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RSS FeedPosted by Michael Wonder on 26 Nov 2020
Bio-Thera Solutions submits marketing authorisation application for BAT1706, a proposed biosimilar to Avastin, to European Medicines Agency
25 November 2020 - Bio-Thera Solutions today announced that it has submitted the marketing authorisation application for BAT1706, a proposed biosimilar ...
Posted by Michael Wonder on 24 Nov 2020
ObsEva submits marketing authorisation application to the European Medicines Agency for Yselty (linzagolix) for the treatment of women with uterine fibroids
24 November 2020 - If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen options for the management ...
Posted by Michael Wonder on 24 Nov 2020
Merck submits applications for licensure of V114, the company’s investigational 15 valent pneumococcal conjugate vaccine, for use in adults to the US FDA and EMA
23 November 2020 - Merck today announced the company has submitted applications to the US FDA and EMA for licensure of ...
Posted by Michael Wonder on 24 Nov 2020
VBI Vaccines announces submission of marketing authorisation application for 3 antigen prophylactic hepatitis B vaccine to the European Medicines Agency
23 November 2020 -VBI Vaccines today announced the submission of a marketing authorisation application to the EMA for the Company’s ...
Posted by Michael Wonder on 19 Nov 2020
Alvotech announces that the U.S. FDA and EMA have accepted regulatory submissions for AVT02, a proposed biosimilar to Humira (adalimumab)
19 November 2020 - Alvotech is developing AVT02 as a proposed biosimilar to Humira (adalimumab) with high concentration (100 mg/mL) dosage ...
Posted by Michael Wonder on 16 Nov 2020
EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain
16 November 2020 - EMA’s CHMP has started a ‘rolling review’ of data on a vaccine for COVID-19 known as ...
Posted by Michael Wonder on 12 Nov 2020
Janssen submits applications in U.S. and EU seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Darzalex (daratumumab) subcutaneous formulation in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma
12 November 2020 - Applications supported by positive results from the Phase 3 APOLLO trial, which demonstrated longer progression-free survival in ...
Posted by Michael Wonder on 10 Nov 2020
Bayer submits marketing authorization applications for finerenone in the U.S. and the EU for patients with chronic kidney disease and type 2 diabetes
9 November 2020 - Regulatory submissions based on positive data from Phase 3 FIDELIO-DKD trial recently published in the New England ...
Posted by Michael Wonder on 10 Nov 2020
Orphazyme submits European Marketing Authorisation application for arimoclomol for treatment of Niemann-Pick disease Type C
9 November 2020 - Follows U.S. FDA acceptance of new drug application with priority review in September 2020. ...
Posted 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 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
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
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 ...