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 27 Mar 2023
TGA’s new powers will help reduce the impact of medicine shortages on patients
24 March 2023 - From 22 March 2023, the TGA can approve the temporary import or supply of an overseas approved ...
Posted by Michael Wonder on 27 Mar 2023
COVID-19 vaccine safety report (23 March 2023)
23 March 2023 - To 19 March 2023, more than 44 million doses have been administered in Australia, as well ...
Posted by Michael Wonder on 27 Mar 2023
Health Canada authorises Imbruvica (ibrutinib) in a fixed duration combination with venetoclax for adult patients with previously untreated chronic lymphocytic leukaemia
23 March 2023 - All oral, once daily, fixed duration combination regimen authorised for first-line treatment of CLL. ...
Posted by Michael Wonder on 27 Mar 2023
Columvi (glofitamab for injection) receives Health Canada authorisation with conditions for adult patients with relapsed or refractory diffuse large B-cell lymphoma
25 March 2023 - Authorization is based on results from the Phase 1/2 NP30179 study, which demonstrated Columvi induced durable response ...
Posted by Michael Wonder on 27 Mar 2023
Health Canada approves first treatment option for generalised pustular psoriasis flares in adults
24 March 2023 - In the EFFISAYIL-1 trial, over half of the Spevigo (spesolimab) treated patients were free of pustules, ...
Posted by Michael Wonder on 25 Mar 2023
TLV is preparing for an increase in ceiling prices
17 March 2023 - In order to ensure continued good access to medicines for patients, TLV started in the autumn of ...
Posted by Michael Wonder on 25 Mar 2023
MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years
21 March 2023 - The legislative changes will help to make the UK one of the best countries in the world ...
Posted by Michael Wonder on 25 Mar 2023
Incyte provides regulatory update on ruxolitinib extended release tablets
23 March 2023 - Incyte today announced that the US FDA has issued a complete response letter for ruxolitinib extended ...
Posted by Michael Wonder on 25 Mar 2023
FDA approves first treatment for activated phosphoinositide 3-kinase delta syndrome
24 March 2023 - The FDA has approved Joenja (leniolisib) tablets as the first treatment for activated phosphoinositide 3-kinase delta ...
Posted by Michael Wonder on 25 Mar 2023
NICE recommends life-changing gene therapy for children with ultra rare genetic disorder in final draft guidance
23 March 2023 - The first and currently only gene therapy for children with an ultra-rare genetic disorder has been recommended ...
Posted by Michael Wonder on 25 Mar 2023
Lapse of provisional registration for Tecentriq (atezolizumab) for the treatment of locally advanced or metastatic triple negative breast cancer
22 March 2023 - On 22 March 2023, the provisional registration of Tecentriq (atezolizumab) for the treatment of mTNBC will ...
Posted by Michael Wonder on 23 Mar 2023
Calquence granted first regulatory approval in China for adults with previously treated mantle cell lymphoma
23 March 2023 - Across two clinical trials 82% overall response and 35% complete response rate were observed in Chinese ...
Posted by Michael Wonder on 23 Mar 2023
Drug makers push back on a clever tactic employers use to avoid paying for specialty medicines
22 March 2023 - In the face of rising drug prices, health plan sponsors have quietly used a clever, but ...
Posted by Michael Wonder on 23 Mar 2023
Cidara Therapeutics and Melinta Therapeutics announce FDA approval of Rezzayo (rezafungin for injection) for the treatment of candidemia and invasive candidiasis
22 March 2023 - Rezzayo is the first new FDA approved echinocandin in over a decade. ...
Posted by Michael Wonder on 23 Mar 2023
Investments to support access to drugs for rare diseases
22 March 2023 - Today, the Government announced a total investment of up to $1.5 billion over three years in ...