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Regional Coverage

Asia Pacific

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Latest From Asia Pacific

US FDA’s Project Orbis Could Streamline Global Clinical Trials In Cancer

Richard Pazdur tells the Pink Sheet that program for concurrent submission of oncology applications and collaborative review by global regulators also could speed approval in smaller countries; first applications under Project Orbis were for use of Lenvima/Keytruda combination for endometrial cancer in US, Canada, and Australia.

Drug Review Review Pathway

Regulatory Digital Savvy: Taking China NMPA's New App For A Test Drive

At just the time when pretty much everything is going digital in China, the nation’s pharma regulatory agency has launched a new mobile application to put itself at your finger tips. And it’s time to give it a test drive.

China Regulation

Global Pharma Guidance Tracker – August 2019

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents International

China's New Pharma Law Leaves Key Questions Unanswered

Much anticipated legislation signals flexibility over online sales of pharma products and definition of counterfeits, but the law also falls short on key elements of pharmaceutical innovation and intellectual property rights protection, says one legal expert.

Legislation Regulation

Australia’s TGA Considers “Commercial Sensitivities” In Excipient Naming Proposals

The Therapeutic Goods Administration says consumers are frustrated that they cannot easily access information on excipient ingredients through existing mechanisms.

Australia Regulation

US FDA Slams CTX Lifesciences Again For Lax Failure Investigations

The FDA wants to know why the API firm is still not getting to the root cause of manufacturing deviations.

Manufacturing Quality
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Europe

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Latest From Europe

EMA OKs Seven New Drugs But Delivers Another Blow To Emmaus

Seven new drugs have this week moved closer to gaining EU approval following positive recommendations from the European Medicines Agency, but Emmaus’ glutamine product has fared less well and the company is considering another route for getting the drug to sickle cell disease patients in Europe

Europe Drug Review

Longer Medicine Supply Delays Expected In No-Deal Brexit

Delays in the delivery of medicines with short lead times will be longer than originally expected in the event of a no-deal Brexit, UK health care providers have been warned.

United Kingdom Brexit

‘Biased Trials Undermine EU Cancer Drug Approvals’

Nearly half of the pivotal randomized controlled trials supporting European marketing authorizations for new oncology drugs are at high risk of bias, claims a new study.

Europe Clinical Trials

Novartis Wants More Time To Answer EMA’s Zolgensma Questions

Novartis unit AveXis is one of several companies seeking extra time to address questions the European Medicines Agency has regarding their marketing applications. The company says it could get a decision on whether the product should be approved in the EU by year-end.

Europe Drug Review

Keep It Simple: EU Consults On Future Design Of EMA’s Fee System

Following a report that identified several shortcomings of the European Medicines Agency fee system, the European Commission has suggested various options to make it sustainable and future-proof.

Europe Regulation

Industry Still Awaiting Clarity On Brexit Supply Chain Arrangements

As the Brexit clock continues to tick, industry says it is not impressed by government reassurances that all is well where the continued supply of medicines is concerned.

Brexit Trade
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United States

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Latest From United States

US FDA IT Modernization Plan Will Lay Groundwork For Real-Time Data Submissions

Principal deputy commissioner Amy Abernethy cites IND safety reporting and oncology review pilot program as areas that would benefit from enabling receipt of sponsor data in real time; plan describes near-term strategy for modernizing agency’s technical infrastructure, developing technology tools around regulatory ‘use cases’ and improving collaborations with data and tech companies.

Artificial Intelligence Cybersecurity

Keeping Track: A Duo Of RTOR Approvals, Thumbs Up For First Oral GLP-1 Treatment, And First Ebola Vaccine Nears US Market

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

US FDA Performance Tracker Approvals

Pink Sheet Podcast: US FDA Launches Project Orbis And The Rare Disease Cures Accelerator, Looks For Abuse-Deterrent CNS Drugs

Pink Sheet reporters discuss the US FDA's work with other countries to review and approval of cancer therapies at the same time, a new database for rare disease clinical trial and natural history data, and the agency's exploration of abuse-deterrent CNS stimulants.

Drug Review Rare Diseases

Senate Wants Priority Review For 'Deemed' Biologics Not Approved By Deadline

Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.

Biologics Legislation

FDA: Key FY 2019 Warning Letter Trend Is Inadequate Testing For API Impurities

This year’s 89 warning letters so far hit API testing for nitrosamines, aseptic facility design, contaminated water, API traceability and more.

Manufacturing Quality

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
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