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Featured Stories


ICER’s Biopharma Members: Why They Joined And What They Get

Biopharma’s funding support for the Institute for Clinical and Economic Review has been slightly above that of payers and providers for the past three to four years.

Health Technology Assessment Reimbursement Pricing Strategies

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 China

Pharmacogenetic Tests: US FDA Tries Off-Label Approach To Guide Consumers

US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.

Personalized Medicine Regulation FDA

Spotlight On Drug Pricing

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Performance Trackers

Keeping Track: Quick Trips From Breakthrough Designation To Market

Phase III data earns a breakthrough therapy designation for Resverlogix’ apabetalone; previous companies to follow that strategy swiftly advance to NDA submission, as seen with Novartis’ capmatinib and Seattle Genetics’ tucatinib.

US FDA Performance Tracker Drug Delivery Review Pathway

Global Pharma Guidance Tracker – January 2020

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 Regulation Europe

Policy & Regulation Explore this Topic

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Latest From Regulation

US FDA Tech Modernization Plan’s Costs Uncertain

Agency officials determining needs using existing budgets before requesting more funds and will engage with tech investors for design advice.

Cybersecurity Drug Review

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

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

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

Clinical / R&D Explore this Topic

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Latest From Research & Development

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

US Researchers Working Toward Universal Coronavirus Vaccine

The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.

Vaccines Manufacturing

Novel Ticagrelor Reversal Agent Wins Place On EMA’s PRIME

Only two of seven recent applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical needs to patients faster made the grade.

Europe Regulation

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Latest From Commercial

Japan 2010s In Review: Specialize, Focus, Innovate

Reimbursement issues continued to dominate the policy sphere in Japan during the last decade, while new forms of therapy benefited from positive regulatory reforms. Meanwhile, consolidation and specialization were major threads running through the corporate sector.

Japan Reimbursement

At Muted J.P. Morgan, Focus Is Execution, But US Pricing Is Persistent Overhang

Political worries aside, industry is confidently executing on focused strategies as it welcomes a new decade, even if a lack of deal news at the J.P. Morgan Healthcare Conference didn't excite investors.

Pricing Debate Business Strategies

J.P. Morgan Notebook Day 4: Novartis CEO Weighs In On AI, Sangamo’s Next Steps And More

Additional highlights from the J.P. Morgan Healthcare Conference, including Takeda’s partnering outlook, Sage’s guidance on Zulresso sales, Frequency’s next steps for its hearing loss drug and Revance’s preparations to take on the aesthetics market. 

Business Strategies Artificial Intelligence

Manufacturing Explore this Topic

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Latest From Manufacturing

EU GMP Annex I Proposal Would Maintain PUPSIT, Relax WFI Restrictions

The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.

Manufacturing Quality

Cleveland Clinic Drug Quality Dashboard Helps Guide Product Choices

After realizing some generics don’t work, academic medical center screens quality by manufacturer. Other providers protest: It’s not our job.

Manufacturing Quality

Providers Support FDA Quest For Public Drug Manufacturing Quality Ratings

Agency agrees with those who prescribe and buy drugs on need to incentivize quality. Except providers want it yesterday.

Manufacturing Quality
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