Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Policy & Regulation

Set Alert for Policy & Regulation

The Budget Blindside: Did Pharma Fight The Wrong Battle?

The bigger 'Donut Hole' discount is a rare loss for pharma on Capitol Hill – one that may in part be because industry did too good a job fighting off a different drug pricing measure.

Medicare Generic Drugs Legislation

EU Regulators Urge Pharma To Share Their Brexit Plans

Sponsors of medicines evaluated through the EU's decentralized procedure are being urged to share their plans regarding Brexit with national agencies as soon as possible to help with planning. The head of the Dutch Medicines Agency thinks that the human medicines sector can learn from the progress being made in the veterinary space on this front.

Brexit Regulation Europe


Set Alert for Regulation

Latest From Regulation

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

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

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

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
See All


Set Alert for Policy

Latest From Policy

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

One-Third Of Payers Preferred Biosimilars Over Reference Drug in 2017

As biosimilar uptake remains modest, rebate amounts trend upward for medical benefit drugs, according to latest MagellanRx drug trend report.

Biosimilars Pricing Strategies

Shire, Microsoft and Eurordis Partner To Improve Diagnosis And Treatments For Rare Disease

An alliance between Shire, Eurordis and Microsoft to speed up diagnosis of rare diseases in children could lead to better access to treatments and the development of new medicines.

Market Access Policy

340B Hospitals May Be Losing Transparency Debate In Congress

Biopharma industry's arguments on rebate pass-through to patients appear to carry the day at Senate HELP Committee hearing.

Pricing Debate Legislation

Oncologists Charge More Than Other Specialties For Same Drugs, Study Finds

Oncologists charge at least 50% more for Lupron and Aranesp than do urologists or nephrologists, researchers with Johns Hopkins and Memorial Sloan Kettering found.

Pricing Debate Policy
See All