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


Drug Safety

Set Alert for Drug Safety

Latest From Drug Safety

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

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

CTI's Approval Prospects For Pacritinib In Myelofibrosis Look To Be Improving

Firm publishes final data from a Phase III study showing the safety-troubled JAK2/FLT3 inhibitor performs better than Jakafi in reducing spleen size. Ongoing dose-finding study will determine the regulatory path forward.

Drug Review Clinical Trials

Second EMA Public Hearing To Focus On Quinolone, Fluoroquinolone Side Effects

The European Medicines Agency wants to hear testimonies from the public about serious side effects that have been observed in patients treated with quinolone- and fluoroquinolone-containing medicinal products.

Drug Safety Post Market Regulation & Studies

Pregnancy Labeling Needs Clearer, More Consistent Language, US FDA Panel Says

Language used to describe drug effects on pregnancy and lactation is ambiguous, complex and not useful to prescribers, advisors say, also urging FDA to use graphics or rating scales to convey the strength of the animal and human data on use during pregnancy.

Advisory Committees Drug Safety

Biosimilar Switching Studies Show No Adverse Efficacy Or Safety Effects, Researchers Say

Sandoz-led review of 90 published studies finds no evidence to support theoretical concern about differences in immunogenicity when switching between reference biologics and their biosimilars; findings could instill more public confidence about biosimilars in US and reduce importance of an interchangeability designation from FDA.

Biosimilars Biologics

EMA Calls For Zinbryta's ‘Immediate’ Suspension After More Reports of Brain Disorders

Biogen/AbbVie’s Zinbryta is already being withdrawn worldwide, but EMA now wants the MS drug recalled after mounting reports of serious brain disorders.

Drug Safety Europe

The Zinbryta Withdrawal And The Limits Of US FDA’s Proactive Communication

FDA is getting justifiably high marks for its efforts to accelerate drug development, and the proactive communication approach of Commissioner Gottlieb is a big part of that dynamic. But a drug safety withdrawal could be a sign of trouble ahead, if the perception takes hold that Europe is more proactive when it comes to patient safety.

Drug Safety Neurology

Zinbryta Global Withdrawal Driven In Part By Difficulty Of Safety Assessment

EMA safety investigation pushes decision as AbbVie, Biogen acknowledge 'characterizing the evolving benefit/risk profile … will not be possible going forward given the limited number of patients being treated.'

Drug Safety Neurology
See All