European regulators begin rolling review of AZ’s COVID-19 vaccineEuropean regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca Share XEuropean regulators begin rolling review of AZ’s COVID-19 vaccinehttps://pharmaphorum.com/news/european-regulators-begin-rolling-review-of-azs-covid-19-vaccine/
FDA launches Digital Health Center of ExcellenceThe FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment Share XFDA launches Digital Health Center of Excellencehttps://pharmaphorum.com/news/fda-launches-digital-health-center-of-excellence/
Trump’s vaccine ‘October surprise’ in doubt as FDA toughens standardsThe FDA is expected to lay out tougher standards for any emergency authorisation of a COVID-19 vaccine, to Share XTrump’s vaccine ‘October surprise’ in doubt as FDA toughens standardshttps://pharmaphorum.com/news/fda-to-lay-out-tougher-covid-19-vaccine-standards/
EU regulators begin fast review of dexamethasone for COVID-19European regulators have begun a speedy review of dexamethasone as a treatment for adults hospitalised with COVID-19, a Share XEU regulators begin fast review of dexamethasone for COVID-19https://pharmaphorum.com/news/eu-regulators-begin-review-of-dexamethasone-for-covid-19/
MHRA publishes guidance on medicine regulation after BrexitThe UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK Share XMHRA publishes guidance on medicine regulation after Brexithttps://pharmaphorum.com/news/mhra-publishes-guidance-on-medicine-regulation-after-brexit/
Exclusive interview with ForwardVue Pharma released for Ophthalmic Drugs 2020Exclusive interview with ForwardVue Pharma Share XExclusive interview with ForwardVue Pharma released for Ophthalmic Drugs 2020https://pharmaphorum.com/partner-content/exclusive-interview-with-forwardvue-pharma-released-for-ophthalmic-drugs-2020/
BioMarin files achondroplasia drug after rejection for haemophilia therapyUS biotech BioMarin has hit back with a filing for a rare disease drug, after suffering what was Share XBioMarin files achondroplasia drug after rejection for haemophilia therapyhttps://pharmaphorum.com/news/biomarin-files-achondroplasia-drug-after-rejection-for-haemophilia-therapy/
NS Pharma takes on Sarepta as FDA approves DMD drugThe FDA has approved a new therapy for the rare muscle wasting disease Duchenne muscular dystrophy (DMD) as Share XNS Pharma takes on Sarepta as FDA approves DMD drughttps://pharmaphorum.com/news/ns-pharma-sarepta-fda-approves-dmd-drug/
UK patients get early access to Alnylam’s ultra-rare disease drug lumasiranThe UK’s regulator has granted early access to Alnylam’s ultra-rare disease drug lumasiran, allowing patients with primary hyperoxaluria Share XUK patients get early access to Alnylam’s ultra-rare disease drug lumasiranhttps://pharmaphorum.com/news/uk-patients-get-early-access-to-alnylams-ultra-rare-disease-drug-lumasiran/