The sponsors of six drugs that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.
Roche, Takeda and Agios Pharmaceuticals are among the sponsors that may this week present before the European Medicines Agency to explain why their respective drugs – faricimab, mobocertinib and mitapivat – should be approved for marketing across the EU.
Faricimab, mobocertinib and mitapivat are among six drugs for which their sponsors are listed as being due, or possibly due, to speak at oral explanation meetings, according to the
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.
At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.
