Blog
RSS FeedPosted by Michael Wonder on 10 Jun 2020
Mallinckrodt completes rolling submission of biologics license application for StrataGraft regenerative skin tissue to U.S. FDA
9 June 2020 - StrataGraft skin tissue is in development as potential new treatment option for patients with deep partial-thickness thermal ...
Posted by Michael Wonder on 09 Jun 2020
The US government's supply of the only proven COVID-19 drug runs out at the end of the month
8 June 2020 - The US government's current supply of remdesivir, the only drug known to work against COVID-19, will ...
Posted by Michael Wonder on 09 Jun 2020
BioCryst announces berotralstat expanded access program for patients with hereditary angioedema in United States
9 June 2020 - BioCryst Pharmaceuticals today announced that the company has established an expanded access program with oral, once-daily ...
Posted by Michael Wonder on 09 Jun 2020
The coronavirus pandemic is reigniting a fierce debate over compounded drugs
9 June 2020 - In hopes of alleviating potential drug shortages and other issues wrought by the coronavirus pandemic, the ...
Posted by Michael Wonder on 09 Jun 2020
Insmed receives FDA breakthrough therapy designation for brensocatib in patients with non-cystic fibrosis bronchiectasis
8 June 2020 - Full results from phase 2 WILLOW study of brensocatib in non-cystic fibrosis bronchiectasis to be presented at ...
Posted by Michael Wonder on 08 Jun 2020
CytoDyn receives BLA acknowledgment letter from the FDA
8 June 2020 - PDUFA date could be set by the FDA on 10 July. ...
Posted by Michael Wonder on 08 Jun 2020
U.K. lab to sidestep pharma industry to sell potential virus vaccine
7 June 2020 - Imperial College aims to develop a vaccine that is cheaper and easier to manufacture and is forming ...
Posted by Michael Wonder on 08 Jun 2020
The quest for a vaccine could restore faith in big pharma
4 June 2020 - The boffins of AstraZeneca are showing the way forward ...
Posted by Michael Wonder on 06 Jun 2020
AiCuris was granted breakthrough therapy designation by U.S. FDA for pritelivir for the treatment of HSV infections in immunocompromised patients
5 June 2020 - AiCuris is currently preparing to add a pivotal Phase 3 trial part to the ongoing Phase 2 ...
Posted by Michael Wonder on 04 Jun 2020
FDA re-evaluates user fees for biosimilar reviews
4 June 2020 - Even before the pandemic, the FDA was having trouble estimating its resource needs for biosimilar application reviews. ...
Posted by Michael Wonder on 04 Jun 2020
Trump Administration selects five coronavirus vaccine candidates as finalists
3 June 2020 - The Trump administration has selected five companies, including Moderna, AstraZeneca and Pfizer, as the most likely ...
Posted by Michael Wonder on 04 Jun 2020
The Lancet, New England Journal retract COVID-19 studies, including one that raised safety concerns about malaria drugs
4 June 2020 - The Lancet, one of the world’s top medical journals, on Thursday retracted an influential study that ...
Posted by Michael Wonder on 04 Jun 2020
Adamas announces FDA filing acceptance of sNDA to modify the indication statement for Gocovri to include treatment for Parkinson’s disease patients receiving levodopa and experiencing OFF episodes
4 June 2020 - Adamas Pharmaceuticals today announced that its supplemental new drug application for Gocovri as a treatment for OFF ...
Posted by Michael Wonder on 04 Jun 2020
FDA approves antibiotic to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
4 June 2020 - Today, the U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat ...
Posted by Michael Wonder on 04 Jun 2020
U.S. FDA accepts Pharmaessentia's application for ropeginterferon alfa-2b to treat polycythemia vera
4 June 2020 - U.S. team begins commercial preparations for novel pegylated interferon with appointment of General Manager Meredith Manning. ...