Europe

The EMA says the benefits of treatment with Leqembi are not large enough to outweigh its risks. Meanwhile, Alzheimer Europe is hoping that real-world findings from the US-mandated patient registry or from ongoing trials will help persuade the EU regulator to reconsider its position.

Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for pan-EU approval.

The implementation phase of the European Health Data Space is an opportunity to address “critical aspects” of the new regulation that require clarification, says pharmaceutical industry federation EFPIA.

The number of medicines containing a new active substance approved for pan-EU marketing in the first six months of 2024 rose to near-normal levels after an unusually sharp dip in the 2023 period. The approvals were again led by cancer drugs, with therapies for blood disorders a close second, while half of the approvals were treatments for rare diseases.

The UK’s drug regulator said that a trial run by cell therapy firm Celixir “risked seriously jeopardizing the rights, safety and wellbeing of trial participants” after an inspection discovered expired product batches, unauthorized dosing and other serious breaches.

EU member states have agreed to routinely use a flexible process that can facilitate the use of multilingual packaging for prescription-only medicines.

Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores how the two agencies applied the available regulatory flexibilities and the impact of other factors, such as regulatory precedence and patient influence, on decision-making.

Targeting the JN.1 subvariant of the SARS-CoV-2 virus will facilitate timely vaccination campaigns in Europe to help reduce the burden of disease associated with COVID-19, according to the EU regulator.

The European Medicines Agency has issued draft recommendations on how vaccine developers can generate efficacy data to enable their product’s safe use in immunocompromised individuals.

In this final article in a series on the ongoing amendments to the pharmaceutical reform package, the Pink Sheet looks at the tougher environmental risk assessment requirements that pharma companies are likely to face in the not-too-distant future.

The draft guidance addresses specific requirements for oligonucleotide-based medicines that are not answered in existing guidance documents, and has been two years in the making.

EU regulators say they have tackled many of the concerns raised by study sponsors in two surveys regarding the implementation of the EU Clinical Trials Regulation and are now focused on addressing the five “most critical remaining challenges.”

Eisai/Biogen could this week learn whether the European Medicines Agency will give the thumbs up to market lecanemab across the EU for early Alzheimer’s disease.

A number of legislative proposals will be coming under scrutiny at the newly constituted European Parliament in the coming months, including the pharma reform package and draft legislation on EU-level compulsory licensing and “unitary” supplementary protection certificates.

Evidence generated through an EU public-private funding initiative has resulted in a new biomarker method for measuring the level of Alzheimer’s disease in a person’s brain, which drug developers can use during clinical trials.

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies and secure the supply of generics and biosimilars.