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Policy & Regulation

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From Rare To Real: Pharma Urged To Act As China Preps New Rare Conditions List

Chinese regulatory agency working around the clock in preparation to release another official list of rare diseases, and a push to launch more innovative orphan drugs is underway. But this time pharma firms need to be more proactive, noted an NMPA official.

China Rare Diseases Research and Development Strategies

Regulation

Set Alert for Regulation

Latest From Regulation

Canada Introduces eCTD To Ease Clinical Trial Filings

Filing for clinical trial activities in the electronic common technical document format via the Common Electronic Submission Gateway is expected to help sponsors send their information in a secure manner, with reduced transmission times and cost.

Canada Clinical Trials

Ireland Embarks On New Stage Of Drug Verification System

The bedding-in period is ending for Europe’s one-year-old system for preventing the circulation of fake medicines, and the scheme is gearing up for a more fully operational stage. 

Ireland 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

EU Accelerated Assessment Tracker

EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.

Europe Drug Review

Regulatory Measures Could Mitigate Coronavirus Risks In Europe

As part of its response to the coronavirus outbreak, the European association representing generic and biosimilar drug companies, Medicines for Europe, has set out a series of policy recommendations that it says could help to mitigate the possible risks to medicines supply.

Regulation Europe

US FDA Still Seeking Sponsor Cooperation For Oncology Label Updates

Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.

Generic Drugs Cancer
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Policy

Set Alert for Policy

Latest From Policy

Joint Tendering Creates ‘Attractive Nordic Market’

Joint tendering among Nordic countries can help reduce shortages of older, off-patent medicines. 
Europe Denmark

Rx List Price Inflation Penalty Endorsed By US HHS Secretary

Senate Finance Committee’s approach to penalize companies for raising WAC list prices is not a ‘price control,’ but a reasonable approach to change the incentives that distort pricing in the supply chain, US HHS Secretary Alex Azar says.

Legislation Medicare

Balancing Act: China Approves Antiviral For Coronavirus While Promoting Traditional Medicines

Amid the ongoing spread of the coronavirus outbreak, China turns to novel and repurposed antiviral drugs but also courts traditional medicines to ease public fear over the largely unknown threat.

China Approvals

Could ICER Outreach To US FDA Lead To Better Cost Effectiveness Analyses?

To aid its value assessments, ICER is interested in helping FDA understand the importance of patient-relevant outcomes and consistent endpoints across trials of drugs for the same disease.

Health Technology Assessment Comparative Effectiveness

Two Companies, Two BARDA Contracts, Two Approaches To Coronavirus

Sanofi follows Janssen in teaming up with HHS' BARDA to develop a COVID-19 vaccine; using technology platform of its Flublok vaccine, Sanofi expects to enter clinical trials in 1 to 1 ½ years.

Vaccines Infectious Diseases

Medicare-For-Hmmm: A Year Of House Hearings Show Democratic Disunity

Four House hearings show how far away even many Democrats are from supporting a single payer system in the US.

Medicare Pricing Debate
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