Eiger attributes the change in status of the EU marketing authorization application for lonafarnib to the need for an inspection and the ongoing coronavirus pandemic.
Lonafarnib, Eiger BioPharmaceuticals’ investigational treatment for progeria and progeroid laminopathies, has lost its accelerated assessment status at the European Medicines Agency. The EU marketing authorization application (MAA) for the oral farnesyltransferase inhibitor will now be reviewed under standard timelines.
The US company attributed the change in review status to the EMA's desire to carry out an inspection and to...
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Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022.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Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022.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.
