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RSS FeedPosted by Michael Wonder on 11 Nov 2021
FDA touts success and challenges in biosimilar development
10 November 2021 - A top official from the US FDA offered a mixed assessment of the agency’s biosimilars program, noting ...
Posted by Michael Wonder on 11 Nov 2021
Health tech questions await next FDA chief
10 November 2021 - Twenty months into the pandemic, the FDA remains consumed with vital decisions on coronavirus vaccines and treatments. ...
Posted by Michael Wonder on 11 Nov 2021
US FDA accepts supplemental new drug application and grants priority review for Jardiance for adults with heart failure independent of left ventricular ejection fraction
11 November 2021 - If approved, Jardiance would be the first clinically proven treatment for adults across the full spectrum ...
Posted by Michael Wonder on 11 Nov 2021
Valneva receives EU deal for COVID jab, and seeks apology from UK
11 November 2021 - French vaccine manufacturer, Valneva, has announced that it has won EU approval to supply up to 60 ...
Posted by Michael Wonder on 11 Nov 2021
COVID-19: EMA recommends authorisation of two monoclonal antibody medicines
11 November 2021 - EMA’s CHMP has recommended authorising Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19. ...
Posted by Michael Wonder on 11 Nov 2021
Moderna booster progress ‘well advanced’ as regulator considers child vaccines
11 November 2021 - Moderna’s coronavirus vaccine could be approved for use as a booster within weeks and the medical ...
Posted by Michael Wonder on 11 Nov 2021
COVID-19 vaccine weekly safety report (11 November 2021)
11 November 2021 - To 7 November 2021, the TGA has received 288 reports which have been assessed as likely to ...
Posted by Michael Wonder on 10 Nov 2021
Ellume's COVID-19 home test recall most serious, FDA says
10 November 2021 - The U.S. FDA classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the ...
Posted by Michael Wonder on 10 Nov 2021
Why TGA head John Skerritt must go over vaccine claim
10 November 2021 - The head of the TGA must resign or be sacked over his claims about the Moderna vaccine. ...
Posted by Michael Wonder on 10 Nov 2021
EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
10 November 2021 - EMA has started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to ...
Posted by Michael Wonder on 10 Nov 2021
Health Canada authorises the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine as a booster shot
9 November 2021 - Health Canada has authorized the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine as a booster shot. ...
Posted by Michael Wonder on 10 Nov 2021
Moderna's COVID-19 vaccine (Spikevax) - provisional determination granted for proposed use in children and booster shot for adults under evaluation
10 November 2021 - The TGA has granted a provisional determination to Moderna in relation to its COVID-19 vaccine, Spikevax. ...
Posted by Michael Wonder on 09 Nov 2021
Australia to wait for data from US children before clearing vaccine here
10 November 2021 - Australia’s top immunisation advisers will wait on safety data from at least several hundred thousand young ...
Posted by Michael Wonder on 09 Nov 2021
FDA’s Woodcock says agency has resumed normal review pace for biosimilars, generics
9 November 2021 - Janet Woodcock, MD, acting commissioner of the FDA, delivered an upbeat report on biosimilars and generics progress ...
Posted by Michael Wonder on 09 Nov 2021
Moderna files to expand the conditional marketing authorisation for its COVID-19 vaccine in the European Union to include children ages 6-11 years
9 November 2021 - Submission based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11. ...