Blog
RSS FeedPosted by Michael Wonder on 13 Oct 2021
EU may consider deal on Merck's COVID pill after approval procedure begins
12 October 2021 - The European Union may consider signing a supply deal with U.S. drugmaker Merck for its experimental ...
Posted by Michael Wonder on 12 Oct 2021
EMA publishes agenda for 11-14 October CHMP meeting
11 October 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 11 Oct 2021
EMA receives application for marketing authorisation for Ronapreve (casirivimab with imdevimab) for treatment and prevention of COVID-19
11 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve (casirivimab ...
Posted by Michael Wonder on 06 Oct 2021
EMA to consider rolling review for Merck's molnupiravir in coming days
5 October 2021 - The EMA will consider in the coming days whether to launch a rolling review of Merck's ...
Posted by Michael Wonder on 05 Oct 2021
EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
4 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Regkirona (regdanvimab, also known ...
Posted by Michael Wonder on 02 Oct 2021
European Medicines Agency validates Bristol Myers Squibb’s application for LAG-3 blocking antibody relatlimab and nivolumab fixed dose combination as first-line treatment for patients with unresectable or metastatic melanoma
1 October 2021 - The Phase 2/3 RELATIVITY-047 trial served as the basis for this application, in which a statistically ...
Posted by Michael Wonder on 02 Oct 2021
European Medicines Agency validates Bristol Myers Squibb’s application for mavacamten for the treatment of obstructive hypertrophic cardiomyopathy
1 October 2021 - Application based on positive results from Phase 3 EXPLORER-HCM trial. ...
Posted by Michael Wonder on 01 Oct 2021
Xbrane Biopharma announces that partner Stada's marketing authorisation application for ranibizumab is submitted and validated by European Medicines Agency
30 September 2021 - Xbrane Biopharma today announces that a marketing authorisation Application for biosimilar ranibizumab submitted by its co-development ...
Posted by Michael Wonder on 30 Sep 2021
Acacia Pharma announces submission and validation of marketing authorisation application for Barhemsys (amisulpride injection) in major European markets
29 September 2021 - Acacia Pharma announces that its marketing authorisation application for Barhemsys (amisulpride injection) has been submitted, validated and ...
Posted by Michael Wonder on 29 Sep 2021
EMA implements new measures to minimise animal testing during medicines development
29 September 2021 - EMA is putting in place special support to developers to replace, reduce and refine animal use for ...
Posted by Michael Wonder on 21 Sep 2021
Lilly announces procurement agreement with European Commission to supply bamlanivimab and etesevimab together for the treatment of confirmed COVID-19
21 September 2021 - Joint Procurement Agreement enables European countries to purchase bamlanivimab and etesevimab directly from Lilly, in varying ...
Posted by Michael Wonder on 20 Sep 2021
EU panel rejects Pfizer’s tanezumab for osteoarthritis pain
19 September 2021 - Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor ...
Posted by Michael Wonder on 19 Sep 2021
Highlights from the CHMP 13-16 September 2021 meeting
17 September 2021 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2021 meeting. ...
Posted by Michael Wonder on 19 Sep 2021
GSK receives CHMP positive opinions recommending approval of Nucala (mepolizumab) in three additional eosinophil driven diseases
17 September 2021 - If approved in Europe, mepolizumab would be the only treatment indicated for use in four eosinophil-driven diseases. ...
Posted by Michael Wonder on 19 Sep 2021
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)
17 September 2021 - Recommendation based on data from Phase 3 KEYNOTE-355 trial. ...