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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.

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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'

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

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

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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?
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  • Will I get approval for my product?
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Insight Beyond The Sound Bite
2016's Top Interview Exclusives
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
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
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.
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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
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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
View the Full Infographic