Citeline, a Norstella company

Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.

The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Sandoz snatched commercialization rights to Lupin’s ranibizumab biosimilar across multiple global markets, while also taking steps to decarbonize its operations in Europe.

The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.

Scrip spoke with executives at artificial intelligence biotech firms and a big pharma company during the recent BIO conference about using AI in ways that add real value to drug development.

Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.