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Latest News & Analysis

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

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

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BioPharmaceutical

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

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

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

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

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
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