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RSS FeedPosted by Michael Wonder on 29 Mar 2021
Saxenda recommended for approval by European Medicines Agency committee for the treatment of obesity in adolescents aged 12–17 years
26 March 2021 - Novo Nordisk today announced that the CHMP under the EMA has recommended that the use of Saxenda ...
Posted by Michael Wonder on 29 Mar 2021
GSK receives CHMP positive opinion recommending approval of Benlysta for adult patients with active lupus nephritis
26 March 2021 - GlaxoSmithKline today announced the CHMP of the EMA has adopted a positive opinion recommending the use of ...
Posted by Michael Wonder on 29 Mar 2021
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat people with cystic fibrosis with at least one F508del mutation
26 March 2021 - If approved, people ages 12 years and older who have one copy of the F508del mutation and ...
Posted by Michael Wonder on 28 Mar 2021
Astellas receives positive CHMP opinion for Xtandi (enzalutamide) for patients with metastatic hormone-sensitive prostate cancer
26 March 2021 - If approved by the European Commission, enzalutamide will be the only oral therapy for the treatment of ...
Posted by Michael Wonder on 26 Mar 2021
Highlights from the CHMP 22-25 March 2022 meeting
26 March 2021 - EMA’s CHMP recommended five medicines for approval at its March 2021 meeting. ...
Posted by Michael Wonder on 26 Mar 2021
Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
26 March 2021 - EMA’s CHMP has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines ...
Posted by Michael Wonder on 26 Mar 2021
European Medicines Agency accepts marketing authorisation application for enfortumab vedotin
26 March 2021 - Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial ...
Posted by Michael Wonder on 26 Mar 2021
Europe slams the brakes on vaccine exports until its needs are met
26 March 2021 - Europe has stepped back from its threat to seize AstraZeneca factories or enact a full vaccine ...
Posted by Michael Wonder on 26 Mar 2021
Takeda begins regulatory submissions for dengue vaccine candidate in EU and Dengue-endemic countries
26 March 2021 - EMA to conduct first-ever parallel assessment of a medicinal product, Takeda’s dengue vaccine candidate (TAK-003), for use ...
Posted by Michael Wonder on 26 Mar 2021
Attacks on AstraZeneca cast doubt over its vaccine pricing, says top scientist
26 March 2021 - The EU’s attacks on AstraZeneca call into question the company’s decision not to profit from its ...
Posted by Michael Wonder on 26 Mar 2021
EMA validates marketing authorisation application for sacituzumab govitecan-hziy for the treatment of metastatic triple negative breast cancer
25 March 2021 - Agency grants accelerated assessment based on positive results of Phase 3 ASCENT trial. ...
Posted by Michael Wonder on 25 Mar 2021
Europe’s plans to restrict vaccine exports are dangerous
24 March 2021 - For itself—and for the world. ...
Posted by Michael Wonder on 25 Mar 2021
Statement on COVID-19 vaccine supply at Anagni plant in Italy
24 March 2021 - AstraZeneca would like to clarify a number of inaccurate statements relating to COVID-19 Vaccine AstraZeneca doses ...
Posted by Michael Wonder on 25 Mar 2021
COVID-19 Vaccine AstraZeneca – update on ongoing evaluation of blood clot cases
25 March 2021 - Last week, EMA’s safety committee, PRAC, concluded its preliminary review of cases of blood clots, including very ...
Posted by Michael Wonder on 23 Mar 2021
Increasingly, Europeans do not trust AstraZeneca’s vaccine
22 March 2021 - Hesitancy could put the continent’s exit strategy from the pandemic at risk. ...