Europe

The European Medicines Agency believes Idorsia’s Jeraygo should be approved for use in the EU at two different doses rather than just the one approved by the US Food and Drug Administration last month.

The European Commission’s landmark AI Act will introduce strict new rules for AI systems, with the exception of products used solely for scientific research, something that could be good news for pharma, according to industry body EFPIA.

The European Health Data Space is expected to give researchers, industry and public bodies access to large amounts of high-quality health data for the development of new treatments and vaccines. The European Parliament has also approved new rules on Substances of Human Origin.

About 10% of marketed medicines chosen at random in Denmark had “non-functioning” anti-tamper devices, leaving them open to possible interference.

Real-world evidence and patient involvement can help developers shore up evidence from single arm trials for EU-wide joint clinical assessments.

A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules. 

In the first of a series of articles on the future direction of the EU pharmaceutical reform proposals, the Pink Sheet looks at the new uncertainties created for the drug industry after the European Parliament voted through a series of amendments in the area of regulatory data protection.

Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

The UK is not alone in experiencing drug shortages, as data from across Europe show, but its departure from the EU makes it more difficult to respond to supply chain pressures, according to new research.

The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.

Great Ormond Street Hospital is piloting a new approach to gene therapy delivery in which it will submit a marketing authorization application to the UK regulator for a lentiviral gene therapy used to treat ADA-SCID, a rare disease.

Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.

Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.

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.

Sponsors need guidance on ethics requirements and clarity around national regulations to conduct cross-border clinical trials in the EU, a multi-stakeholder forum says.

Roche’s lymphoma drug Polivy could face pricing challenges in Germany as it undergoes a full benefit assessment.