Blog
RSS FeedPosted 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 10 Sep 2018
European Commission approves Merck’s Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations
10 September 2018 - European approval based on results from pivotal Phase 3 trial KEYNOTE-189 demonstrating Keytruda in combination with pemetrexed ...
Posted by Michael Wonder on 05 Sep 2018
European Commission grants marketing authorisation for Puma Biotechnology’s Nerlynx (neratinib) for extended adjuvant treatment of hormone receptor positive HER2 positive early stage breast cancer
4 September 2018 - Neratinib becomes the first anti-HER2 treatment to be EC-approved as extended adjuvant therapy for early stage hormone ...
Posted by Michael Wonder on 03 Sep 2018
Genmab announces European marketing authorisation for Darzalex (daratumumab) for front line multiple myeloma
31 August 2018 - Darzalex approved in Europe in combination with bortezomib, melphalan and prednisone in patients with newly diagnosed multiple ...
Posted by Michael Wonder on 28 Aug 2018
Loxo Oncology announces submission of European marketing authorisation application for larotrectinib
27 August 2018 - Loxo Oncology today announced that its collaboration partner, Bayer, has submitted a marketing authorisation application for larotrectinib ...
Posted by Michael Wonder on 27 Aug 2018
Vyxeos receives marketing authorisation in the European Union for treatment of certain types of high-risk acute myeloid leukaemia
27 August 2018 - Jazz Pharmaceuticals today announced that the European Commission approved Vyxeos 44 mg/100 mg powder for concentrate for ...
Posted by Michael Wonder on 24 Aug 2018
European Commission grants marketing authorisation for Lenvima (lenvatinib) as first-line treatment in adults with advanced or unresectable hepatocellular carcinoma
23 August 2018 - Eisai and Merck announced today that the European Commission has granted a marketing authorisation for the ...
Posted by Michael Wonder on 09 Aug 2018
Genmab announces submission of U.S. & EU regulatory applications seeking approval of Darzalex (daratumumab) split dosing regimen
8 August 2018 - Applications seek to update prescribing information and summary of product characteristics. ...
Posted by Michael Wonder on 31 Jul 2018
European Commission approves Bristol-Myers Squibb’s Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
31 July 2018 - Opdivo is the first and only PD-1 agent with an approved adjuvant therapy indication in the European ...
Posted by Michael Wonder on 30 Jul 2018
EMA adopts positive opinion for Keytruda (pembrolizumab) combination with pemetrexed and platinum chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer
30 July 2018 - KEYTRUDA combination improved overall survival compared with pemetrexed and platinum chemotherapy alone in pivotal Phase 3 trial ...
Posted by Michael Wonder on 29 Jul 2018
Braftovi (encorafenib) + Mektovi (binimetinib) receives positive CHMP opinion for advanced BRAF mutant melanoma
27 July 2018 - Positive CHMP opinion is based on Phase 3 COLUMBUS trial which demonstrated nearly 15 months median progression-free ...
Posted by Michael Wonder on 28 Jul 2018
Novartis combination Tafinlar + Mekinist receives positive CHMP opinion for adjuvant treatment of BRAF V600 mutation-positive melanoma
27 July 2018 - If approved, expected to be the first targeted combination therapy in the EU for adjuvant treatment ...
Posted by Michael Wonder on 05 Jul 2018
Clovis Oncology receives EMA validation for its application for a new indication for Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer
5 July 2018 - The filing is based on positive phase 3 ARIEL3 clinical trial data in which rucaparib significantly improved ...
Posted by Michael Wonder on 05 Jul 2018
European Commission approves expanded indication for Sprycel (dasatinib) to include treatment of children with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase
5 July 2018 - Approval includes the first powder for oral suspension formulation of a tyrosine kinase inhibitor developed for administration ...
Posted by Michael Wonder on 01 Jul 2018
European CHMP adopts positive opinion for Yescarta (axicabtagene ciloleucel) for the treatment of relapsed or refractory DLBCL and PMBCL, after two or more lines of systemic therapy
29 June 2018 - Kite, a Gilead Company, today announced that the EMA's CHMP has issued a positive opinion on the ...