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Latest News & Analysis

EMA 'Completely Reworks' Parts Of Gene Therapy Products Guideline

The European Medicines Agency has revised several sections of its 2001 guidance on the development and evaluation of gene therapy medicinal products based on stakeholder feedback and to address issues in light of the experience gained with these products.

Europe Regenerative Medicine

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

European Performance Tracker Drug Review

UK Regulator Considers Jail For Non-Compliance With Coming EU Safety Features

The Medicines and Healthcare products Regulatory Agency has issued for consultation proposals on how it will ensure the UK meets its obligations to transpose the safety feature provisions of the EU Falsified Medicines Directive.

Drug Safety Distribution

Novartis And Cohen: A View Into Pharma's Policy Concerns As Trump Took Office

As then-Novartis CEO Joe Jimenez worked with former Trump lawyer Michael Cohen on drug pricing issues, the pharma industry was preparing for the debate it's eventually getting to have.

Pricing Debate Regulation

Medicare Reimbursement For New Part B Drugs Lowered In Proposal

New specialty drugs will get lower interim payments from Medicare under proposed rule.
Regulation Medicare

Sharing Information With US FDA Advisory Committee Can Invalidate Patent, Jazz Finds

Federal Circuit rules that material about Xyrem's REMS distribution system provided for advisory committee review constitutes prior art.

BioPharmaceutical Policy

Beyond Rebates: PhRMA Wants HHS To ‘De-Link’ Supply Chain Compensation From List Price

Focus should not be limited to rebates in Medicare Part D, manufacturers advise in comments on HHS drug pricing blueprint. Pharmacy benefit managers raise anti-trust issues with shift to upfront discounts.

Pricing Debate Pharmacy Benefit Management

FDA Shortages Task Force Looks More Broadly To Tackle Root Causes

FDA’s latest drug shortages task force aims to encourage investment in the reliable manufacture of generic sterile injectables that are fundamental to the practice of medicine. While the agency’s first task force continues to work with industry to avert shortages, the second will strike at underlying structural issues that cause persistent shortages of these critical medicines.

 

United States Manufacturing

Celgene, Agios Drug Enasidenib Among New Filings At EMA

Enasidenib, which last year became the first US-approved treatment for relapsed or refractory acute myeloid leukemia with an IDH2 mutation, is among a new crop of products being reviewed for marketing approval in the EU.

Drug Review Review Pathway

Canada Makes It Mandatory For Pharma To Report Overseas Safety Actions

Canada claims to be the first country to issue formal regulations that make it mandatory for drug companies to report within strict timelines safety issues related to their products in certain foreign jurisdictions.
Canada Drug Safety

Hemophilia Gene Therapy Studies Could Use Non-Inferiority Design, US FDA Suggests

Development guidance from CBER recommends comparing investigational gene therapy products to existing prophylaxis treatment.

Biologics Blood & Coagulation Disorders

GSK's Tafenoquine Faces Questions Over Review Pathways At US FDA Panel

Advisory committee questions about malaria drug’s breakthrough therapy and orphan drug designations reflect lingering confusion about how agency’s various regulatory pathways impact product development and approval.

Advisory Committees Drug Review
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