization Practices. In advance of the ACIP’s October meeting, a Pink Sheet infographic follows vaccines approved by the FDA over the last six years through ACIP to the commercially vital recommendation by CDC.

Vaccines Reimbursement

Makena Withdrawal Hearing: US FDA Drugs Center, Covis Tussle Over Panel Composition

Practicing obstetricians who are maternal fetal-medicine specialists should make up a ‘significant proportion’ of the advisory committee at the forthcoming hearing, Covis says; CDER calls for a more ‘balanced’ panel that includes expertise in biostatistics, neonatology and epidemiology.

Review Pathway Post Market Regulation & Studies

First-Of Kind BMS Drugs Among Myriad New Filings In EU

Marketing applications for 10 new drugs have been added to the latest list of products under review by the European Medicines Agency.

Europe Drug Review

EU Ups The Ante On Opposition To COVID-19 IP Waiver

Leaked documents show that the European Commission has prepared a new proposal on compulsory licensing of coronavirus products to be tabled at the World Trade Organization’s Ministerial Conference next month.

International Europe

Boehringer Ingelheim Wins Interchangeable Biosimilar To Humira, Setting Benchmark For Switching Studies

Cyltezo won’t be available until 2023 due to patent settlement with AbbVie. The second-ever interchangeable biosimilar approved by the US FDA also contains a first: published data from a switch trial.

Approvals Biosimilars

Latest From Policy

Three EU Countries Strike Landmark Joint Zolgensma Pricing Deal

BeNeLuxA, the cross-country medicines access initiative, says it is now the “gold standard” for voluntary collaboration in Europe after a ground-breaking deal was reached with Novartis.

Europe Belgium

Medicaid Spending On Accelerated Approvals ‘Outsized’ Relative To Use

A new study highlights a subset of high-cost drugs in Medicaid for which legal and policy tools may be available to manage spending growth.

Reimbursement Medicaid

MACPAC ‘Undeterred’ By Lukewarm Reception Of Accelerated Drug Approval Recommendation

Executive director Schwartz suggests Congress may turn its attention to the advisory commission’s proposal to revise Medicaid coverage for drugs approved under the accelerated approval pathway in the next year or two.

Medicaid Gene Therapy

Clinical / R&D Explore this Topic

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Latest From Research & Development

Pandemic Drives Rise In EMA Scientific Advice, But New EU Drug Filings Slow

The European Medicines Agency is expecting a lively pipeline of advanced therapy medicines over the next few years. It is also making final preparations for the introduction of the new EU clinical trials system from the end of January next year.

Europe Research & Development

Could Sponsors’ Supply Chain Policing Have Caught Alleged CRO Fraud?

The US FDA always encourages sponsors to ensure their suppliers and contractors are following the law, but agency inspectors may have been the only ones who could have discovered the data integrity problems that forced the downgrading of more than 100 generic drug applications.

Generic Drugs Research & Development

Pink Sheet Podcast: NIH Director Leaving, Federal COVID-19 Messaging Issues, FDA Assessment Costs

Pink Sheet editor and reporters discuss the impact of Francis Collins’ departure as NIH director, whether FDA and CDC COVID-19 messaging should be harmonized, and the narrowing gap between standard and priority assessment costs.

Leadership Coronavirus COVID-19

Commercial Explore this Topic

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Latest From Commercial

COVID-19 Leads To Less Industry Spend On Docs, But Not Necessarily Less Influence

Drug and medical device company payments to doctors and hospitals for non-research related activities dropped for the first time in 2020 since CMS’s Open Payments database began collecting the information. 

Advertising, Marketing & Sales Coronavirus COVID-19

Pink Sheet Podcast: Gene Therapy In Europe, Lilly’s Olympic TV Ads, 'Most Favored Nation' Rule

Pink Sheet reporters and editors discuss Bluebird Bio’s decision to pull its gene therapy business from Europe, Eli Lilly potentially pushing regulatory boundaries with its Olympic TV spots, and the CMS decision to scrap the Trump aministration’s most favored nation reimbursement rule.

Commercial Strategies Gene Therapy

A Prior Auth Truce? Novartis Willing to Embrace ICER-Like Price Determinations For Increased Access

Novartis gets some praise for being willing to embrace cost-effective drug prices, but health policy analysts are skeptical the industry would truly adopt the idea for its best-selling drugs, particularly if the appropriate guardrails were put in place to ensure broader budget impact was controlled.  Holes were also poked in the way Novartis determined the total cost of drug utilization management on the US health system. 

Pricing Debate Cost Effectiveness

Manufacturing Explore this Topic

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Latest From Manufacturing

EU Ups The Ante On Opposition To COVID-19 IP Waiver

Leaked documents show that the European Commission has prepared a new proposal on compulsory licensing of coronavirus products to be tabled at the World Trade Organization’s Ministerial Conference next month.

International Europe

EFPIA On Why More EU Drug Price Transparency Isn’t The Answer

As discussions continue over the European Commission’s plans to overhaul the EU pharmaceutical legislation, the R&D-based pharma industry body EFPIA says that any new pharma policy framework will need to be stable, fast, effective and globally competitive.

Europe Regulation

ICH Q9 Revision Delayed By Three Months Due To COVID; Focus Spans Risk Assessments, Shortages

Extension will add training materials with goal of reducing quality defects and recalls. Revision process will also address shortage indicators related to production failures in an attempt to head off drug shortages.

Manufacturing Quality
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