Kite cues up first EMA okay for mantle cell lymphoma CAR-TGilead Sciences’ Kite Pharma unit is closing on approval of its second European approval for a CAR-T for Share XKite cues up first EMA okay for mantle cell lymphoma CAR-Thttps://pharmaphorum.com/news/kite-cues-up-first-ema-okay-for-mantle-cell-lymphoma-car-t/
Novartis’ big bet on inclisiran nears fruition, as CHMP backs drugNovartis’ near-$10 billion takeover of The Medicines Company last year was focused mainly on one asset – cholesterol-lowering Share XNovartis’ big bet on inclisiran nears fruition, as CHMP backs drughttps://pharmaphorum.com/news/novartis-big-bet-on-inclisiran-nears-fruition-as-chmp-backs-drug/
Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jabThe European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by Share XRace for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jabhttps://pharmaphorum.com/news/ema-begins-rolling-review-biontech-pfizers-covid-19-shot/
EMA starts rapid review of Bluebird’s gene therapy for rare disease CALDBluebird bio could be just a few months away from approval of its gene therapy for rare disease Share XEMA starts rapid review of Bluebird’s gene therapy for rare disease CALDhttps://pharmaphorum.com/news/ema-starts-rapid-review-of-bluebirds-gene-therapy-for-rare-disease-cald/
EMA review of AZ’s COVID-19 vaccine imminent; reportThe EU regulator is poised to start a review of AstraZeneca and Oxford University’s COVID-19 vaccine, but the Share XEMA review of AZ’s COVID-19 vaccine imminent; reporthttps://pharmaphorum.com/news/ema-review-of-azs-covid-19-vaccine-imminent-report/
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/
Sanofi faces possible manslaughter charges in epilepsy drug probeSanofi has been placed under formal investigation in France for possible charges including manslaughter relating to the epilepsy Share XSanofi faces possible manslaughter charges in epilepsy drug probehttps://pharmaphorum.com/news/sanofi-faces-possible-manslaughter-charges-in-epilepsy-drug-probe/
COVID-19 drug remdesivir recommended for EU approvalThe EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Gilead’s COVID-19 treatment remdesivir Share XCOVID-19 drug remdesivir recommended for EU approvalhttps://pharmaphorum.com/news/covid-19-drug-remdesivir-recommended-for-eu-approval/
Gilead files remdesivir for EU approval, with a verdict possible “in weeks”The EMA has said it will fast-track the review of Gilead Sciences’ remdesivir as a treatment for COVID-19, Share XGilead files remdesivir for EU approval, with a verdict possible “in weeks”https://pharmaphorum.com/news/gilead-files-remdesivir-for-eu-approval-with-a-verdict-possible-in-weeks/
