The MHRA’s chief executive explains to the Pink Sheet how the agency will ensure the UK remains an attractive place to seek approval of new innovative drugs and build on the regulatory flexibilities introduced during the COVID-19 pandemic.
The UK Medicines and Healthcare products Regulatory Agency has painted a positive picture of its post-Brexit performance, saying that new drug applications have remained at “sustained levels” since the UK left the EU, and that the number of clinical trials is “buoyant.”
The agency also has an “exciting new operating model” that includes a new Innovative Medicines team, while its new international...
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
