Drug Safety

The biotech plans a pivotal trial that would support accelerated approval of the Takeda-partnered antisense oligonucleotide, WVE-003, and will discuss it with regulators before the end of the year.

Not enough companies are complying with Pakistan’s pharmacovigilance rules, according to the drug regulator, which wants to remedy the situation after a previous attempt to do so failed.

Globally harmonized guidance on evaluating the viral safety of biotechnology products has undergone major revisions for the first time in over two decades to address a raft of scientific advances. Manjula Aysola explores the changes and their impact for manufacturers.

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.

FDA leadership weighs in on limitations of AI as part of rollout of new technology meeting program that looks to give industry and other stakeholders a chance to inform future regulation.

A targeted review of the rules on labeling for injectable medicines is being carried out in advance of a wider updating of labeling requirements that took effect in 2020.

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits.

New guidance from the International Council for Harmonisation is designed to tackle problems companies face by having to meet different requirements around the world when evaluating the potential of DDIs for their investigational products.

With more than 16% of hospital admissions in the UK caused by adverse drug reactions, costing the country upwards of £2bn a year, a genomics expert explains how pharmacogenomic tests could benefit both patients and the health care system.

An internationally harmonized framework for generating adequate evidence using fit-for-purpose real-world data to address regulatory questions on the safety of medicines is out for public consultation.

‘Short-term effects of midomafetamine were not captured’ in the clinical program for post-traumatic stress disorder, FDA notes. Proposed REMS for the psychedelic therapy to be discussed at 4 June would limit dispensing setting, restrict post-treatment driving.

Advances in cell and gene therapy, together with the forthcoming EU joint clinical assessments, have raised questions about the ethics of having to use randomized controlled trials to test new advanced therapies.

17-OHPC medicines are to be pulled from the market in Europe due to a potential link with cancer and the lack of efficacy data. The move comes around a year after the US regulator withdrew its approval of a similar drug from Covis.

A keenly-awaited legislative amendment that is expected to be adopted by the end of this year would introduce more proportionate requirements for drug sponsors to monitor the EudraVigilance database.

Compliance functions will be moved to the product centers when ORA becomes the Office of Inspections and Investigations, and centers will become responsible for making the final agency decision on inspection classifications, Associate Commissioner Michael Rogers said.

The European Parliament has voted for a deal agreed with the council of ministers to ensure polluters pay for cleaning up urban wastewater.