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RSS FeedPosted by Michael Wonder on 12 Oct 2021
EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac
13 October 2021 - The EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company ...
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 05 Oct 2021
Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
4 October 2021 - EMA’s CHMP has concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax ...
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 27 Sep 2021
EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
27 September 2021 - EMA has started evaluating an application for the use of a booster dose of Spikevax (Moderna’s ...
Posted by Michael Wonder on 16 Sep 2021
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis
16 September 2021 - AbbVie today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg ...
Posted by Michael Wonder on 14 Sep 2021
Alnylam submits marketing authorisation application to the European Medicines Agency for investigational vutrisiran for the treatment of hereditary ATTR amyloidosis with polyneuropathy
13 September 2021 - If approved, vutrisiran will provide a new, subcutaneously administered, once quarterly treatment option for patients with hATTR ...
Posted by Michael Wonder on 14 Sep 2021
Mirum Pharmaceuticals submits European marketing authorisation application for maralixibat in Alagille syndrome supported by new positive results from natural history study comparison
13 September 2021 - Natural history analysis shows significant improvement in event-free survival and transplant-free survival. ...
Posted by Michael Wonder on 06 Sep 2021
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty
6 September 2021 - EMA has started evaluating an application for the use of a booster dose of Comirnaty to be ...
Posted by Michael Wonder on 05 Sep 2021
Moderna announces submission of data to European Medicines Agency for its COVID-19 vaccine booster
3 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against ...
Posted by Michael Wonder on 27 Aug 2021
Argenx announces validation of European marketing authorisation application for efgartigimod in generalised myasthenia gravis
25 August 2021 - Validation initiates formal evaluation of application which started on 19 August 2021; decision expected mid-2022. ...