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Featured Stories


FDA Broke Catalyst's Orphan Exclusivity Due To Pricing, Not Clinical, Concerns, Firm Claims

Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).

FDA Legal Issues Drug Approval Standards

UK MHRA Looks Beyond Brexit Transition

Now that the UK has left the EU, the UK’s medicines regulator says it will use the rest of this year to work out how best to ensure continuity of drug regulation after the Brexit transition period ends on 31 December.

Brexit Regulation Drug Safety

Pharma Enforcement Remains 'Priority Area' In FTC's 2021 Budget Request

US Federal Trade Commission has mainly focused in pay-for-delay cases over the past decade, but pricing strategies are an emerging area of attention; industry is paying close attention to potential enforcement in biosimilar market.

Enforcement Legal Issues Policy

Spotlight On Drug Pricing

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Performance Trackers

Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza

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

US FDA Performance Tracker Approvals Drug Review

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

Set Alert for Policy & Regulation

Latest From Regulation

EU And US Orphan Drug Regimes: Benefits And Limitations Of International Cooperation

Daniel Kracov and Jackie Mulryne analyze the differences in data requirements for the authorization of orphan medicines in the EU and the US and the challenges they pose for global drug development.

Rare Diseases Europe

Potential Cardiovascular Blockbuster Inclisiran Among New Filings At EMA

The European Medicines Agency has agreed to review pan-EU marketing applications for a number of new medicines.

Europe Approvals

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

FDA Requests Belviq Be Pulled From The US Market Due To Cancer Risk

The agency requested the weight loss pill be voluntarily recalled by Eisai, the death knell for a trio of obesity drugs that launched early in the last decade. 
Metabolic Disorders Drug Safety

EU Speedy Review Success For Kite But Not For Lilly

KTE-X19, Kite’s potential new CAR-T therapy, will in the end be fast-tracked at the European Medicines Agency. Lilly failed to secure the speedy review it was seeking for selpercatinib

Drug Review Europe

EU Parliament Urges Post-Brexit Cooperation On Medicines

Life science companies will be pleased to hear that the European Parliament is pressing for close cooperation between the UK and the EU in the area of medicines regulation.

Brexit Europe

Latest From Policy

Sanofi Tries To Stop Lantus Biosimilar By Getting Supreme Court To Review PTAB, Again

Sanofi seeks to delay decision clearing path for Mylan's Lantus biosimilar; says it should be able to get rehearing based on Federal Circuit's ruling that PTAB judges were not constitutionally appointed.

Legal Issues Intellectual Property

Sanofi Improperly Listed Lantus Patent In FDA's Orange Book, Appeals Court Finds

First Circuit reverses dismissal of direct purchasers' suit alleging improper listing of patent on device drive mechanism delayed competition; district court to decide if this constitutes antitrust violation.

Legal Issues Intellectual Property

Scotland Recommends Interim Funding For Regeneron/Sanofi’s Libtayo

Patient access schemes have helped the Scottish Medicines Consortium recommend rare disease products, including Regeneron/Sanofi’s Libtayo for skin cancer.

Europe United Kingdom

Clinical / R&D Explore this Topic

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Latest From Research & Development

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

For Coronavirus, US FDA Is At The Podium But Not On The Task Force

The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.

FDA Infectious Diseases

Commercial Explore this Topic

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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

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

UK Firms Asked To Check Coronavirus Supply Chain Impact

Amid concerns that the coronavirus outbreak could have an impact on the supply of APIs and other materials sourced from Chinese manufacturers, pharmaceutical companies are to assess their supply chain situation to help ensure patients do not experience medicine shortages.

United Kingdom Manufacturing

Industry Applauds US FDA Plans For Novel Excipients Review Pathway, But Urges Refinement

The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.

Manufacturing Quality
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