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RSS FeedPosted by Michael Wonder on 06 Nov 2020
Genmab announces that Janssen has submitted a Type II variation application to the European Medicines Agency for use of subcutaneous Darzalex (daratumumab) in patients with light-chain amyloidosis
5 November 2020 - Submission is based on data from the Phase 3 ANDROMEDA (AMY3001) trial. ...
Posted by Michael Wonder on 05 Nov 2020
EMA will assess potential COVID-19 vaccine on ‘case by case’ basis
5 November 2020 - Agency will not specify a minimum level of efficacy. ...
Posted by Michael Wonder on 05 Nov 2020
Vertex announces European Commission approval for Kalydeco (ivacaftor) as first and only CFTR modulator to treat eligible infants with cystic fibrosis as early as four months of age
5 November 2020 - Approval provides opportunity to treat the underlying cause of cystic fibrosis earlier than ever before in Europe. ...
Posted by Michael Wonder on 05 Nov 2020
Lynparza approved in the EU as first-line maintenance treatment with bevacizumab for HRD positive advanced ovarian cancer
5 November 2020 - Patients treated with Lynparza and bevacizumab lived without disease progression for a median of 37.2 months vs. ...
Posted by Michael Wonder on 05 Nov 2020
Lynparza approved in the EU for the treatment of BRCA mutated metastatic castration-resistant prostate cancer
5 November 2020 - Only PARP inhibitor to improve overall survival versus new hormonal agent treatments in BRCA mutated metastatic ...
Posted by Michael Wonder on 05 Nov 2020
Forxiga approved in the EU for heart failure
5 November 2020 - Forxiga is the first SGLT2 inhibitor approved in the EU for heart failure with reduced ejection ...
Posted by Michael Wonder on 05 Nov 2020
Sobi launch Doptelet (avatrombopag) in Europe
4 November 2020 - Sobi today announced the commercial launch of Doptelet (avatrombopag) in Europe, with the United Kingdom as ...
Posted by Michael Wonder on 03 Nov 2020
GenSight Biologics reports validation of Lumevoq marketing authorisation application by European Medicines Agency
3 November 2020 - GenSight Biologics today reported that the Lumevoq marketing authorisation application passed the validation checks required for submissions ...
Posted by Michael Wonder on 03 Nov 2020
ChemoCentryx and VFMCRP announce European Medicines Agency has accepted to review the marketing authorisation application for avacopan
3 November 2020 - Regulatory submission based on positive data from the pivotal Phase 3 ADVOCATE trial of avacopan. ...
Posted by Michael Wonder on 03 Nov 2020
European Medicines Agency validates marketing application for filgotinib for the treatment of ulcerative colitis
2 November 2020 - Application based on results from pivotal Phase 2b/3 SELECTION trial. ...
Posted by Michael Wonder on 02 Nov 2020
European Commission approves Zejula (niraparib) as first-line monotherapy maintenance treatment in advanced ovarian cancer
29 October 2020 - Zejula is the first PARP inhibitor approved as monotherapy in the European Union for patients with platinum-responsive ...
Posted by Michael Wonder on 02 Nov 2020
GSK Nucala (mepolizumab) filings accepted by European Medicines Agency for three additional eosinophil-driven diseases
29 October 2020 - Submissions based on positive data from pivotal studies in hypereosinophilic syndrome, chronic rhinosinusitis with nasal polyps and ...
Posted by Michael Wonder on 02 Nov 2020
European Commission approves Roche’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
2 November 2020 - Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved in Europe for ...
Posted by Michael Wonder on 02 Nov 2020
DBV Technologies announces filing and validation of marketing authorisation application for Viaskin Peanut by European Medicines Agency
2 November 2020 - DBV Technologies today announced that its marketing authorisation application for its investigational product Viaskin Peanut (DBV712) has ...
Posted by Michael Wonder on 01 Nov 2020
Novartis sickle cell medicine Adakveo approved in Europe to prevent recurrent vaso-occlusive crises
30 October 2020 - Adakveo is the first targeted sickle cell disease therapy for prevention of recurrent vaso-occlusive crises available for ...