Teclistamab and nirsevimab may or not be fast-tracked when their sponsors – Janssen-Cilag and Sanofi, respectively – file for pan-EU approval. In the meantime, a total of seven filings are currently benefiting from the accelerated assessment mechanism at the European Medicines Agency.
Janssen-Cilag and Sanofi have seemingly yet to disclose whether the investigational monoclonal antibodies they are developing – teclistamab and nirsevimab, respectively – will be fast-tracked at the European Medicines Agency when the companies file for approval.
Teclistamab is in development for the treatment of heavily pre-treated adult patients with relapsed or refractory multiple myeloma. Nirsevimab is...
After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.
Insurance trade groups warned that the Big Beautiful Bill destabilize Medicaid and result in the largest ever roll-back in health care coverage in the US.
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.
A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
