Sobi gets EU nod for Doptelet in rare blood disorder ITPSweden’s Sobi has secured EU approval for Doptelet in primary chronic immune thrombocytopenia (ITP), an indication that the Share XSobi gets EU nod for Doptelet in rare blood disorder ITPhttps://pharmaphorum.com/news/sobi-gets-eu-nod-for-doptelet-in-rare-blood-disorder-itp/
EMA says AstraZeneca’s COVID-19 shot could be approved on 29 JanuaryThe European medicines Agency (EMA) said this morning it has received a marketing application from AstraZeneca for its Share XEMA says AstraZeneca’s COVID-19 shot could be approved on 29 Januaryhttps://pharmaphorum.com/news/ema-says-astrazenecas-covid-19-shot-could-be-approved-on-29-january/
EMA will use Panalgo software for real-world data analyticsSix months after rebranding from BHE, Panalgo has won a contract to supply the European Medicines Agency (EMA) Share XEMA will use Panalgo software for real-world data analyticshttps://pharmaphorum.com/news/ema-will-use-panalgo-software-for-real-world-data-analytics/
Daiichi Sankyo, AZ close on EU approval of Enhertu for breast cancerDaiichi Sankyo and AstraZeneca could be just weeks away from an EU approval for their antibody-drug conjugate (ADC) Share XDaiichi Sankyo, AZ close on EU approval of Enhertu for breast cancerhttps://pharmaphorum.com/news/daiichi-sankyo-az-close-on-eu-approval-of-enhertu-for-breast-cancer/
Cyberattack targets EMA, hacks COVID-19 vaccine dataThe European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s Share XCyberattack targets EMA, hacks COVID-19 vaccine datahttps://pharmaphorum.com/news/cyberattack-targets-ema-hacks-covid-19-vaccine-data/
Vertex gets EU okay to treat younger cystic fibrosis patientsA new EMA approval has expanded the use of Vertex Pharma’s exon-skipping cystic fibrosis therapy Symkevi to children Share XVertex gets EU okay to treat younger cystic fibrosis patientshttps://pharmaphorum.com/news/vertex-gets-eu-okay-to-treat-younger-cystic-fibrosis-patients/
Guido Rasi steps down, handing the running of EMA to Emer CookeEMA executive director Guido Rasi has ended his second term at the helm of the EU medicines regulator, Share XGuido Rasi steps down, handing the running of EMA to Emer Cookehttps://pharmaphorum.com/news/guido-rasi-steps-down-handing-the-running-of-ema-to-emer-cooke/
Trials and tribulations in Biogen’s Alzheimer’s drug reviewsRegulatory reviews of Biogen’s Alzheimer’s drug aducanumab are now ongoing on both sides of the Atlantic, but debate Share XTrials and tribulations in Biogen’s Alzheimer’s drug reviewshttps://pharmaphorum.com/news/trials-and-tribulations-in-biogens-alzheimers-drug-reviews/
FDA sets April verdict for Pfizer’s “underestimated” atopic dermatitis drugPfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in Share XFDA sets April verdict for Pfizer’s “underestimated” atopic dermatitis drughttps://pharmaphorum.com/news/fda-sets-april-verdict-for-pfizers-underestimated-atopic-dermatitis-drug/
