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RSS FeedPosted by Michael Wonder on 30 Jul 2020
Imago BioSciences granted access by European Medicines Agency to PRIME scheme for IMG-7289 (bomedemstat) in myelofibrosis
30 July 2020 - Access granted on positive primary analysis of the ongoing Phase 2 trial to evaluate the safety and ...
Posted by Michael Wonder on 29 Jul 2020
Novartis receives Piqray approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation
29 July 2020 - Approval based on SOLAR-1 Phase III trial showing Piqray plus fulvestrant nearly doubled median PFS (11.0 vs. ...
Posted by Michael Wonder on 29 Jul 2020
BioMed Valley Discoveries’ ulixertinib (BVD-523), a first-in-class ERK inhibitor cancer therapy, receives fast track designation and launches Phase II trial in collaboration with Cmed and Strata Oncology
28 July 2020 - BioMed Valley Discoveries announces the receipt of fast track designation from the US FDA for investigation of ...
Posted by Michael Wonder on 28 Jul 2020
Janssen receives CHMP positive opinion for expanded use of Imbruvica (ibrutinib) in combination with rituximab for previously untreated patients with chronic lymphocytic leukaemia
24 July 2020 - Positive opinion is supported by Phase 3 E1912 study evaluating ibrutinib-rituximab combination versus chemo-immunotherapy in first-line treatment ...
Posted by Michael Wonder on 27 Jul 2020
Calquence recommended for approval in the EU by CHMP for chronic lymphocytic leukaemia
27 July 2020 - Recommendation based on two Phase III trials demonstrating superior progression-free survival across multiple settings while maintaining ...
Posted by Michael Wonder on 27 Jul 2020
Imfinzi recommended for approval in the EU by CHMP for extensive-stage small cell lung cancer
27 July 2020 - Only PD-1/PD-L1 immunotherapy to demonstrate a significant survival benefit and improved response rate in combination with a ...
Posted by Michael Wonder on 26 Jul 2020
GSK receives positive CHMP opinion recommending approval of belantamab mafodotin for the treatment of relapsed and refractory multiple myeloma
24 July 2020 - GlaxoSmithKline today announced the CHMP of the EMA adopted a positive opinion recommending the approval of belantamab ...
Posted by Michael Wonder on 17 Jul 2020
EMA validates Bristol Myers Squibb’s application for CAR T cell therapy lisocabtagene maraleucel
17 July 2020 - Application based on positive results from TRANSCEND NHL 001 study and additional TRANSCEND WORLD 001 study. ...
Posted by Michael Wonder on 14 Jul 2020
Aspen offers to cut cancer drug prices, may avoid EU antitrust fine
14 July 2020 - Aspen has offered to cut prices by an average of 73% for six off-patent cancer drugs, ...
Posted by Michael Wonder on 08 Jul 2020
Lynparza approved in the EU for BRCA mutated metastatic pancreatic cancer
8 July 2020 - Only PARP inhibitor approved in this disease. ...
Posted by Michael Wonder on 06 Jul 2020
EMA validates and grants accelerated assessment for trastuzumab deruxtecan for the treatment of HER2 positive metastatic breast cancer
6 July 2020 - Daiichi Sankyo today announced that the EMA has validated the marketing authorisation application for trastuzumab deruxtecan, ...
Posted by Michael Wonder on 02 Jul 2020
European Commission approves Daurisma (glasdegib) for certain adult patients with newly diagnosed acute myeloid leukaemia
30 June 2020 - Pfizer today announced that the European Commission approved Daurisma (glasdegib), a Hedgehog pathway inhibitor, in combination with ...
Posted by Michael Wonder on 29 Jun 2020
Daiichi Sankyo provides update on CHMP review of pexidartinib, a CSF1R inhibitor for the treatment of patients with TGCT
26 June 2020 - Daiichi Sankyo today announced that the Committee for Medicinal Products for Human Use of the European Medicines ...
Posted by Michael Wonder on 28 Jun 2020
ERC Belgium submits marketing authorisation application to European Medicines Agency for glioblastoma immunotherapy, Sitoiganap
26 June 2020 - ERC Belgium has announced that it has submitted to the EMA its marketing authorisation application for ...
Posted by Michael Wonder on 22 Jun 2020
European Medicines Agency validates application for Bavencio (avelumab) for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
22 June 2020 - Merck and Pfizer today announced that the EMA has validated for review the Type II variation ...