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Latest News & Analysis

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

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

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

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

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

IND Safety Reporting: Stakeholders Tussle Over Which Adverse Events To Report, Proper Oversight Body

US FDA officials, drug sponsors discussing creation of library of adverse event rates.

Drug Safety Regulation
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