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RSS FeedPosted by Michael Wonder on 30 Jul 2020
FDA approves Genentech’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma
30 July 2020 - Genentech today announced that the U.S. FDA approved Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) ...
Posted by Michael Wonder on 30 Jul 2020
Pathological complete response in neo-adjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval
29 July 2020 - This guidance is intended to assist sponsors in designing trials to support marketing approval of medicines and ...
Posted by Michael Wonder on 29 Jul 2020
FDA grants breakthrough therapy designation to Merck’s novel HIF-2α inhibitor MK-6482 for treatment of certain patients with von Hippel-Lindau disease-associated renal cell carcinoma
29 July 2020 - Reinforces important progress in Merck’s oncology pipeline to advance novel therapeutic candidates. ...
Posted by Michael Wonder on 29 Jul 2020
Bristol Myers Squibb and bluebird bio announce submission of biologics license application to FDA for idecabtagene vicleucel (Ide-cel, bb2121) for adults with relapsed and refractory multiple myeloma
29 July 2020 - BLA submission based on results from pivotal Phase 2 KarMMa study evaluating ide-cel in heavily pre-treated patient ...
Posted by Michael Wonder on 29 Jul 2020
FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy
29 July 2020 - Developed with enhanced technology, this new assay provides high-quality staining with improved turnaround time. ...
Posted by Michael Wonder on 29 Jul 2020
Protara Therapeutics receives rare paediatric disease designation for TARA-002 for the treatment of lymphatic malformations
28 July 2020 - Protara Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for TARA-002 for ...
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
Black Diamond Therapeutics granted fast track designation by the FDA for BDTX-189 for the treatment of adult patients with a solid tumour harbouring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion mutation
28 July 2020 - Black Diamond Therapeutics today announced that the U.S. FDA granted fast track designation to BDTX-189 for the ...
Posted by Michael Wonder on 27 Jul 2020
Checkmate Pharmaceuticals granted FDA fast track designation for CMP-001 combined with PD-1 blockade in the treatment of certain types of metastatic or unresectable melanoma
27 July 2020 - Checkmate Pharmaceuticals today announced that the U.S. FDA granted fast track designation to its product candidate, ...
Posted by Michael Wonder on 24 Jul 2020
FDA approves first cell-based gene therapy for adult patients with relapsed or refractory mantle cell lymphoma
24 July 2020 - Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment ...
Posted by Michael Wonder on 17 Jul 2020
FDA grants fast track designation for DB102 in patients with newly diagnosed glioblastoma
17 July 2020 - Denovo Biopharma today announced that the U.S. FDA has granted fast track designation for DB102 (enzastaurin) being ...
Posted by Michael Wonder on 12 Jul 2020
COVID-19 is forcing us to rethink clinical trials for cancer treatments
9 July 2020 - Participation rates were already low, but the pandemic threatens to drive them even lower. ...
Posted by Michael Wonder on 09 Jul 2020
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for second-line treatment of patients with relapsed or refractory classical Hodgkin lymphoma
9 July 2020 - Application based on data comparing Keytruda to standard care (brentuximab vedotin) from pivotal Phase 3 KEYNOTE-204 trial. ...
Posted by Michael Wonder on 08 Jul 2020
Merck and Eisai receive complete response letter for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination as first-line treatment for unresectable hepatocellular carcinoma
8 July 2020 - Merck and Eisai today announced that the U.S. FDA has issued a complete response letter regarding Merck’s ...
Posted by Michael Wonder on 03 Jul 2020
MetVital announces FDA fast track designation of anhydrous enol-oxaloacetate for the treatment of patients with newly diagnosed glioblastoma multiforme
1 July 2020 - MetVital today announces that the U.S. FDA has notified MetVital that its lead drug candidate, "Anhydrous ...