Blog
RSS FeedPosted by Michael Wonder on 24 Mar 2022
Moderna finalises strategic partnership with Australian Government
23 March 2022 - On-shore manufacturing facility based in Melbourne, Australia, expected to produce up to 100 million mRNA respiratory ...
Posted by Michael Wonder on 24 Mar 2022
TGA approves new medicine for patients with multiple sclerosis
24 March 2022 - Ponesimod is a sphingosine 1 phosphate receptor 1 modulator. ...
Posted by Michael Wonder on 24 Mar 2022
COVID-19 vaccine weekly safety report (24 March 2022)
24 March 2022 - To 20 March 2022, the TGA has received 485 reports which have been assessed as likely to ...
Posted by Michael Wonder on 23 Mar 2022
Novartis Pluvicto approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer
23 March 2022 - FDA also approved complementary diagnostic imaging agent, Locametz, after radiolabeling with gallium-68 for the identification of PSMA ...
Posted by Michael Wonder on 23 Mar 2022
Moderna has initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children 6 to under 12 years of age
23 March 2022 - Moderna today announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna COVID-19 ...
Posted by Michael Wonder on 23 Mar 2022
Orphazyme announces withdrawal of European marketing authorisation application for arimoclomol for the treatment of Niemann-Pick disease type C
22 March 2022 - Decision to withdraw the European marketing authorisation application comes ahead of scheduled final vote on the ...
Posted by Michael Wonder on 23 Mar 2022
StemCyte has submitted its application for a biologics license for its allogeneic umbilical cord haematopoietic progenitor cell product "HPC-Cord Blood", to the US FDA
22 March 2022 - The BLA has been accepted for quality review and StemCyte anticipates licensure in 2023 ...
Posted by Michael Wonder on 23 Mar 2022
MorphoSys and Incyte announce Swissmedic temporary approval of Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with r/r DLBCL
22 March 2022 - Minjuvi is a new therapeutic option for eligible DLBCL patients in Switzerland addressing an urgent unmet medical ...
Posted by Michael Wonder on 23 Mar 2022
Medicago, Philip Morris and Health Canada: a predictable and avoidable fiasco
22 March 2022 - Health groups urge the Federal government to pressure Medicago to align its approach with that of ...
Posted by Michael Wonder on 23 Mar 2022
Instrumental variables and heterogeneous treatment effects
22 March 2022 - A randomised clinical trial can be used to estimate the average treatment effect for a population. ...
Posted by Michael Wonder on 22 Mar 2022
Prescription medicines: new or extended uses, or new combinations of registered medicines (February 2022)
22 March 2022 - The TGA approved a new indication for 7 medicines and one vaccine in February. ...
Posted by Michael Wonder on 22 Mar 2022
Hope for quadriplegics as ‘miracle treatment’ gets green light from regulator
21 March 2022 - In a major step forward for treating victims of paralysis, Australian regenerative medicine company Orthocell has ...
Posted by Michael Wonder on 22 Mar 2022
Ascentage Pharma's MDM2-p53 inhibitor alrizomadlin (APG-115) granted rare paediatric disease designation by the US FDA for the treatment of neuroblastoma
21 March 2022 - Ascentage Pharma today announced that its novel MDM2-p53 inhibitor, alrizomadlin (APG-115), was granted a rare paediatric disease ...
Posted by Michael Wonder on 22 Mar 2022
KYE Pharmaceuticals files Accrufer new drug submission in Canada for the treatment of iron deficiency
21 March 2022 - Shield Therapeutics announces that KYE Pharmaceuticals has submitted a new drug submission to Health Canada for ...
Posted by Michael Wonder on 22 Mar 2022
Travere Therapeutics submits new drug application for sparsentan for the treatment of IgA nephropathy
21 March 2022 - Travere Therapeutics today announced that it has submitted a new drug application to the U.S. FDA ...