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 22 Jul 2022
Medicines industry working to minimise medicine supply shortages
22 July 2022 - Medicines Australia and the Generic and Biosimilars Medicines Association are deeply concerned about medicine shortages that ...
Posted by Michael Wonder on 21 Jul 2022
Barriers to accessing life-saving overdose reversal medicine are putting Kiwis at risk - NZ Drug Foundation
21 July 2022 - The lethal drug fentanyl has been found in New Zealand, prompting warnings that the country isn't ...
Posted by Michael Wonder on 21 Jul 2022
Pfizer announces Prevnar 20 (pneumococcal 20 valent conjugate vaccine) is now available in Canada for the prevention of pneumonia and invasive pneumococcal disease in adults 18 years of age and older
21 July 2022 - Prevnar 20 is the first conjugate vaccine indicated to help protect against 20 serotypes responsible for ...
Posted by Michael Wonder on 21 Jul 2022
Karyopharm and Menarini receive full marketing authorisation from the European Commission for Nexpovio (selinexor) for the treatment of patients with multiple myeloma after at least one prior therapy
21 July 2022 - Based on Results from Phase 3 BOSTON Study, Marketing Authorisation Expands Multiple Myeloma Indication. ...
Posted by Michael Wonder on 21 Jul 2022
Aotearoa less affected by medicine supply issues than other countries
22 July 2022 - PHARMAC’s work behind the scenes and unique arrangements with suppliers means New Zealand has been less ...
Posted by Michael Wonder on 21 Jul 2022
Olema Oncology receives FDA fast track designation for OP-1250 for the treatment of ER positive, HER2 negative metastatic breast cancer
21 July 2022 - Olema Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to OP-1250, the ...
Posted by Michael Wonder on 21 Jul 2022
Pliant Therapeutics receives FDA fast track designation for PLN-74809 for the treatment of primary sclerosing cholangitis
21 July 2022 - Pliant Therapeutics announced today that PLN-74809, its oral, dual-selective αvß6/αvß1 integrin inhibitor, has received fast track designation ...
Posted by Michael Wonder on 21 Jul 2022
FDA offers new guidance on therapeutic equivalence evaluations
20 July 2022 - In draft guidance issued on Wednesday, the US FDA explains its approach to therapeutic equivalence evaluations and ...
Posted by Michael Wonder on 21 Jul 2022
Health Canada approves AbbVie's Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis
20 July 2022 - Approval is supported by efficacy and safety data of two pivotal studies in which Rinvoq demonstrated improvements ...
Posted by Michael Wonder on 21 Jul 2022
Ultra-expensive SMA drug Zolgensma to get insurance benefits from August
21 July 2022 - Novartis' Zolgensma (onasemnogene abeparvovec), the world's most expensive drug yet to treat spinal muscular atrophy, will ...
Posted by Michael Wonder on 21 Jul 2022
‘Increasing problem’: Australia facing shortages of more than 320 medicines
21 July 2022 - More than 320 items are becoming hard to find as Australia faces increasing shortages in a crucial ...
Posted by Michael Wonder on 21 Jul 2022
Sandoz supplemental biologics license application accepted by US FDA for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation
21 July 2022 - Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study. ...
Posted by Michael Wonder on 21 Jul 2022
ATAGI update following weekly COVID-19 meeting (20 July 2022)
21 July 2022 - The ATAGI met on 20 July 2022 to consider the latest developments relating to COVID-19 immunisation. ...
Posted by Michael Wonder on 21 Jul 2022
TGA approves Padcev
21 July 2022 - Enfortumab vedotin is an antibody-drug conjugate targeting nectin-4, an adhesion protein located on the surface of epithelial ...
Posted by Michael Wonder on 20 Jul 2022
Simulating colorectal cancer trials using real world data
20 July 2022 - Using real world data –based trial simulation approach, we aim to simulate colorectal cancer trials and ...