Blog
RSS FeedPosted by Michael Wonder on 31 Jan 2021
Amarin receives positive CHMP opinion for icosapent ethyl for cardiovascular risk reduction
29 January 2021 - Positive opinion is based on extensive clinical study results, including results of the REDUCE-IT cardiovascular outcomes trial. ...
Posted by Michael Wonder on 29 Jan 2021
Novartis receives positive CHMP opinion for Kesimpta (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis
29 January 2021 - CHMP opinion is based on two Phase 3 ASCLEPIOS trials that met the primary outcomes where Kesimpta ...
Posted by Michael Wonder on 29 Jan 2021
Highlights from 25-29 January 2021 CHMP meeting
29 January 2021 - EMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its January 2021 meeting. ...
Posted by Michael Wonder on 27 Jan 2021
European Medicines Agency accepts GBT’s marketing authorisation application for Oxbryta (voxelotor) for the treatment of haemolytic anemia in sickle cell disease
27 January 2021 - Global Blood Therapeutics today announced that the EMA has completed the validation of GBT’s marketing authorisation application ...
Posted by Michael Wonder on 27 Jan 2021
European Commission approves Keytruda (pembrolizumab) as first-line treatment in adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
26 January 2021 - Keytruda is first checkpoint inhibitor approved in Europe to treat MSI-H or dMMR colorectal cancer. ...
Posted by Michael Wonder on 25 Jan 2021
European Commission approves AbbVie's Rinvoq (upadacitinib) for the treatment of psoriatic arthritis and ankylosing spondylitis
25 January 2021 - Approval is supported by data from three pivotal clinical studies in psoriatic arthritis and ankylosing spondylitis where ...
Posted by Michael Wonder on 25 Jan 2021
EMA publishes agenda for 25-29 January CHMP meeting
25 January 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 25 Jan 2021
European Commission approves Bavencio (avelumab) for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
25 January 2021 - BAVENCIO maintenance treatment significantly extended median overall survival versus standard of care in the Phase 3 JAVELIN ...
Posted by Michael Wonder on 22 Jan 2021
Menarini receives European Commission approval of Elzonris (tagraxofusp), for the treatment of blastic plasmacytoid dendritic cell neoplasm
21 January 2021 - Elzonris is the first approved treatment for patients with blastic plasmacytoid dendritic cell neoplasm, and the ...
Posted by Michael Wonder on 21 Jan 2021
Human medicines: highlights of 2020
21 January 2021 - EMA has published an PDF iconoverview of its key recommendations in 2020 on the authorisation and ...
Posted by Michael Wonder on 21 Jan 2021
Doptelet (avatrombopag) approved in the EU for treatment of ITP
20 January 2021 - Sobi today announced that the European Commission has approved an extension of the indication for Doptelet ...
Posted by Michael Wonder on 20 Jan 2021
Enhertu approved in the EU for the treatment of HER2 positive metastatic breast cancer
20 January 2021 - Approval based on the DESTINY-Breast01 Phase 2 trial which showed clinically meaningful and durable responses in patients ...
Posted by Michael Wonder on 19 Jan 2021
Tessa Therapeutics receives PRIME designation from European Medicines Agency for CD30 CAR-T therapy
18 January 2021 - Tessa Therapeutics today announced that the EMA has granted PRiority MEdicines (PRIME) designation to the company's lead ...
Posted by Michael Wonder on 15 Jan 2021
Imfinzi approved in the EU for less frequent, fixed dose use in unresectable non-small cell lung cancer
15 January 2021 - New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 14 Jan 2021
ViiV Healthcare receives EU marketing authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe
13 January 2021 - Dolutegravir is the first integrase inhibitor available as a dispersible tablet for children weighing at least 3kg ...