Blog
RSS FeedPosted by Michael Wonder on 01 Apr 2020
COVID-19 update: FDA continues to accelerate development of novel therapies for COVID-19
31 March 2020 - As part of the Trump Administration’s all-hands-on-deck approach across public, academic and private sectors to combat the ...
Posted by Michael Wonder on 01 Apr 2020
MEI Pharma announces fast track designation granted by U.S. FDA for ME-401 for the treatment of adult patients with relapsed or refractory follicular lymphoma
31 March 2020 - MEI Pharma today announced that the U.S. FDA granted fast track designation to ME-401, MEI's investigational selective ...
Posted by Michael Wonder on 31 Mar 2020
Advancing regulatory science in the EU – new strategy adopted
31 March 2020 - EMA has published its Regulatory Science Strategy to 2025 today. ...
Posted by Michael Wonder on 31 Mar 2020
Bristol Myers Squibb and bluebird bio announce submission of biologics license application for anti-BCMA CAR T cell therapy idecabtagene vicleucel (Ide-cel, bb2121) to FDA
31 March 2020 - Submission includes results from pivotal Phase 2 KarMMa study evaluating ide-cel in a heavily pre-treated patient ...
Posted by Michael Wonder on 31 Mar 2020
Expanded access as a source of real‐world data: an overview of FDA and EMA approvals
22 March 2020 - The authors set out to identify, characterise, and compare all FDA and EMA approvals that included real‐world ...
Posted by Michael Wonder on 31 Mar 2020
TGA publishes another AusPAR for Opdivo (nivolumab)
31 March 2020 - First apparent TGA rejection for nivolumab. ...
Posted by Michael Wonder on 31 Mar 2020
Expedited COVID-19 medical device application process
31 March 2020 - The Therapeutic Goods Administration is currently undertaking an expedited assessment process for all medical devices associated with ...
Posted by Michael Wonder on 31 Mar 2020
Nubeqa (darolutamide) receives EU approval as a new treatment for men with non-metastatic castration-resistant prostate cancer
30 March 2020 - Approval is based on Phase III ARAMIS trial results showing a statistically significant improvement in metastasis-free survival ...
Posted by Michael Wonder on 31 Mar 2020
Developing COVID-19 vaccines at pandemic speed
30 March 2020 - Rapid publication of a perspective co-authored by former head of Australian Department of Health. ...
Posted by Michael Wonder on 31 Mar 2020
Clinical trial processes
31 March 2020 - The TGA has received a number of enquiries about processes for clinical trials relating to COVID-19 ...
Posted by Michael Wonder on 31 Mar 2020
EMA validates marketing authorisation application for oral, once-daily berotralstat (BCX7353) to prevent HAE attacks
30 March 2020 - BioCryst Pharmaceuticals announced that the EMA has validated its marketing authorisation application submission for approval of ...
Posted by Michael Wonder on 30 Mar 2020
Trump administration in talks with India to avoid U.S. drug supply shortage
31 March 2020 - India, the top source of generic drugs and ingredients, has restricted exports but the U.S. wants exemptions ...
Posted by Michael Wonder on 30 Mar 2020
U.S. regulator approves limited use of malaria drugs for COVID-19
30 March 2020 - A limited emergency-use authorisation for two antimalarial drugs touted as game-changers by President Donald Trump has ...
Posted by Michael Wonder on 30 Mar 2020
Johnson & Johnson announces a lead vaccine candidate for COVID-19; landmark new partnership with U.S. Department of Health & Human Services; and commitment to supply one billion vaccines worldwide for emergency pandemic use
30 March 2020 - Company Expects to Initiate Phase 1 Human Clinical Studies of Vaccine Candidate at Latest by September 2020. ...
Posted by Michael Wonder on 30 Mar 2020
FDA guidance on conduct of clinical trials of medical products during the COVID-19 pandemic
30 March 2020 - The U.S. FDA today issued an updated guidance, “Conduct of Clinical Trials of Medical Products during ...