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Europe

Set Alert for Europe

Health System Reform Crucial For ATMPs

The difficulties in getting advanced therapies, such as Novartis’ CAR T therapy Kymriah, to patients have shifted and manufacturing capacity is no longer the biggest issue.

Europe Gene Therapy

Advanced Therapy Developers Urged To Monitor Major EU Proposal On Using Blood, Tissues & Cells

Companies have the opportunity to tell the European Commission what they think about its proposed regulation that would overhaul the rules governing the use of substances of human origin.

Europe Gene Therapy

Global Pharma Guidance Tracker – July 2022

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

Accelerated Assessment Dry Spell Over As EMA Says Yes To Pharming’s Leniolisib

Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.

Review Pathway Immune Disorders

Not A Smooth Ride: How One Of The First Studies Navigated The EU Clinical Trial Portal

 From grappling with a never-ending list of conflicting national requirements to dealing with numerous technical issues, a research project manager at Norway’s Oslo University Hospital talks about the hiccups faced by their multinational COVID-19 platform trial that was among the first studies submitted for approval under the EU Clinical Trial Regulation.

Clinical Trials Regulation

Rhythm Wins Reimbursement For Obesity Drug Imcivree In France & England

France is set to become the first country in Europe to fund Imcivree for a second – and as yet unapproved – indication. Meanwhile, England has agreed to reimburse the drug for its approved indication as did Germany earlier this year. Reimbursement discussions are underway in the rest of Europe.

Reimbursement Metabolic Disorders

EU Industry Finds Glaring Gaps In Health Data Access Proposal

Protection of IP and trade secrets and the need for clarity around issues such as the rules on access to data and the sharing of clinical trial data are seen as key issues in the European Commission’s plans for a European Health Data Space.

Europe Legal Issues

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Upstaza, PTC Therapeutics’ disease-modifying gene therapy for children with the fatal, rare genetic disorder, AADC deficiency.

Europe Approvals

RWE Studies To Hit 100+ Per Year In Europe By 2025

The EU’s big data steering group has laid out some ambitious proposals for integrating real-world evidence into regulatory decision making, as well as plans for ongoing engagement on the use and analysis of RWE with industry and other stakeholders.

Europe Real-World Evidence

Accelerated Assessment Requests Fall Flat At EMA

Very few companies asked the European Medicines Agency to fast track their drug marketing authorization applications in the first half of this year, and those that did were all turned down.

Review Pathway Europe

UK CMA Issues £70m Fines To Pfizer And Flynn Over Phenytoin

After reassessing part of a UK case involving Pfizer and Flynn Pharma over pricing for phenytoin sodium capsules, the country’s competition regulator has reaffirmed that the companies abused their dominant positions to overcharge the NHS and has issued £70m in fines.

Legal Issues Pricing Strategies

Access To Innovation Looking Brighter In France

French Biotech In Focus: The French biotech industry body France Biotech says that the authorities are making good progress in reducing the time taken to get new medicines on the market, but that low drug prices and high industry taxes remain key challenges for the industry.

Innovation Market Access
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