Just a day before it became mandatory to use the single-portal Clinical Trial Information System, the European Commission published concise advice for sponsors and investigators who want to conduct trials in Europe.
With the EU’s single-portal Clinical Trial Information System (CTIS) becoming mandatory from 31 January for sponsors seeking trial approval, the European Commission has issued a “quick guide” to help companies and investigators understand how to implement the Clinical Trials Regulation (CTR).
The 27-page guide was published on 30 January, the day before the CTR hit the major milestone of the...
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Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022.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Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022.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.
