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Pink Sheet
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Beyond The Horizon Insight
With the constantly evolving biopharmaceutical regulatory environment, it’s hard to stay on top of business-critical developments.

But Pink Sheet’s team of analysts across Washington DC, Europe, and Asia Pacific is uniquely positioned to deliver the insight advantage you need to navigate the complex world of legislation and policy, regulation, and compliance.

When you need “beyond the horizon” analysis to support strategic planning, count on Pink Sheet for:
 
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Comprehensive Coverage
For An Insight Advantage
Featuring coverage from more than 20 contributors, Pink Sheet is produced by the veteran journalists and analysts behind legacy Pharma Intelligence publications The Pink Sheet, The Pink Sheet Daily, The Gold Sheet, The Tan Sheet, The RPM Report, and Scrip Regulatory Affairs.

If you have an active subscription to any of these titles, you now have access to all of the content in all six products through Pink Sheet.
A Unified Portfolio
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The new Pink Sheet benefits from a truly global footprint, delivering deeper coverage of all aspects of prescription and over-the-counter drug policy and regulation to help you make smarter decisions and achieve a competitive edge in an at times, unpredictable industry.
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Enhanced multimedia features such as video, audio, and infographics bring our analyses to life, while article pages suggest related content for further reading to save you time.
 
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The Year In Preview

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A shake up at the FDA?
You may rely on it.
"President Trump is not following the standard playbook and promises big changes to the US regulatory system, including FDA. His selection to run the agency will set the tone for any changes he intends to make."
- Derrick Gingery, Senior Writer

Read More > Trump Takes Office, Change At US FDA Arrives With ‘Beachhead Teams'

 
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A pivotal year for US biosimilars?
It is certain.
"Key to look out for will be: the FDA's implementation of the biosimilars pathway under the Biologics Price Competition and Innovation Act, decisions on at least four pending biosimilar applications with user fee goal dates during the year, and data guidance to support an interchangeability determination."
– Sue Sutter, Senior Editor

Read More > Biosimilars In 2017: Crowded US FDA Review Queue, Key Legal Decisions

 
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Implementation of expedited approval schemes?
Outlook hazy.
"How will drug makers make the most of schemes for speeding access to drugs for unmet medical needs? One key I can predict is companies needing to involve more of their internal functions than normal early on in development."
– Neena Brizmohun, Deputy Editor

Read More > A Candid Behind-The-Scenes Look At PRIME with Novimmune & Biogen

 
Free Article Pack
Biopharma's Top Approval Themes of 2016
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2016 U.S. approvals:
2016 EU approvals:
2016 Japan approvals:
 

Pink Sheet Has Your
Big Questions Covered
  • What socio-political changes are impacting the regulatory process in this country?
  • What are the barriers to entry for this drug?
 
  • How should my trial be designed to gain approval?
  • Who are the thought leaders and influencers in this space?
 
  • Will I get approval for my product?
If you find you need further answers, your Pink Sheet subscription gives you access to our pool of analysts who can dig deeper to deliver the insight you need.
 
Insight Beyond The Sound Bite
2016's Top Interview Exclusives
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Mark McClellan & Gregory Daniel,
Margolis Center for Health Policy

The Center's director and deputy director, respectively, discuss their move from Brookings to Duke, the breadth and impact of their work with the FDA, and potential future collaborations with the agency.
Read Interview
 
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Bernhard Schwartländer,
World Health Organization

Despite widespread concern over China's economy and regulatory environment, WHO's top representative in Beijing calls for deeper engagement with the country.
Read Interview
 
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Janet Woodcock,
Center for Drug Evaluation & Research Director

30-year FDA veteran discusses role in shaping CDER into a mammoth scientific and policy headquarters for drug development.
Read Interview
 
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Yann Le Cam,
CEO of the European Organization for Rare Diseases

Eurordis head outlines his vision to reform "crazy" European orphan drug pricing system.
Read Interview
 
Ask The Analyst™
Learn About Pink Sheet's Analyst Support Service
For Your Biopharma Regulatory Questions.

Consultancy Value With Every Pink Sheet Subscription.
Ask The Analyst™ is the bespoke analyst support service of Pharma Intelligence, included in all Pink Sheet subscriptions.

With it, subscribers submit specific questions about news stories, biopharma policy trends, or regulatory issues to our analyst team and receive data-driven, actionable insight within days.

It’s consultancy value rolled into a convenient news and analysis solution.
Ask The Analyst
Pink Sheet Ask The Analyst™
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Spend less of your own time unravelling the critical regulatory, legislative, legal, and financial changes affecting biopharma, and more time applying Pink Sheet insights to your forward-looking strategies.
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Track FDA Drug Approvals
With Ease And Accuracy.

Pink Sheet Makes It Possible.
Conduct competitive intelligence with greater ease and precision with eight, exclusive datasets.
Pink Sheet gives its subscribers unprecedented visibility into important milestones in the drug review process through FDA Performance Tracker, an exclusive suite of interactive charts curated by our editorial staff.
User Fee Goal Dates Tracker
Pink Sheet FDA Performance Tracker
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Free Article Pack
From Pink Sheet:

The Path To A New Priority Medicine Scheme in Europe
Foretelling The News.
Extracting the Insights.
When Europe announced a new priority scheme for innovative drugs, we helped subscribers stay ahead of the headlines and interpret the breaking news.
  1. Faster EU Drug Assessment Pathway Could Launch In First Quarter 2016
  2. EEMA Defends PRIME's Early Entry Advantage For Smaller Companies
  3. EMA's New PRIME Scheme Gets 18 Applications In First Month
  4. First EU PRIME Designations Go To Biogen, ChemoCentryx, Kite, NovImmune
  5. FDA's Breakthrough Bar May Be Set Too Low, Jenkins Says
  6. EMA's PRIME Scheme: Why Nearly Four Out Of Five Fail To Make The Grade
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