FDA and EMA staffers talk monthly on topics related to pediatric uses, resulting in 15 non-binding joint commentaries.
Oncology and gastroenterology products so far are benefiting the most from a relatively new collaboration between the European Medicines Agency and the US FDA to provide informal parallel scientific advice to developers of selected pediatric medicines under review at both agencies.
Under the collaboration, the pediatric "cluster" of EMA and FDA officials holds monthly teleconferences to discuss product-specific or general pediatric...
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
