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RSS FeedPosted by Michael Wonder on 28 Jun 2023
2023-24 cost recovery implementation statement for listing medicines on the PBS and designated vaccines on the NIP
28 June 2023 - 2023-24 Pharmaceutical Benefits Scheme and National Immunisation Program cost recovery fees commence on 1 July 2023. ...
Posted by Michael Wonder on 27 Jun 2023
AC Immune receives FDA fast track designation for anti-amyloid beta active immunotherapy, ACI-24.060, to treat Alzheimer’s disease
27 June 2023 - Initial PET data on amyloid plaque reduction in Alzheimer's disease expected H1, 2024. ...
Posted by Michael Wonder on 27 Jun 2023
GSK receives US FDA fast track designation for investigational vaccine against gonorrhoea
27 June 2023 - Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to ...
Posted by Michael Wonder on 26 Jun 2023
Japan’s Ministry of Health, Labour and Welfare approves Shingrix for the prevention of shingles in at-risk adults aged 18 and over
26 June 2023 - Shingrix (recombinant zoster vaccine) is already approved in Japan for adults aged 50 and over. ...
Posted by Michael Wonder on 24 Jun 2023
Pfizer and BioNTech submit applications to US FDA for Omicron XBB.1.5 adapted monovalent COVID-19 vaccine
23 June 2023 - The submissions reflect guidance from FDA and other major health authorities to provide COVID-19 vaccines better matched ...
Posted by Michael Wonder on 23 Jun 2023
Moderna files for FDA authorisation of its updated COVID-19 vaccine
22 June 2023 - Preliminary clinical data demonstrated a robust immune response by the company's XBB.1.5 monovalent vaccine against XBB descendent ...
Posted by Michael Wonder on 08 Jun 2023
European Commission authorises GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults
7 June 2023 - The authorisation is based on Phase 3 efficacy data in older adults. ...
Posted by Michael Wonder on 06 Jun 2023
EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants
6 June 2023 - The European Centre for Disease Prevention and Control and the European Medicines Agency have issued a ...
Posted by Michael Wonder on 01 Jun 2023
US FDA approves Abrysvo, Pfizer’s vaccine for the prevention of respiratory syncytial virus in older adults
31 May 2023 - FDA’s decision is based on the data from the pivotal Phase 3 clinical trial in approximately 37,000 ...
Posted by Michael Wonder on 01 Jun 2023
SK bioscience receives marketing authorisation of COVID-19 Vaccine from UK MHRA
30 May 2023 - SKYCovion is the world's first-ever vaccine developed utilising the RoseTTAFold, a software tool that uses deep learning. ...
Posted by Michael Wonder on 30 May 2023
Valneva files for Chikungunya vaccine authorisation with Health Canada
30 May 2023 - Valneva today announces the filing of a regulatory application with Health Canada for marketing approval of ...
Posted by Michael Wonder on 30 May 2023
Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants
30 May 2023 - International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and ...
Posted by Michael Wonder on 30 May 2023
ATAGI advice on the preferential use of bivalent COVID-19 vaccines for primary vaccination of people aged 12 years or older
30 May 2023 - ATAGI has made recommendations on the use of bivalent COVID-19 vaccines as a primary course. ...
Posted by Michael Wonder on 30 May 2023
Novavax's Nuvaxovid receives positive CHMP opinion for full marketing authorisation for the prevention of COVID in the EU
26 May 2023 - Novavax today announced that Nuvaxovid (NVX-CoV2373) has been recommended for full marketing authorisation for use as ...
Posted by Michael Wonder on 29 May 2023
Consultation for various vaccine supply agreements
29 May 2023 - PHARMAC is consulting on potential new supply agreements for multiple vaccines listed in the National Immunisation Schedule. ...