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 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
South Korea approves second COVID-19 pill Lagevrio
23 March 2022 - The South Korean Government has approved the emergency use of anti-COVID-19 pill Lagevrio, the Ministry of ...
Posted by Michael Wonder on 23 Mar 2022
Acceptability of manufacturer proposed utility values for NICE cancer medicine appraisals: analysis of manufacturers’ information sources
21 March 2022 - The NICE method guide for technology appraisals encourages medicine manufacturers to use the EuroQol 5 Dimension in ...
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
Government opts for additional consultation on National Medicines Policy review
24 March 2022 - The Government has heeded the calls from Medicines Australia, patient groups, health bodies, and industry by ...
Posted by Michael Wonder on 23 Mar 2022
The biggest PBMs are handling more and more of the country’s drug price negotiations
22 March 2022 - Alex Schmelzer didn’t think he’d be the most-hated person in drug pricing negotiations, but he was. ...
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
U.S. Senate to vote this spring on lowering insulin prices - Senator Schumer
23 March 2022 - U.S. Senate Majority Leader Chuck Schumer said on Tuesday he intends to hold votes this spring ...
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
Pharmacy benefit managers are the wrong target In Biden’s quest to reduce drug prices
21 March 2022 - Prescription drug prices remain high despite the fact that the Biden Administration—and its predecessors—have declared reducing prices ...