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RSS FeedPosted by Michael Wonder on 31 Jan 2025
Highlights from the 27-30 January 2025 CHMP meeting
31 January 2025 - Eight new medicines recommended for approval; one positive opinion for a medicine intended for use outside the ...
Posted by Michael Wonder on 28 Jan 2025
GSK’s Shingrix new pre-filled syringe presentation accepted for review by EMA
27 January 2025 - If approved, the new presentation will offer a convenient administration option to healthcare professionals. ...
Posted by Michael Wonder on 19 Jan 2025
Protection against RSV for mums and bubs with free vaccine available from 3 February
19 January 2025 - From 3 February 2025, Australian mums and their newborn babies will have free access to the best ...
Posted by Michael Wonder on 13 Jan 2025
GSK’s Shingrix new pre-filled syringe presentation accepted for review by US FDA
10 January 2025 - An FDA decision on the application is expected by 20 June 2025. ...
Posted by Michael Wonder on 22 Dec 2024
LimmaTech awarded FDA fast track designation for vaccine candidate against Staphylococcus aureus
19 December 2024 - LimmaTech Biologics announced today that the US FDA has granted fast track designation to LimmaTech’s multivalent ...
Posted by Michael Wonder on 13 Dec 2024
UK MHRA grants innovation passport designation to ILiAD Biotechnologies BPZE1 next generation intranasal pertussis vaccine
4 December 2024 - ILiAD Biotechnologies today announced that the UK MHRA has granted Innovation Passport designation to BPZE1, the leading ...
Posted by Michael Wonder on 12 Dec 2024
Two combination vaccine candidates for prevention of influenza and COVID-19 granted fast track designation in the US
11 December 2024 - Two Phase 1/2 clinical studies are ongoing to evaluate the safety profile and immune response induced by ...
Posted by Michael Wonder on 10 Dec 2024
Moderna’s mRNA vaccines to be exempted from advisory committee scrutiny under $2 billion Morrison era deal
10 December 2024 - Critics say exemption ‘deeply concerning’ and risks creating separate assessment systems. ...
Posted by Michael Wonder on 05 Dec 2024
GSK’s fully liquid Menveo meningococcal vaccine approved by European Commission
27 November 2024 - New fully liquid presentation means reconstitution is not needed before use. ...
Posted by Michael Wonder on 04 Dec 2024
Valneva submits label extension application for its Chikungunya vaccine, Ixchiq, to the US FDA
26 November 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted by Michael Wonder on 17 Nov 2024
MHRA approves adapted Nuvaxovid JN.1 COVID-19 vaccine for adults and children aged 12 plus
15 November 2024 - The MHRA has approved an adapted version of the Nuvaxovid COVID-19 vaccine that targets the Omicron JN.1 ...
Posted by Michael Wonder on 13 Nov 2024
How the Morrison Government passed over an Australian company for a US pharmaceutical giant
13 November 2024 - Australia’s audit office will probe the Morrison Government’s $2 billion deal with US pharmaceutical giant Moderna ...
Posted by Michael Wonder on 11 Nov 2024
World leading approach to protect babies from RSV
10 November 2024 - Australian mums and their newborn babies will have free access to the best and most comprehensive ...
Posted by Michael Wonder on 09 Nov 2024
Moderna receives Health Canada approval for RSV vaccine for adults aged 60 years and older
8 November 2024 - mRESVIA is Moderna's second approved product in Canada, the first mRNA vaccine against RSV, and the only ...
Posted by Michael Wonder on 06 Nov 2024
Expanded age indication for GSK's Arexvy, the first respiratory syncytial virus vaccine approved in Canada for adults aged 50-59 at increased risk
5 November 2024 - Clinical development program continues to evaluate safety and immunogenicity in adults aged 18-49 at increased risk ...