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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

U.S-China Trade War Heats Up; Should Health Sector Start Worrying?

As US prepares new tariffs, industry tries to to stay optimistic about business prospects in China.

Intellectual Property Trade

Australia Clarifies Regulatory Oversight Of Human Tissues And Cell Products

New rules on the regulation of autologous human cell and tissue products have been introduced in Australia, together with clearer definitions of biological products.

Biologics Australia

Janssen’s Apalutamide First To Gain Approval Under International Work Sharing Program

The ACSS Consortium’s work-sharing pilot for new drugs has yielded its first twin approval, for Janssen’s prostate cancer treatment, apalutamide.
Approvals Regulation

Meet China SDA's New Deputy Commissioner: A Regulator With Strong US Connections

The third highest-ranked drug regulatory official in China will bring years of legislative and regulatory experience, along with US education and extensive training, to the table.
China Regulation

EU Regulators Recall Valsartan Products Produced In China

Stada and Accord are among the companies affected by an EU wide recall of valsartan manufactured by a Chinese supplier.

Europe China

J&J Divests OTC Anti-Dandruff Product To Separate Buyers Across 3 Regions

J&J agrees to sell marketing rights to its OTC 1% ketoconazole dandruff treatment product to Kramer Labs in the US and Latin America, to German firm Stada in the EMEA and to UK firm Alliance Pharma for the Asia-Pacific market as it continues to spin off non-core brands and focus on its core $1bn brands.

Consumer Deals
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Europe

Set Alert for Europe

Latest From Europe

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

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

UK NICE Knock Back For Janssen’s ‘Game-Changing’ Darzalex Combo

Draft guidance from the health technology assessment body, NICE, says that while Darzalex in combination with two other drugs is an innovative therapy for previously treated multiple myeloma, there is not enough long-term data to support its use on NHS England.

Health Technology Assessment Reimbursement

Long-Awaited Brexit White Paper Lays Out UK’s Plans For Medicines Regulation

The UK government has finally published its white paper on the UK’s future relationship with the EU following Brexit, to the relief of the pharmaceutical industry.
Brexit Regulation
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United States

Set Alert for United States

Latest From United States

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

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

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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