Daiichi Sankyo and AstraZeneca's breast cancer drug Enhertu approved in UK (Pharmafile)
'I’m not trying to rebuild an ego': Neil Woodford appeals to professionals for his comeback biotech fund (Endpoints)
Cellectis signs $760M milestone deal with NK upstart; Immunocore brings on AstraZeneca vet to shepherd bispecific launch plans (Endpoints)
Sesen Bio, after years on the edge of irrelevancy, scores speedy review for long gestating bladder cancer program (Endpoints)
GSK starts Phase III RSV candidate vaccine programme for older adults (Press)
Medtech
BD drug-coated balloon faces uphill battle in FDA panel review (MedtechDive)
BD secures EUA, CE Mark for molecular test for both COVID-19 and flu (MassDevice)
Axonics implantable neurostimulator wins FDA PMA supplemental approval (MassDevice)
Government, Regulatory & Legal
Pharmaceutical Patents on Manufacturing Methods: Groundless or Well-Supported? (Harvard Bill of Health)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.