Blog
RSS FeedPosted by Michael Wonder on 03 Mar 2021
CSL warns AstraZeneca booster shots not available until end of year
2 March 2021 - Australia’s COVID-19 vaccine maker CSL says it is open to making booster shots for AstraZeneca for ...
Posted by Michael Wonder on 02 Mar 2021
Drug industry pushes FDA to solve growing inspection backlog
2 March 2021 - Inspections are a vital tool to ensure the safety of new drugs as well as medicines already ...
Posted by Michael Wonder on 25 Feb 2021
Three steps can help companies speed FDA approval of new drugs
24 February 2021 - Drug developers see FDA approval as a difficult uphill climb, requiring large investments of resources and ...
Posted by Michael Wonder on 19 Feb 2021
Where is AstraZeneca’s vaccine? Health Canada says not yet ready to greenlight
18 February 2021 - Health Canada is not yet ready to make a decision about approving the COVID-19 vaccine from ...
Posted by Michael Wonder on 17 Feb 2021
COVID-19 vaccine approval process: does it take too long?
15 February 2021 - Here are answers to some questions about the FDA review panels. ...
Posted by Michael Wonder on 10 Feb 2021
EMA expected to approve Johnson & Johnson vaccine by March
10 February 2021 - The European Medicines Agency is expected to give its approval to the COVID-19 vaccine developed by ...
Posted by Michael Wonder on 10 Feb 2021
Due to aducanumab’s new PDUFA date, ICER extends timeline for Alzheimer’s disease assessment
10 February 2021 - The ICER announced today it has extended its timeline for assessing the comparative clinical effectiveness and ...
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 19 Jan 2021
Medicines NZ hopes country can roll out COVID-19 vaccines early
19 January 2021 - Medical professionals are hopeful New Zealand is in a position to roll out COVID-19 vaccines early. ...
Posted by Michael Wonder on 18 Jan 2021
FDA sped progress for most of 2020's novel drugs
14 January 2021 - Most novel drugs approved by the US FDA in 2020 made their way through the approvals process ...
Posted by Michael Wonder on 14 Jan 2021
COVID-19: NZ vaccine timeline remains the same in light of new variant strains
13 January 2021 - New Zealand does not have any plans to fast-track its Covid-19 vaccine roll-out in light of ...
Posted by Michael Wonder on 14 Jan 2021
Johnson & Johnson could apply for EMA approval in February
14 January 2021 - US pharmaceutical company Johnson & Johnson may submit an official application for approval of its COVID-19 ...
Posted by Michael Wonder on 11 Jan 2021
SMC to support innovative new medicines pathway
29 December 2020 - Experts from the Scottish Medicines Consortium are to support a new licensing and access pathway which ...
Posted by Michael Wonder on 04 Jan 2021
TGA still waiting for 'further data' on AstraZeneca vaccine
4 January 2020 - Concerns over new coronavirus cases in Sydney and Melbourne look unlikely to prompt an accelerated approval ...
Posted by Michael Wonder on 07 Dec 2020
FDA could authorise Pfizer’s COVID-19 vaccine this week as U.S. deaths surge
7 December 2020 - An FDA advisory group is scheduled to convene on Thursday to review Pfizer’s vaccine. ...