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RSS FeedPosted by Michael Wonder on 29 Jan 2021
EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU
29 January 2021 - COVID-19 Vaccine AstraZeneca is now authorised across the EU. This follows the granting of a conditional marketing ...
Posted by Michael Wonder on 29 Jan 2021
Biogen and Eisai announce FDA's 3 month extension of review period for the biologics license application for aducanumab
29 January 2021 - The new Prescription Drug User Fee Act action date set by the FDA is 7 June ...
Posted by Michael Wonder on 29 Jan 2021
First COVID-19 vaccine safety update published
29 January 2021 - Today EMA has released its first safety update on a COVID-19 vaccine — Comirnaty. ...
Posted by Michael Wonder on 29 Jan 2021
AstraZeneca vaccine warnings based on maths, not safety
29 January 2021 - The warning from the German health ministry’s vaccine committee that the AstraZeneca jab should not be ...
Posted by Michael Wonder on 28 Jan 2021
Germany moves to exclude seniors from AstraZeneca’s COVID-19 vaccine
28 January 2021 - Ahead of its expected approval for use by Europe’s medicines regulator Friday, Germany’s vaccine committee has recommended ...
Posted by Michael Wonder on 28 Jan 2021
AstraZeneca, Pfizer hope to meet vaccine supply dates despite ‘fluid’ Europe situation
28 January 2021 - Pfizer and AstraZeneca warn global supply chain issues and the European Union’s plan to add control ...
Posted by Michael Wonder on 28 Jan 2021
M6P Therapeutics receives six rare paediatric disease designations from the U.S. FDA for company’s deep pipeline of programs for lysosomal storage disorders
28 January 2021 - U.S. FDA also grants two orphan drug designations for the company’s gene therapy programs for Gaucher disease ...
Posted by Michael Wonder on 28 Jan 2021
Bio-Thera Solutions announces FDA accepts biologics license application for BAT1706, a proposed biosimilar to Avastin
28 January 2021 - Bio-Thera Solutions today announced that the U.S. FDA has accepted its biologics license application for BAT1706, a ...
Posted by Michael Wonder on 28 Jan 2021
Advocacy groups urge Biden administration not to tap Woodcock as FDA commissioner
27 January 2021 - As the Biden White House attempts to fashion its health policies, a coalition of consumer and ...
Posted by Michael Wonder on 28 Jan 2021
Clarification of Comirnaty dosage interval
28 January 2021 - EMA’s human medicines committee (CHMP) has updated the product information for the COVID-19 vaccine Comirnaty to ...
Posted by Michael Wonder on 28 Jan 2021
TGA to rule on psychedelic drug access for mental health problems
28 January 2021 - A group of prominent Australians is continuing to push for greater access to psychedelic drugs to ...
Posted by Michael Wonder on 27 Jan 2021
E.U. and U.K. fighting over scarce vaccines
27 January 2021 - As vaccine production falls behind schedule, and the European Union lags in inoculating people, Brussels and London ...
Posted by Michael Wonder on 27 Jan 2021
EU demands UK made AstraZeneca vaccine doses
27 January 2021 - The EU has urged pharmaceutical firm AstraZeneca to supply it with more doses of its COVID-19 ...
Posted by Michael Wonder on 27 Jan 2021
European Medicines Agency accepts GBT’s marketing authorisation application for Oxbryta (voxelotor) for the treatment of haemolytic anemia in sickle cell disease
27 January 2021 - Global Blood Therapeutics today announced that the EMA has completed the validation of GBT’s marketing authorisation application ...
Posted by Michael Wonder on 27 Jan 2021
Australia’s COVID-19 vaccine information campaign begins
27 January 2021 - The Australian Government’s $23.9 million public information campaign to encourage Australians to get a COVID-19 vaccine begins ...