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 Jul 2021
Calls grow for an investigation into FDA approval of Biogen’s Alzheimer’s drug
30 June 2021 - Former health secretary Donna Shalala called for a federal investigation into the FDA’s polarising approval of ...
Posted by Michael Wonder on 01 Jul 2021
FoundationOne CDx receives FDA approval as a companion diagnostic for Alunbrig (brigatinib) to identify patients with ALK positive metastatic non-small cell lung cancer
1 July 2021 - Foundation Medicine today announced that it has received approval from the U.S. FDA for FoundationOne CDx to ...
Posted by Michael Wonder on 01 Jul 2021
FDA approves supplemental new drug application for Adhansia XR (methylphenidate hydrochloride) extended release capsules
1 June 2021 - Phase 3 adult laboratory classroom study confirmed that Adhansia XR provided rapid and sustained symptom relief ...
Posted by Michael Wonder on 01 Jul 2021
FDA approves dose escalation label update for Puma Biotechnology’s Nerlynx (neratinib) in HER2 positive early stage and metastatic breast cancer
1 June 2021 - Dose escalation of Nerlynx therapy demonstrated improved management and prevention of Grade 3 diarrhoea. ...
Posted by Michael Wonder on 01 Jul 2021
FDA approves component of treatment regimen for most common childhood cancer
30 June 2021 - Today, the U.S. FDA approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen ...
Posted by Michael Wonder on 01 Jul 2021
LEXEO Therapeutics receives rare paediatric disease designation and orphan drug designation for LX2006 for the treatment of Friedreich’s ataxia
30 June 2021 - Phase I/II clinical trial in patients with cardiomyopathy associated with Friedreich’s ataxia expected to initiate in 2021. ...
Posted by Michael Wonder on 01 Jul 2021
Neuroelectrics granted FDA breakthrough device designation for new therapeutic neuromodulation platform to treat refractory focal epilepsy
30 June 2021 - In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44% median ...
Posted by Michael Wonder on 01 Jul 2021
U.S. FDA accepts filing of Hutchmed's NDA for surufatinib for the treatment of advanced neuroendocrine tumours
1 July 2021 - U.S. FDA has assigned a target action date of 30 April 2022. ...
Posted by Michael Wonder on 01 Jul 2021
Additional treatment option – Tremfya – now available on the PBS for Australians with active psoriatic arthritis
1 July 2021 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that Tremfya (guselkumab) is now available on ...
Posted by Michael Wonder on 01 Jul 2021
PHARMAC is seeking views on declining funding applications
29 June 2021 - PHARMAC is considering declining 97 inactive medicine funding applications. ...
Posted by Michael Wonder on 01 Jul 2021
Guaranteeing Medicare
1 July 2021 - The Australian Government is investing record funding in Medicare, providing more support to Australians as we face ...
Posted by Michael Wonder on 01 Jul 2021
COVID-19 vaccine weekly safety report (1 July 2021)
1 July 2021 - Five additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 30 Jun 2021
Will Biogen’s new Alzheimer’s drug’s burden on Medicare be big, huge, or catastrophic?
28 June 2021 - The FDA’s decision to grant wide-ranging approval to the controversial, pricey new Alzheimer’s drug Aduhelm will ...
Posted by Michael Wonder on 30 Jun 2021
ICER to assess treatment for type 2 diabetes
30 June 2021 - Report will be subject of New England CEPAC meeting in January 2022; draft scoping document open ...
Posted by Michael Wonder on 30 Jun 2021
New Zealand Pharmaceutical Schedule - 1 July 2021 update
1 July 2021 - The July 2021 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...