Pink Sheet is part 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

UsernamePublicRestriction
UsernamePublicRestriction

Latest News & Analysis

Real-World Evidence Study Registration May Help Drive FDA Acceptance

US FDA’s David Martin encourages sponsors to register observational studies on drug effectiveness to enhance transparency and agency confidence in the data.

Regulation Real-World Evidence

Opioid Trial Preview: The Claims, Defenses, And Last-Minute Maneuvers

Trial opens after settlement proposals by three distributors, Teva and J&J fail to gain support of cities and counties. Distributors want to call former FDA Commissioner Kessler to testify over plaintiffs' objections. Judge rules plaintiffs cannot seek future damages.

Legal Issues Advertising, Marketing & Sales

Infographic: A Decade Of Opioid Lawsuits And Settlements

A timeline of the history of opioid litigation from Purdue Pharma's 2007 settlement to the bellwether trial in Ohio.

Legal Issues Enforcement

Medicare Part D Redesign Backed By House Republicans Retools Manufacturer Discount

Offered as a failed amendment by House Energy & Commerce Committee’s ranking Republican during markup of Speaker Nancy Pelosi’s drug pricing bill, the proposal is in line with biopharma’s position on manufacturer price concessions in Part D and suggests a road map for the kind of bill that might pass the Senate.

Legislation Medicare

Keeping Track: A Novel Approval For Fluorodopa F 18, A Tentative Approval For Vumerity, And A Missed Goal Date For Zilretta

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Risk-Based Approach To Protecting Data Integrity Outlined In Forthcoming PDA Report

An upcoming PDA technical report is expected to build on the concepts of an earlier report on laboratory systems and propose a risk-based approach for protecting data integrity using a nine-box grid for assessing data integrity risks.

Manufacturing Quality

First Ebola Vaccine Among Seven Products To Get EMA Nod

Seven new products, including the world’s first ever Ebola vaccine, are on track to receive EU-wide approval. Meanwhile, two drugs have failed to make the grade.

Approvals Europe

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

New Italian Pricing Decree To Drive R&D Transparency

Following on from moves to push price transparency on to the global agenda, Italy is poised to pass a decree that would oblige companies to disclose public R&D funding.

Europe Italy

UK Signs Three More No-Deal Brexit Drug Transport Contracts

Efforts to ensure that supplies of medicines continue to flow if the UK leaves the EU without a deal have been stepped up with the announcement of three contracts to provide an express delivery service for urgently needed products.

United Kingdom Brexit

ANDA Reviews Sometimes Miss GDUFA Goal Dates To Get Quicker Approval, But How Often?

Preliminary performance data suggests only a handful of applications receiving US FDA action by the end of FY 2018 actually missed their review goals.

Generic Drugs Review Pathway

Top US FDA Officials Continue To Lament Advisory Cmte. Recruitment Difficulties

Strict conflict of interest rules have hampered the agency's ability to fill advisory committee vacancies.

Advisory Committees FDA
See All
UsernamePublicRestriction

Register

Advertisement