Blog
RSS FeedPosted by Michael Wonder on 12 Dec 2017
FDA accepts supplemental biologics license application, assigns priority review to Merck’s Keytruda (pembrolizumab) for treatment of relapsed or refractory primary mediastinal large B-cell lymphoma
11 December 2017 - Data for Keytruda in patients with relapsed or refractory PMBCL show overall response rate of 41% ...
Posted by Michael Wonder on 11 Dec 2017
Rhizen Pharmaceuticals S.A. receives FDA fast track designation for RP6530 (tenalisib), a highly selective dual PI3K delta/gamma inhibitor for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma
9 December 2017 - Rhizen Pharmaceuticals today announced that the U.S. FDA has granted fast track Designation for RP6530 (tenalisib), the ...
Posted by Michael Wonder on 06 Dec 2017
Clovis announces priority review designation for rucaparib supplemental new drug application
5 December 2017 - Priority review granted based on positive data from phase 3 ARIEL3 clinical trial in which rucaparib significantly ...
Posted by Michael Wonder on 06 Dec 2017
FDA grants Genentech’s Avastin full approval for most aggressive form of brain cancer
5 December 2017 - Genentech announced today that the U.S. FDA has granted full approval for Avastin (bevacizumab) for the ...
Posted by Michael Wonder on 02 Dec 2017
Arog Pharmaceuticals receives FDA fast track designation for crenolanib in relapsed or refractory FLT3-positive AML
1 December 2017 - Arog Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for crenolanib for ...
Posted by Michael Wonder on 01 Dec 2017
FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers
30 November 2017 - Agencies’ parallel review process makes test for efficient identification of multiple targeted therapy options available to health ...
Posted by Michael Wonder on 29 Nov 2017
U.S. FDA grants fast track designation for Idera Pharmaceuticals’ IMO-2125 in combination with ipilimumab for treatment of PD-1 refractory metastatic melanoma
29 November 2017 - Phase 3 trial initiation planned for first quarter 2018. ...
Posted by Michael Wonder on 28 Nov 2017
Kyowa Hakko Kirin announces FDA acceptance for filing and priority review designation of mogamulizumab’s biologics license application
28 November 2017 - Kyowa Hakko Kirin today announces that the U.S. FDA has accepted for review the biologics license ...
Posted by Michael Wonder on 22 Nov 2017
The promise and challenges of CAR-T gene therapy
22 November 2017 - The recent approvals of 2 one-time gene therapies for refractory paediatric acute lymphoblastic leukaemia and adult relapsed ...
Posted by Michael Wonder on 22 Nov 2017
Re-evaluating eligibility criteria for oncology clinical trials: analysis of investigational new drug applications in 2015
22 November 2017 - Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. ...
Posted by Michael Wonder on 22 Nov 2017
Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement
22 November 2017 - Excessive or overly restrictive eligibility criteria can slow trial accrual, jeopardise the generalisability of results, and limit ...
Posted by Michael Wonder on 21 Nov 2017
FDA approval of tisagenlecleucel
21 November 2017 - Promise and complexities of a $475, 000 cancer drug. ...
Posted by Michael Wonder on 21 Nov 2017
Janssen submits application to U.S. FDA to expand indication for Darzalex (daratumumab) combination therapy for patients with newly diagnosed multiple myeloma who are transplant ineligible
21 November 2017 - Supplemental biologics license application seeks first indication for Darzalex for the treatment of newly diagnosed patients. ...
Posted by Michael Wonder on 21 Nov 2017
FDA grants breakthrough therapy designation and orphan drug designation to PellePharm for topical patidegib in Gorlin syndrome
20 November 2017 - PellePharm today announced that the U.S. FDA has granted both breakthrough therapy designation and orphan drug ...
Posted by Michael Wonder on 17 Nov 2017
Celgene and bluebird bio announce bb2121 anti-BCMA CAR-T cell therapy has been granted breakthrough therapy designation from FDA and PRIME eligibility from EMA for relapsed and refractory multiple myeloma
16 November 2017 - Designations based on preliminary clinical data from ongoing phase I study of bb2121 in heavily pre-treated multiple ...