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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 Drug Approval Standards

FDA Advisors Leave Door Open To Mix and Match COVID-19 Vaccine Boosters

Discussion also reopened the debate on allowing universal boosting with mRNA vaccines, with advisors giving FDA more leeway to allow some younger Americans to get an additional mRNA shot regardless of their occupation or underlying health conditions.

Coronavirus COVID-19 Vaccines Advisory Committees

Confronting The Challenges Of Marketing Cell And Gene Therapies

The “chronic disease paradigm” presents a real challenge for companies marketing advanced therapies.

Europe North America United States

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

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

Janssen Gets US FDA Panel Nod For Additional COVID Vaccine Shot – But Is It A ‘Booster’?

Advisory committee members say clinical data proves the second shot should be considered part of the primary series, while Janssen wants it called a single-shot vaccine with a booster.

Vaccines Coronavirus COVID-19

Gilead’s First-In-Class Drug For Aggressive Breast Cancer On Track For EU Approval

EU reviewers have recommended five new medicines and a pneumococcal vaccine for EU-wide approval. New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.

Approvals Drug Review

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

Recent And Upcoming FDA Advisory Committee Meetings

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

Advisory Committees Drug Review

Latest From Policy

Pfizer’s ‘Industry First’ Warranty Program For Xalkori Available To Medicare Part D Patients

Pilot program offers Part D beneficiaries an alternative to manufacturer assistance in the form of copay coupons, which are prohibited in government-sponsored health plans. New program also available to commercial insurance and cash-paying patients.

Medicare Reimbursement

Under The Shadow Of Drug Price Reform, US Tax Policies Still Challenge Pharma

Congress is considering legislation that would reverse some of the Trump administration's friendly corporate tax policies, presenting another challenge to the biopharmaceutical industry.

Politics Sales & Earnings

European Countries Call For Health Technology Assessments Of COVID-19 Products

Value assessments of COVID-19 monoclonal antibodies should inform pricing decisions, says cross country coalition.

Europe Coronavirus COVID-19

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

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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

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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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