Blog
RSS FeedPosted by Michael Wonder on 01 Feb 2021
Incyte announces positive CHMP opinion for pemigatinib for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement
29 January 2021 - If approved, pemigatinib will be the first targeted therapy indicated in the EU for this indication. ...
Posted by Michael Wonder on 01 Feb 2021
EMA starts rolling review of REGN-COV2 antibody combination (casirivimab/imdevimab)
1 February 2021 - EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a medicine known ...
Posted 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 29 Jan 2021
EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU
29 January 2021 - COVID-19 Vaccine AstraZeneca is now authorised across the EU. This follows the granting of a conditional marketing ...
Posted by Michael Wonder on 29 Jan 2021
First COVID-19 vaccine safety update published
29 January 2021 - Today EMA has released its first safety update on a COVID-19 vaccine — Comirnaty. ...
Posted by Michael Wonder on 28 Jan 2021
Germany moves to exclude seniors from AstraZeneca’s COVID-19 vaccine
28 January 2021 - Ahead of its expected approval for use by Europe’s medicines regulator Friday, Germany’s vaccine committee has recommended ...
Posted by Michael Wonder on 28 Jan 2021
Clarification of Comirnaty dosage interval
28 January 2021 - EMA’s human medicines committee (CHMP) has updated the product information for the COVID-19 vaccine Comirnaty to ...
Posted by Michael Wonder on 27 Jan 2021
E.U. and U.K. fighting over scarce vaccines
27 January 2021 - As vaccine production falls behind schedule, and the European Union lags in inoculating people, Brussels and London ...
Posted by Michael Wonder on 27 Jan 2021
EU demands UK made AstraZeneca vaccine doses
27 January 2021 - The EU has urged pharmaceutical firm AstraZeneca to supply it with more doses of its COVID-19 ...
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
AstraZeneca is finding it hard to keep its COVID-19 vaccine promises
26 January 2021 - As countries scramble to inoculate their populations against COVID-19, the vaccine developed by AstraZeneca and the ...
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 ...