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 01 Nov 2022
1 November 2022 updates as part of the digital transformation of Authority Required (Written) PBS listings
1 November 2022 - From 1 November 2022, the PBS listings for certain medicines will be updated as part of the ...
Posted by Michael Wonder on 31 Oct 2022
Expanded access to COVID-19 oral antiviral treatments on the PBS
1 November 2022 - Expanded eligibility criteria for COVID-19 oral anti-viral treatments (Lagevrio (molnupiravir) and Paxlovid (nirmatrelvir and ritonavir) ...
Posted by Michael Wonder on 31 Oct 2022
FDA accepts for priority review Ascendis Pharma’s NDA for TransCon PTH in adult patients with hypoparathyroidism
31 October 2022 - PDUFA target action date is 30 April 2023. ...
Posted by Michael Wonder on 31 Oct 2022
New Zealand Pharmaceutical Schedule - 1 November 2022
1 November 2022 - The November 2022 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 31 Oct 2022
Department of Health tweaks the agenda for this week's PBAC meeting
28 October 2022 - The is one late change to the agenda for the November meeting. ...
Posted by Michael Wonder on 30 Oct 2022
CytoDyn announces voluntary withdrawal of BLA for HIV-MDR due to CRO data management issues
28 October 2022 - Company to complete and submit responses to FDA clinical hold. ...
Posted by Michael Wonder on 30 Oct 2022
Another example of a “Shkrelian” drug price increase
28 October 2022 - The story of Martin Shkreli and the drug, Daraprim, has been used as an example of drug ...
Posted by Michael Wonder on 30 Oct 2022
Pharming announces EMA validates its marketing authorisation application under accelerated assessment for leniolisib
28 October 2022 - Marketing authorisation in the European Economic Area anticipated in H1 2023 ...
Posted by Michael Wonder on 29 Oct 2022
Almirall announces EMA acceptance for filing of marketing authorisation application for lebrikizumab in atopic dermatitis
28 October 2022 - The EMA application is based on the analysis of Phase 3 studies ADvocate 1&2 and ADhere. ...
Posted by Michael Wonder on 29 Oct 2022
Actemra IV (tocilizumab for injection) receives authorisation for additional indication from Health Canada for the treatment of COVID-19
28 October 2022 - Actemra is shown to improve outcomes including mortality in patients hospitalised with COVID-19 requiring supplemental oxygen. ...
Posted by Michael Wonder on 28 Oct 2022
US FDA defers action on filing for AT-GAA in late-onset Pompe disease
28 October 2022 - FDA issues deferred action letter on AT-GAA regulatory filing due to the inability to conduct required manufacturing ...
Posted by Michael Wonder on 28 Oct 2022
EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
28 October 2022 - EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated ...
Posted by Michael Wonder on 28 Oct 2022
Outlook Therapeutics announces acceptance of biologics license application by U.S. FDA for ONS-5010 as a treatment for wet AMD
28 October 2022 - Prescription Drug User Fee Act goal date of 29 August 2023. ...
Posted by Michael Wonder on 28 Oct 2022
AbbVie announces submissions of regulatory applications for epcoritamab (DuoBody-CD3xCD20) for the treatment of relapsed/refractory diffuse large B-cell lymphoma and large B-cell lymphoma
28 October 2022 - EMA validates AbbVie's marketing authorisation application; Genmab submits biologics license application to US FDA. ...
Posted by Michael Wonder on 28 Oct 2022
European Medicines Agency validates ViiV Healthcare’s marketing authorisation application for cabotegravir long-acting injectable for HIV prevention
28 October 2022 - The marketing application is based on results from the HPTN 083 and 084 Phase 2b/3 studies ...