Europe

The European Medicines Agency’s human medicines committee, the CHMP, is this week deciding whether to back marketing approval for eight new drugs and a coronavirus vaccine.

The commission is in talks with EU member states to identify possible regulatory bottlenecks in the approval of combined clinical trials for a medicinal product and a clinical performance study of an IVD.

A report from the EMA summarizing the mid-term achievements of its Regulatory Science Strategy to 2025 covers health technology assessments and a range of other topics.

Plans for the overhaul of the EU’s medicines framework are missing key analysis on the effect of reductions in data and market protection on the pharmaceutical industry, despite an abundance of studies on how such incentives influence company decisions on whether to develop new products, say lawyers from Sidley.

EU regulators have issued a new Q&A document on the key aspects that sponsors of complex trials should consider when making new submissions or moving ongoing studies to the Clinical Trials Information System.

Two members of the European Parliament claim the latest delay to publication of the long-awaited legislative revision is the result of pressure from the pharmaceutical industry.

The single-dose gene therapy for aromatic L-amino acid decarboxylase in children is to be made available on the National Health Service following a confidential commercial deal between NHS England and PTC Therapeutics.

The UK has finalized plans for delivering what it believes will be a stable and streamlined clinical trials framework following its departure from the EU. Transparency, patient involvement and diversity are high on the agenda.

The UK pharma industry body has set out bold proposals for a new drug pricing agreement from 2024, but not everyone is convinced. Generics companies are pressing for more of a say in the negotiations, while patient groups want to know more about how the deal would help improve access to medicines.

Eurordis has welcomed some parts of the leaked proposals for overhauling the EU medicines legislation, but it has a number of concerns, including the future role of patient representatives if the European Medicines Agency’s committee structure is slimmed down as planned.

Health technology assessment institute NICE has reversed its provisional rejection of Oxlumo for treating the rare disease, primary hyperoxaluria type 1.

Sugemalimab, from CStone Pharmaceuticals/EQRx, for use in combination with chemotherapy as first-line treatment for metastatic non-small cell lung cancer, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.