Blog
RSS FeedPosted by Michael Wonder on 21 Nov 2018
Roche pulls EU Tecentriq/Avastin filing in kidney cancer
19 November 2018 - Another setback for Roche, but CHMP changes its mind on Opdivo/Yervoy. ...
Posted by Michael Wonder on 21 Nov 2018
Janssen seeks expanded use of Imbruvica (ibrutinib) in two indications in Europe
14 November 2018 - Applications submitted to the EMA for new combinations in adult patients with chronic lymphocytic leukaemia and Waldenström's ...
Posted by Michael Wonder on 10 Nov 2018
Jazz Pharmaceuticals submits marketing authorisation application to EMA for solriamfetol as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnoea
9 November 2018 - Jazz Pharmaceuticals today announced the submission of a marketing authorisation application to the EMA for solriamfetol, a ...
Posted by Michael Wonder on 06 Nov 2018
Sankyo’s FLT3 inhibitor quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
5 November 2018 - Application based on results of pivotal phase 3 QuANTUM-R study of quizartinib in patients with relapsed/refractory FLT3-ITD ...
Posted by Michael Wonder on 20 Oct 2018
Bristol-Myers Squibb provides update on the ongoing regulatory review of Opdivo plus low dose Yervoy in first-line lung cancer patients with tumour mutational burden ≥10 mut/Mb
19 October 2018 - New analysis submitted to U.S. FDA constitutes a major amendment to the Company’s supplemental biologics license application. ...
Posted by Michael Wonder on 18 Oct 2018
Achaogen submits marketing authorisation application to the EMA for plazomicin
17 October 2018 - Submission for complicated urinary tract infections, bloodstream infections, and infections due to Enterobacteriaceae in adult patients ...
Posted by Michael Wonder on 11 Oct 2018
Rigel receives EMA validation of the marketing authorisation application for fostamatinib disodium hexahydrate in chronic immune thrombocytopenia in adult patients
11 October 2018 - First SYK inhibitor for the treatment of adult chronic ITP. ...
Posted by Michael Wonder on 11 Oct 2018
Janssen submits European marketing authorisation application for esketamine nasal spray for treatment-resistant depression
10 October 2018 - Data from five pivotal Phase 3 studies submitted as the basis for marketing authorisation application for ...
Posted by Michael Wonder on 09 Oct 2018
Aerie Pharmaceuticals announces drug application for regulatory approval accepted for review in Europe
9 October 2018 - EMA will begin review of the marketing authorisation application for Rhokiinsa (netarsudil ophthalmic solution) 0.02%, currently ...
Posted by Michael Wonder on 08 Oct 2018
Novartis announces FDA and EMA filing acceptance of siponimod, the first and only drug shown to meaningfully delay disability progression in typical SPMS patients
8 October 2018 - If approved, siponimod (BAF312) would be the first oral disease-modifying therapy with the potential to delay progression ...
Posted by Michael Wonder on 06 Oct 2018
bluebird bio announces EMA’s acceptance of marketing authorisation application for lentiGlobin gene therapy for the treatment of transfusion-dependent β-thalassemia
5 October 2018 - EMA will evaluate lentiGlobin marketing authorisation application under accelerated assessment. ...
Posted by Michael Wonder on 05 Oct 2018
Paratek announces acceptance of European marketing authorisation application for oral and intravenous omadacycline
4 October 2018 - MAA submission for both community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. ...
Posted by Michael Wonder on 18 Sep 2018
EMA validates Bristol-Myers Squibb’s application for Empliciti (elotuzumab) plus pomalidomide and low dose dexamethasone in patients with multiple myeloma
18 September 2018 - Bristol-Myers Squibb today announced that the EMA has validated the Company’s type II variation application for ...
Posted by Michael Wonder on 17 Sep 2018
EMA validates marketing authorisation application for Trogarzo
14 September 2018 - Theratechnologies is pleased to announce that the EMA has confirmed the validity of the marketing authorization ...
Posted by Michael Wonder on 14 Sep 2018
ViiV Healthcare submits regulatory application to EMA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV
14 September 2018 - ViiV Healthcare today announced submission of a marketing authorisation application to the EMA for a single-tablet, ...