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Set Alert for Europe

‘We Tried It, It Does Not Work’ – The Problems With The EU’s SPC Manufacturing Waiver

While the European supplementary protection certificate manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.

Europe Legislation

Anti-Globalism Policy Cannot Stifle International Cooperation, US FDA’s Califf Says

The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.

DIA Supply Chain

EU Pharma Reform Talks Heat Up As Health Ministers Prepare To Challenge Proposals

In a sign of difficult negotiations to come on the European Commission’s pharma reform package, the presidency of the Council of the EU has drawn up its own set of proposals on regulatory data protection and market exclusivity that differ in several respects from those of the commission and the European Parliament.

Europe EU Legislative Reform

NICE Backs Vertex’s CF Drugs Kaftrio, Symkevi & Orkambi After Initial Rejection

Cystic fibrosis patients in England will be able to access Vertex’s three combination therapies after the company announced an extended reimbursement agreement with the National Health Service and a positive opinion from the country’s HTA body, NICE.

BioPharmaceutical Reimbursement

EMA Explains How To Draw Up Shortage Prevention & Mitigation Plans

The shortage prevention plan (SPP) should be part of companies’ pharmaceutical quality system and will be open to inspection, while shortage mitigation plans (SMPs) should be proportionate to the level of risk for each medicine in line with ICH guideline Q9, the EMA says.

Europe Supply Chain

New EU Filings

Sepiapterin, PTC Therapeutics' treatment for hyperphenylalaninemia in adult and pediatric patients with phenylketonuria, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Drug Review Europe

Revised EU Trial Transparency Rules Go Live With Last Minute Changes To Address Confidentiality Concerns

The European Medicines Agency has met the deadline for launching a new version of the Clinical Trials Information System to allow earlier public access to information on authorized studies. However, new concerns raised by commercial sponsors means the publication of certain information fields in CTIS is temporarily suspended.

Europe Clinical Trials

Global Governments ‘Neglecting’ Vaccine Investment Post-COVID

Seth Berkley, epidemiologist and former CEO of Gavi, the vaccine alliance, has emphasized the importance of making “investments in peacetime” to prepare for pandemic threats and called for a “mindset change” among global governments.

United Kingdom BioPharmaceutical

UK Early Access Scheme 'A Success,' But Industry Wants Improvements

Launched in April 2014, the UK’s Early Access to Medicines Scheme has delivered pre-approval patient access to many treatments for life-threatening and seriously debilitating conditions. But after 10 years of the EAMS, the pharmaceutical industry wants new guidance and says the scheme should evolve so that companies can make the most of the opportunity it offers in the future.

Europe United Kingdom

Old Painkiller, Old Concern: EMA Revisits Metamizole’s Safety

The European Medicines Agency is reviewing the known risk of agranulocytosis in people taking medicines containing the painkiller metamizole, which is approved for use in most of the EU member states but banned in the US, the UK and other countries around the world.

Europe Drug Safety

EMA & Health Canada Harmonize Anonymization Reporting For Clinical Trial Reports

Companies submitting clinical data for publication under the European Medicines Agency's Clinical Data Publication policy and Health Canada's Public Release of Clinical Information initiative can now provide a single anonymization report to both regulators. This report would explain the steps taken by sponsors to ensure the anonymized data poses a low risk of re-identification.

Europe Canada

First Drug Treatment For Myopia Among 14 New EU Filings

Vyluma’s eyedrop for treating myopia in children and Vertex’s next-generation triple combination treatment for cystic fibrosis are among the latest drugs that the European Medicines Agency has begun reviewing for potential EU marketing approval.

Europe Drug Review

EU HTA Regulation: Guidance Released On Joint Clinical Assessment Scoping & Reporting

The European Commission’s Member State Coordination Group on HTA has released two new guidance documents aimed at helping member states and assessors to navigate joint clinical assessments under the Health Technology Assessment Regulation.

BioPharmaceutical Europe

Preparing For The Next Pandemic: Experts Talk AI Vaccines, Regulatory Acceptance & Earlier Human Trials

AI-generated vaccines, fast-moving regulatory systems and scalable manufacturing platforms will be key in preparing for future pandemics, according to vaccine and immunology experts including the CEOs of CEPI and Gavi.

BioPharmaceutical International

UK Early Access Scheme Treatments More Likely To Get Faster NICE Stamp Of Approval

The UK’s Early Access to Medicines Scheme celebrated its tenth birthday in April. In the first of two articles on experience with the scheme, the Pink Sheet looks at how far the inclusion of a product on the EAMS affects its chances of securing a positive HTA recommendation from NICE.

Europe United Kingdom

Ireland Should Look To UK & Denmark To Raise Its Clinical Trial Aspirations

Simple, tangible steps taken by the UK and Danish governments to systematically improve their clinical trial environment offer rich learnings for Ireland, which is facing a steady decline in industry-sponsored studies.

Ireland Clinical Trials
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