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RSS FeedPosted by Michael Wonder on 03 Feb 2020
GSK announces EMA accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma
3 February 2020 - Belantamab mafodotin accepted for accelerated assessment by the EMA’s CHMP. ...
Posted by Michael Wonder on 03 Feb 2020
Bayer receives positive CHMP opinion for darolutamide as a new treatment for men with non-metastatic castration-resistant prostate cancer
31 January 2020 - CHMP opinion is based on Phase III ARAMIS trial data evaluating the efficacy and safety of darolutamide ...
Posted by Michael Wonder on 03 Feb 2020
AbbVie receives positive CHMP opinion for Venclyxto as a chemotherapy-free combination regimen for patients with previously untreated chronic lymphocytic leukaemia
31 January 2020 - If approved by the European Commission, Venclyxto plus obinutuzumab would be the first chemotherapy-free, combination regimen given ...
Posted by Michael Wonder on 02 Feb 2020
EMA validates Seattle Genetics’ marketing authorisation application for tucatinib for patients with locally advanced or metastatic HER2-positive breast cancer
31 January 2020 - Application Supported by Results of Pivotal HER2CLIMB Trial. ...
Posted by Michael Wonder on 31 Jan 2020
Bristol-Myers Squibb withdraws European application of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of advanced non-small cell lung cancer
31 January 2020 - Company committed to first-line lung cancer patients in Europe, U.S. and other markets with planned filing of ...
Posted by Michael Wonder on 29 Jan 2020
Janssen announces European Commission approval for expanded use of Erleada (apalutamide) for treatment of patients with metastatic hormone-sensitive prostate cancer
29 January 2020 - Latest approval for apalutamide could benefit a population of more than 100,000 people living with mHSPC across ...
Posted by Michael Wonder on 21 Jan 2020
European Commission approves Roche’s Polivy for people with previously treated aggressive lymphoma
21 January 2020 - Novel combination regimen includes first-in-class antibody-drug conjugate that specifically targets CD79b. ...
Posted by Michael Wonder on 21 Jan 2020
Janssen seeks expanded use of Imbruvica (ibrutinib) in combination with rituximab for patients with previously untreated chronic lymphocytic leukaemia
20 January 2020 - Application supported by the Phase 3 E1912 study evaluating the use of ibrutinib in combination with rituximab, ...
Posted by Michael Wonder on 21 Jan 2020
European Commission approves Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are transplant eligible
20 January 2020 - Janssen announced today that the European Commission has granted marketing authorisation for Darzalex (daratumumab) in combination with ...
Posted by Michael Wonder on 08 Jan 2020
Incyte announces the validation by the European Medicines Agency of its marketing authorisation application for pemigatinib in patients with cholangiocarcinoma
7 January 2020 - Incyte today announced the validation of the Company’s marketing authorisation application for pemigatinib for the treatment of ...
Posted by Michael Wonder on 03 Jan 2020
EMA accepts regulatory submission for Lumoxiti in relapsed or refractory hairy cell leukaemia
2 January 2020 - Innate Pharma today announced that the EMA has accepted the marketing authorisation application for Lumoxiti (moxetumomab ...
Posted by Michael Wonder on 21 Dec 2019
Bristol-Myers Squibb receives European Commission approval for Revlimid (lenalidomide) in combination with rituximab for the treatment of adult patients with previously treated follicular lymphoma
20 December 2019 - Revlimid plus rituximab is the first chemotherapy-free combination regimen approved in Europe for patients with follicular lymphoma ...
Posted 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
CHMP issues positive opinion to expand Cyramza (ramucirumab) label to include results from RELAY study in patients with metastatic EGFR-mutated non-small cell lung cancer
13 December 2019 - Cyramza in combination with erlotinib recommended for approval in the EU for the first-line treatment of adult ...
Posted by Michael Wonder on 13 Dec 2019
CHMP grants positive opinion for expanded use of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are transplant eligible
13 December 2019 - If approved by the European Commission, the daratumumab-VTd regimen would represent the first therapeutic option indicated for ...