Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 02 Nov 2021
Novavax files for COVID-19 vaccine authorisation with Health Canada and completes submission for rolling review to European Medicines Agency
1 November 2021 - Submission of all modules required for regulatory review, including CMC and clinical data, are now complete ...
Posted by Michael Wonder on 02 Nov 2021
Moderna provides update on timing of U.S. emergency use authorisation of its COVID-19 vaccine for adolescents
31 October 2021 - Moderna today provided an update that the U.S. FDA has notified the Company that it will ...
Posted by Michael Wonder on 02 Nov 2021
Junshi Biosciences and Coherus announce FDA acceptance of BLA filing for toripalimab for treatment of nasopharyngeal carcinoma
1 November 2021 - FDA has granted the toripalimab BLA Priority Review with a target action date of April 2022. ...
Posted by Michael Wonder on 02 Nov 2021
ANI Pharmaceuticals announces FDA approval of purified cortrophin gel for multiple indications including multiple sclerosis, rheumatoid arthritis and nephrotic syndrome
1 November 2021 - Approval re-introduces much needed patient and physician choice into the U.S. repository corticotropin market. ...
Posted by Michael Wonder on 02 Nov 2021
Janssen announces extension of U.S. FDA BLA PDUFA date for BCMA CAR-T ciltacabtagene autoleucel
1 November 2021 - Janssen announced today the U.S. FDA has extended the Prescription Drug User Fee Act date to ...
Posted by Michael Wonder on 02 Nov 2021
Incyte announces acceptance of NDA for parsaclisib for three types of relapsed or refractory non-Hodgkin lymphomas
1 November 2021 - Priority review granted to NDA for relapsed or refractory marginal zone lymphoma and mantle cell lymphoma. ...
Posted by Michael Wonder on 02 Nov 2021
Medicare to fund allied health case conferencing
1 November 2021 - New Medicare items will encourage eligible health providers to work together more closely to support the health ...
Posted by Michael Wonder on 01 Nov 2021
TGA recognises two more COVID-19 vaccines not registered in Australia but used widely internationally
1 November 2021 - Today, the TGA determined that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) ...
Posted by Michael Wonder on 01 Nov 2021
Australia to subsidise multiple myeloma drug Darzalex under PBS
31 October 2021 - Blood cancer patients will be among those to benefit with better access to medicine under the Pharmaceutical ...
Posted by Michael Wonder on 31 Oct 2021
Prostate cancer treatment to be put on PBS
31 October 2021 - For the first time in seven years, a prostate cancer therapy will be added to the ...
Posted by Michael Wonder on 31 Oct 2021
Schedule of Pharmaceutical Benefits - 1 November 2021 update
1 November 2021 - The November 2021 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 Oct 2021
Section 19A medicines subsidised by the Pharmaceutical Benefits Scheme
1 November 2021 - In the event of a medicine shortage, a provision under section 19A of the Therapeutic Goods ...
Posted by Michael Wonder on 31 Oct 2021
New Zealand Pharmaceutical Schedule - November 2021 update
1 November 2021 - The November 2021 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 31 Oct 2021
New and amended PBS listings to help thousands of Australians
30 October 2021 - From 1 November 2021, Australians with a respiratory illness, early onset puberty and blood cancer will have ...
Posted by Michael Wonder on 31 Oct 2021
PHARMAC negotiates deal for a further COVID-19 treatment
31 October 2021 - PHARMAC has negotiated an agreement with Roche to purchase another COVID-19 treatment. ...