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
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
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 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 ...
Posted by Michael Wonder on 30 Mar 2020
FDA on signing of the COVID-19 Emergency Relief Bill, including landmark over-the-counter drug reform and user fee legislation
30 March 2020 - On Friday, the President signed into law a $2 trillion emergency relief bill that will continue ...
Posted by Michael Wonder on 30 Mar 2020
FDA approves durvalumab for extensive-stage small cell lung cancer
30 March 2020 - On 27 March 2020, the FDA approved durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either ...
Posted by Michael Wonder on 30 Mar 2020
Lilly's Taltz (ixekizumab) receives U.S. FDA approval for the treatment of paediatric patients with moderate to severe plaque psoriasis
30 March 2020 - Taltz is the first and only IL-17A antagonist approved to treat this population. ...
Posted by Michael Wonder on 29 Mar 2020
Infinity receives fast track designation for IPI-549 in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer
25 March 2020 - Infinity Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for IPI-549 in ...
Posted by Michael Wonder on 29 Mar 2020
Pharma’s future blockbusters laid up with coronavirus
27 March 2020 - Normally a haven during downturns, pharmaceuticals will see forthcoming products delayed as pandemic disrupts or delays clinical ...
Posted by Michael Wonder on 29 Mar 2020
IntelGenx receives complete response letter from FDA for Rizaport NDA
27 March 2020 - IntelGenx today announced that it has received a complete response letter from the U.S. FDA regarding ...