Blog
RSS FeedPosted by Michael Wonder on 18 Dec 2019
U.S. FDA accepts and grants priority review to sNDA for Braftovi (encorafenib) in combination with Erbitux (cetuximab) (Braftovi doublet) for the treatment of BRAF V600E-mutant metastatic colorectal cancer after prior therapy
18 December 2019 - Pfizer today announced that the U.S. FDA has accepted and granted priority review to the Company’s supplemental ...
Posted by Michael Wonder on 16 Dec 2019
Diurnal submits marketing application to European regulators for congenital adrenal hyperplasia treatment
16 December 2019 - Significant opportunity to address unmet patient need, in a market estimated at $250 million. ...
Posted by Michael Wonder on 14 Dec 2019
ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir for children living with HIV
13 December 2019 - If approved, this new formulation of DTG will be the first integrase inhibitor available as a dispersible ...
Posted by Michael Wonder on 03 Dec 2019
EMA accepts for review marketing authorisation application for Amarin's icosapent ethyl (Vascepa) for reduction of cardiovascular risk in high-risk patients, as reflected in REDUCE-IT study
2 December 2019 - Amarin Corporation announced today that the EMA has validated the marketing authorisation application seeking approval for icosapent ...
Posted by Michael Wonder on 02 Dec 2019
Orchard Therapeutics announces the filing and validation of marketing authorisation application by EMA for OTL-200 for the treatment of metachromatic leukodystrophy
2 December 2019 - Application Being Evaluated Under Accelerated Assessment. ...
Posted by Michael Wonder on 26 Nov 2019
Verastem Oncology announces submission of a marketing authorisation application to the European Medicines Agency for Copiktra (duvelisib)
25 November 2019 - Verastem today announced the submission of a marketing authorisation application to the European Medicines Agency for Copiktra ...
Posted by Michael Wonder on 22 Nov 2019
BioMarin submits marketing authorisation application to EMA for valoctocogene roxaparvovec to treat severe haemophilia A
21 November 2019 - First marketing application submission for gene therapy directed at any type of haemophilia. ...
Posted by Michael Wonder on 21 Nov 2019
Paion announces submission of the marketing authorisation application for remimazolam in procedural sedation to the European Medicines Agency
20 November 2019 - The Specialty Pharma Company Paoin today announces that a marketing authorisation application for remimazolam, Paion’s ultra-short-acting ...
Posted by Michael Wonder on 13 Nov 2019
Actelion withdraws regulatory filings to extend the indication of Opsumit (macitentan 10mg) in CTEPH
12 November 2019 - Actelion Pharmaceuticals has announced its decision to voluntarily withdraw the European and other health authority filings ...
Posted by Michael Wonder on 09 Nov 2019
Johnson & Johnson announces submission of European marketing authorisation applications for Janssen’s investigational Ebola vaccine regimen
7 November 2019 - Data from multiple preclinical, Phase 1, 2 and 3 studies support applications, which have been granted Accelerated ...
Posted by Michael Wonder on 07 Nov 2019
EMA validates Bratovi, Mektovi application for some mCRC
7 November 2019 - The EMA has validated Pierre Fabre’s application for a Braftovi (encorafenib) and Mektovi (binimetinib) combination for ...
Posted by Michael Wonder on 01 Nov 2019
Vertex announces EMA marketing authorisation application validation for VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination treatment in cystic fibrosis
31 October 2019 - Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages ...
Posted by Michael Wonder on 30 Oct 2019
EMA and FDA accept marketing applications for Chugai's satralizumab in neuromyelitis optica spectrum disorder
30 October 2019 - The applications will be reviewed under accelerated assessment by EMA. ...
Posted by Michael Wonder on 23 Oct 2019
Janssen seeks to expand use of Tremfya (guselkumab) in the treatment of adults with active psoriatic arthritis
23 October 2019 - If approved, guselkumab will be the first selective IL-23 p19 subunit inhibitor for people in the European ...
Posted by Michael Wonder on 18 Oct 2019
Paratek withdraws European marketing authorisation application for oral and intravenous Nuzyra in skin infections and pneumonia
17 October 2019 - Application approvable by EMA for skin infections based on two Phase 3 studies. ...