Blog
RSS FeedPosted by Michael Wonder on 20 Mar 2020
Generating comparative evidence on new drugs and devices before approval
21 March 2020 - Fewer than half of new drugs have data on their comparative benefits and harms against existing treatment ...
Posted by Michael Wonder on 20 Mar 2020
Novartis commits to donate up to 130 million doses of hydroxychloroquine to support the global COVID-19 pandemic response
20 March 2020 - Hydroxychloroquine and a related drug, chloroquine, are currently under evaluation in clinical trials for the treatment of ...
Posted by Michael Wonder on 20 Mar 2020
US FDA issues complete response letter for empagliflozin 2.5 mg as adjunct to insulin for adults with type 1 diabetes
20 March 2020 - The U.S. FDA has issued a complete response letter for the supplemental new drug application of ...
Posted by Michael Wonder on 20 Mar 2020
Coronavirus vindicates capitalism
19 March 2020 - Drug companies will save lives, even as Bernie Sanders is denouncing them. ...
Posted by Michael Wonder on 19 Mar 2020
FDA to fast track clinical trials for coronavirus therapies
19 March 2020 - FDA Commissioner Stephen Hahn said the agency will test chloroquine, an anti-malarial drug, as a coronavirus treatment. ...
Posted by Michael Wonder on 19 Mar 2020
Coronavirus: Donald Trump announces two drugs will be made available to treat illness
20 March 2020 - Donald Trump has announced two “game changer” drugs will be made available “almost immediately” to treat coronavirus. ...
Posted by Michael Wonder on 19 Mar 2020
Coronavirus (COVID-19) update: FDA continues to facilitate development of treatments
19 March 2020 - The U.S. FDA continues to play a critical role in the multifaceted all-of-government response to the ...
Posted by Michael Wonder on 19 Mar 2020
FDA approves new treatment for paediatric patients with any strain of hepatitis C
19 March 2020 - The U.S. Food and Drug Administration today approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to ...
Posted by Michael Wonder on 19 Mar 2020
Janssen submits ponesimod new drug application to the U.S. FDA for treatment of adults with relapsing multiple sclerosis
19 March 2020 - Janssen today announced the submission of a new drug application to the U.S. FDA for ponesimod ...
Posted by Michael Wonder on 18 Mar 2020
Coronavirus (COVID-19) update: FDA focuses on safety of regulated products while scaling back domestic inspections
18 March 2020 - Protecting the health and safety of our staff and their families is of paramount concern to ...
Posted by Michael Wonder on 18 Mar 2020
Biohaven's verdiperstat receives fast track designation for the treatment of multiple system atrophy
18 March 2020 - Biohaven Pharmaceutical announced today that the Company's myeloperoxidase inhibitor, verdiperstat, received Fast Track designation from the US ...
Posted by Michael Wonder on 18 Mar 2020
Hundreds of scientists scramble to find a Coronavirus treatment
17 March 2020 - In an ambitious international collaboration, researchers have “mapped” proteins in the coronavirus and identified 50 drugs to ...
Posted by Michael Wonder on 18 Mar 2020
Coronavirus (COVID-19) update: FDA issues guidance for conducting clinical trials
18 March 2020 - The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review ...
Posted by Michael Wonder on 18 Mar 2020
DBV Technologies provides update on Viaskin Peanut BLA for children ages 4-11 years
16 March 2020 - DBV Technologies today announced that the U.S. FDA has informed the Company that during its ongoing review ...
Posted by Michael Wonder on 17 Mar 2020
Mallinckrodt completes rolling submission of new drug application to the U.S. FDA for terlipressin for the treatment of patients with hepatorenal syndrome type 1
17 March 2020 - Terlipressin would be the first FDA approved treatment option in the United States for adult patients with ...