Blog
RSS FeedPosted by Michael Wonder on 31 Jan 2021
Amarin receives positive CHMP opinion for icosapent ethyl for cardiovascular risk reduction
29 January 2021 - Positive opinion is based on extensive clinical study results, including results of the REDUCE-IT cardiovascular outcomes trial. ...
Posted by Michael Wonder on 31 Jan 2021
Medicines Australia’s position on potential European Union restrictions and vaccines supply
30 January 2021 - Medicines Australia is concerned by the reports of proposals from Europe that could impact the global ...
Posted by Michael Wonder on 30 Jan 2021
TGA approves first new medicine for 2021
31 January 2021 - The TGA approved Aklief (trifarotene) for the topical treatment of acne vulgaris of the face and/or the ...
Posted by Michael Wonder on 30 Jan 2021
Phase 1 drug candidate GLR2007 developed by Gan & Lee has been granted fast track designation by the U.S. FDA
29 January 2021 - Gan & Lee Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for GLR2007, ...
Posted by Michael Wonder on 29 Jan 2021
EU bans coronavirus vaccine exports to Australia
30 January 2021 - The European Commission has slapped an immediate export ban on coronavirus vaccines to Australia so European ...
Posted by Michael Wonder on 29 Jan 2021
Novartis receives positive CHMP opinion for Kesimpta (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis
29 January 2021 - CHMP opinion is based on two Phase 3 ASCLEPIOS trials that met the primary outcomes where Kesimpta ...
Posted by Michael Wonder on 29 Jan 2021
Highlights from 25-29 January 2021 CHMP meeting
29 January 2021 - EMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its January 2021 meeting. ...
Posted 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 ...