Blog
RSS FeedPosted by Michael Wonder on 10 Jul 2019
FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma
10 July 2019 - The U.S. FDA has accepted for review the biologics license application for isatuximab for the treatment ...
Posted by Michael Wonder on 02 Jul 2019
Libtayo (cemiplimab) approved for advanced cutaneous squamous cell carcinoma in the European Union
1 July 2019 - Libtayo is the only treatment approved in the EU for adult patients with metastatic or locally advanced ...
Posted by Michael Wonder on 02 Jul 2019
CHMP recommends EU approval of Roche’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer
28 June 2019 - First positive Phase III cancer immunotherapy study for people with metastatic triple-negative breast cancer. ...
Posted by Michael Wonder on 24 Jun 2019
European Commission approves Talzenna (talazoparib) for patients with inherited (germ-line) BRCA-mutated locally advanced or metastatic breast cancer
21 June 2019 - Only once-daily PARP inhibitor approved in Europe for hereditary breast cancer. ...
Posted by Michael Wonder on 18 Jun 2019
Lynparza (olaparib) approved in the EU for use as first-line maintenance therapy in patients with BRCA mutated advanced ovarian cancer
18 June 2019 - Lynparza is the only PARP inhibitor approved in the EU for this indication. ...
Posted by Michael Wonder on 05 Jun 2019
Janssen seeks to expand use of Erleada (apalutamide) in the treatment of patients with metastatic hormone-sensitive prostate cancer
4 June 2019 - Application supported by data from the Phase 3 TITAN study which were recently presented at the ...
Posted by Michael Wonder on 17 May 2019
Celgene receives European Commission approvals for Revlimid (lenalidomide) and Imnovid (pomalidomide)-based triplet combination regimens for patients with multiple myeloma
16 May 2019 - The European Commission has approved two of Celgene’s IMiD based combination regimens. ...
Posted by Michael Wonder on 08 May 2019
European Commission approves Lorviqua (lorlatinib) for certain adult patients with previously treated ALK positive advanced non-small cell lung cancer
7 May 2019 - Pfizer today announced that the European Commission granted conditional marketing authorisation for Lorviqua (lorlatinib, available in ...
Posted by Michael Wonder on 28 Apr 2019
Pfizer receives positive CHMP opinion for Talzenna (talazoparib) for patents with inherited (germline) BRCA mutated locally advanced or metastatic breast cancer
26 April 2019 - Positive opinion based on results from largest Phase 3 trial performed to date of a PARP inhibitor ...
Posted by Michael Wonder on 28 Apr 2019
CHMP issues positive opinion for Libtayo (cemiplimab) in advanced cutaneous squamous cell carcinoma
26 April 2019 - Currently no approved treatments in the European Union for advanced cutaneous squamous cell carcinoma. ...
Posted by Michael Wonder on 11 Apr 2019
Lynparza approved in EU for the treatment of germline BRCA-mutated HER2-negative advanced breast cancer
10 April 2019 - AstraZeneca and MSD’s Lynparza reduced the risk of disease progression or death by 42% vs. chemotherapy ...
Posted by Michael Wonder on 10 Apr 2019
Pixuvri (pixantrone) receives positive CHMP opinion to convert conditional approval into standard marketing authorisation in patients with aggressive non-Hodgkin B-cell lymphoma
9 April 2019 - Servier today announced that the CHMP of the EMA has issued a positive opinion for Pixuvri ...
Posted by Michael Wonder on 09 Apr 2019
Minimal residual disease as a surrogate outcome for product development for multiple myeloma: comparing FDA and EMA guidances
8 April 2019 - This article discusses the need to update regulatory science to include the use of minimal residual disease ...
Posted by Michael Wonder on 04 Apr 2019
EMA grants PRIME designation to Janssen’s investigational CAR-T therapy
4 April 2019 - Johnson & Johnson’s Janssen has announced the granting of a PRIME (PRIority MEdicines) designation for its ...
Posted by Michael Wonder on 04 Apr 2019
EMA validates Daiichi Sankyo’s marketing authorisation application for pexidartinib for treatment of patients with TGCT, a rare, debilitating, non-malignant tumour
4 April 2019 - EU marketing authorisation application follows recent filing of the pexidartinib new drug application by the U.S. FDA ...