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Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

Long Serving Deputy Becomes China Health Commissioner

China's third-ranked health official Ma Xiaowei has been promoted to the top position, leading an agency transforming itself from treating diseases to health policy-making against a backdrop of a fast-aging population, emerging data and new AI technologies.

Appointments Asia Pacific

Korea Revises Rules To Curb Rebate Activities, Improve Ethics

South Korea continues efforts to root out illegal rebate payments for drugs and to step up the pharma industry's ethics and social responsibility by revising relevant rules, but in a way that doesn't harm patients' health.

Regulation Reimbursement

Tougher Sanctions And Penalties Kick In For Advertising Breaches In Australia

Australia has introduced new civil penalties and amended criminal offence provisions for breaches of its therapeutic product advertising rules. More reforms to the advertising regulations are expected soon.

Advertising, Marketing & Sales Regulation

Goodbye CFDA, Hello MRA: China Overhauls Regulatory Bodies

China proposes to merge its top drug regulator into new combined body, and creates a medical reimbursement agency in move viewed as sign of strengthening regulatory oversight.
Reimbursement Regulation

Opdivo, Keytruda Hit Again As Japan Revises Prices

Immuno-oncology drugs Opdivo and Keytruda will have their prices cut in the next regular Japanese price revision in April, while some other novel and big-selling products will also feel the heat under a revised framework.
Japan Reimbursement

GC Pharma/Biocon Eye Low Price Strategy As Biosimilar Insulin Glargine Approved In Korea

GC Pharma/Biocon are set to adopt a low price strategy for their biosimilar insulin glargine, which has just received regulatory approval in South Korea, to better compete with rival products.

Approvals Biosimilars
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Set Alert for Europe

Latest From Europe

Clovis Confident, Portola Not: CHMP Decides On EU Marketing Applications

Eight EU marketing authorization applications are up for an opinion this week from the CHMP, the European Medicines Agency committee that recommends whether or not products should be approved.

Drug Review Approvals

Products For Cystic Fibrosis, VWD & Schizophrenia Nearing End Of EU Review

The European Medicines Agency's CHMP is expected this week to adopt Lists of Outstanding Issues on products for von Willebrand disease, cystic fibrosis and schizophrenia.
Europe Drug Review

Risk-Based Contamination Limits Suggested For Highly Potent Drugs

As more highly potent and highly toxic drugs are being developed, regulators are looking into risks posed by contamination of non-contact surfaces, yet until recently, there was scant guidance on how to assess these risks.

Europe United States

UK Price Scheme Changes To Cost Pharmaceutical Industry £33m

The government is expecting to reap UK-wide savings of £33m by basing the statutory drug pricing scheme on regular payments on sales rather than price cuts and limiting the maximum prices companies can charge the NHS. The move will bring the scheme more into line with the voluntary PPRS.

Pricing Debate Policy & Regulation

GSK Adds £50m Per Year To Brexit Cost Estimates

Brexit is likely to cost GSK around £50m a year in the form of customs duties and transaction and administration costs. It is one of a handful of companies to have made its cost estimates public.

Brexit Regulation

New MHRA Guideline Could Be Global Pharma's Go-To Standard For GxP Data Integrity

The UK regulator has done a good job of aligning its final data integrity guideline with those of other international bodies, which means global drug companies will not have to balance competing requirements to achieve compliance, says consultancy firm Rammell. However, some aspects of the guideline, such as following a risk-based approach, could pose some challenges.

Regulation United Kingdom
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United States

Set Alert for United States

Latest From United States

Orphan Drug Development: Could We Be Seeing The End Of P Values?

Panel of experts stresses need to move toward innovative approaches for rare disease drug development such as Bayesian methods, but this would require a paradigm shift in US FDA's regulatory structure. 
Clinical Trials Rare Diseases

CHPA Eyes Spanning Self-Care Space With Bridge To Device Sector

Many CHPA members also market medical devices "and the consumer side of medical devices is something they feel is underrepresented by other trade associations,” says trade group head Scott Melville. OTC drugs already have “a lot in common” with consumer medical devices, including that paying for neither typically is included in health insurance plans.

Consumer Prescription To Otc Switch

Opioid Spotlight: Trump Announces Plans For More Spending As Congress Introduces Two Dozen Bills

Administration also plans to roll out slate of proposals to decrease drug prices and bring discounts to patients.

Legislation Neurology

US FDA Pushes Back On Proposal For Early Clinical Designations To Support Higher Reimbursement Decisions

Breakthrough, RMAT designations signal clinical potential and are not intended to have reimbursement impact after approval, FDA says. 
Review Pathway Reimbursement

Drug Safety: Sequential Surveillance Helps Regulatory Decision-Making, But Hurt By Premature Specification

US FDA and academic researchers say unknowns related to certain product aspects make it difficult to form a hypothesis in formal sequential surveillance designs.
Drug Safety Post Market Regulation & Studies

Patient Experience Data: Industry Seeks US FDA Clarity On Submission Pathway And Labeling

Dedicated mechanism may be needed for biopharma sponsors and patient advocacy groups to talk to agency about patient experience data collection and analysis; industry wants FDA to clarify where such data will appear in product labeling, while advocates ask agency to be mindful of limited resources many patient groups have for conducting such research.

Drug Approval Standards Rare Diseases
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