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Pink Sheet Perspectives

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A Decade Of Novel CDER Approvals, By The Numbers

Pink Sheet infographic illustrates new drug approval trends and highlights from the past decade at the US FDA. 

Approvals Drug Review Pink Sheet Perspectives

Latest From Pink Sheet Perspectives

Vaccines Boost Priority Profile Of US FDA’s Biologic Center 2019 Approvals

Tropical diseases were not neglected by the Center for Biologics Evaluation and Research in 2019, producing three novel vaccines (which earned three priority review vouchers) and tilting the approval class toward expedited review programs.

Vaccines Pink Sheet Perspectives

Neuroscience Challenges Oncology For Top Spot In CDER’s 2019 Novel Approvals

Oncology R&D isn’t waning, but investment in neurology and psychiatry drug development are paying off in new drug approvals. Rapid growth in CDER non-malignant hematology approvals reflects longer, broader trend toward orphan drugs.

Review Pathway Pink Sheet Perspectives

Decade In Review: Biopharma's Shifting Legal Landscape

Emergence of the inter partes review process dramatically changed the patent dispute arena.  The decade also brought biosimilar litigation, generic price-fixing complaints, opioid lawsuits and new government investigations and antitrust actions.

Legal Issues Biosimilars

US FDA's Decade In Review: From Biosimilars To Real-World Evidence

A look back over FDA actions during the past 10 years shows the evolution of its policies on opioids, preemption, off-label promotion and use of real-world evidence.

FDA Biosimilars

A Visual Guide To US FDA's Evolutionary Decade In Review

An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.

FDA Regulation

EU 2019 Approvals: Novel Therapies Make Strong Showing

Bluebird bio’s gene therapy Zynteglo, Akcea’s antisense drug Waylivra and BioMarin’s enzyme substitution therapy Palynziq were among the novel innovative medicines that were approved in Europe in 2019. 

Europe Approvals

Pink Sheet Podcast: The Most Impactful Stories Of 2019

Pink Sheet reporters review the major issues that emerged during the past year and how they will impact 2020.
FDA Leadership

US FDA’s Breakneck Approval Pace Clashes With Advisory Committee Mandate

FDA has approved more than 100 novel molecules in the past two years, almost all of them without an advisory committee stop. Is it time to revisit a 2007 law that was intended to assure a public vetting of NMEs prior to approval?

Advisory Committees Drug Review

CRLs In 2019: Steady In Number, But Biosimilar Performance Improves

The US FDA issued at least 33 complete response letters to sponsors in 2019, although only one went to a biosimilar candidate.

Complete Response Letters Drug Review
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