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RSS FeedPosted by Michael Wonder on 18 Nov 2020
Does remdesivir actually work against COVID-19?
17 November 2020 - The evidence shows only that the drug might be effective. That once wasn’t enough for FDA approval. ...
Posted by Michael Wonder on 17 Nov 2020
FDA’s ongoing commitment to transparency for COVID-19 EUAs
17 November 2020 - Emergency use authorisations, or EUAs, are an important tool in our country’s fight against COVID-19 and other ...
Posted by Michael Wonder on 16 Nov 2020
HHS Secretary Azar says the FDA will move ‘as quickly as possible’ to clear Moderna and Pfizer’s COVID-19 vaccines
16 November 2020 - There should be enough vaccine doses made by Pfizer and Moderna to inoculate roughly 20 million before ...
Posted by Michael Wonder on 10 Nov 2020
The next big challenge after a COVID-19 vaccine is giving it to enough people
10 November 2020 - With Pfizer’s COVID-19 vaccine on track to be authorised as early as next month, Western governments ...
Posted by Michael Wonder on 10 Nov 2020
Pfizer’s and BioNTech’s vaccine is the start of the end of the pandemic
9 November 2020 - Its 90% effectiveness is as good as it gets, and bodes well for other vaccines. But getting ...
Posted by Michael Wonder on 09 Nov 2020
Novavax COVID-19 vaccine granted fast track designation by U.S. FDA
9 November 2020 - Novavax today announced that the U.S. FDA has granted fast track designation for NVX-CoV2373, the Company’s COVID-19 ...
Posted by Michael Wonder on 03 Nov 2020
The FDA's cutoff for COVID-19 vaccine effectiveness is 50 percent. What does that mean?
3 November 2020 - Over the summer, the FDA announced that in order for an experimental COVID-19 vaccine to get ...
Posted by Michael Wonder on 31 Oct 2020
Gilead’s COVID-19 drug is mediocre. It will be a blockbuster anyway.
29 October 2020 - Gilead Sciences said Wednesday that remdesivir, which has been authorised for emergency use since the spring, brought ...
Posted by Michael Wonder on 30 Oct 2020
How will a COVID vaccine be distributed once it's approved by FDA?
29 October 2020 - Distributing the first wave of doses will be a massive undertaking. ...
Posted by Michael Wonder on 29 Oct 2020
The FDA will not inspect vaccine production plants
29 October 2020 - Approval of a vaccine by the FDA typically requires inspection of the vaccine’s manufacturing plants. ...
Posted by Michael Wonder on 28 Oct 2020
Lilly announces agreement with U.S. government to supply 300,000 vials of investigational neutralising antibody bamlanivimab (LY-CoV555) in an effort to fight COVID-19
28 October 2020 - Initial agreement for 300,000 vials with potential for purchase of an additional 650,000 vials. ...
Posted by Michael Wonder on 27 Oct 2020
COVID-19 vaccine rollout calls for supply chain collaboration, logistics chief says
26 October 2020 - Kuehne + Nagel CEO Detlef Trefzger says rush will be manageable despite strains on transportation capacity. ...
Posted by Michael Wonder on 24 Oct 2020
FDA shows signs of cold feet over emergency authorisation of COVID-19 vaccines
23 October 2020 - There are serious signs the FDA is getting cold feet over the notion of issuing emergency ...
Posted by Michael Wonder on 22 Oct 2020
Oxford developed COVID-19 vaccine, then scholars clashed over money
21 October 2020 - Early deal with Merck was scotched for fear poor countries would be left out; now university could ...
Posted by Michael Wonder on 22 Oct 2020
Remdesivir’s hefty price tag ignores NIH investment in its creation
22 October 2020 - Throughout the Democratic presidential primary, candidates cast a spotlight on the broken U.S. health care system ...