Blog
RSS FeedPosted by Michael Wonder on 10 Jul 2023
Recommendations made out of session by the PBAC March 2023 and July 2023 meetings – changes to MS-2 Step PBS listing
11 July 2023 - In an out of session consideration, the PBAC has recommended changes to the restriction criteria and eligible ...
Posted by Michael Wonder on 05 Jul 2023
ICER to assess treatment for schizophrenia
5 July 2023 - Report will be subject of New England CEPAC meeting in February 2024; draft scoping document open ...
Posted by Michael Wonder on 05 Jul 2023
European Commission approves Orkambi (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis ages 1 to 2 years old
5 July 2023 - Nearly 300 children with cystic fibrosis and two copies of the F508del mutation are now eligible ...
Posted by Michael Wonder on 29 Jun 2023
Ontario to publicly reimburse Albrioza for the treatment of ALS
28 June 2023 - Ontario lists Albrioza on its drug benefit formulary, becoming the first province to publicly reimburse Albrioza, ...
Posted by Michael Wonder on 29 Jun 2023
Esperion announces submission of application for expanded indication with the EMA for Nilemdo (bempedoic acid) tablet and Nustendi (bempedoic acid and ezetimibe) tablet
28 June 2023 - Seeking inclusion of CV risk reduction indications in Europe. ...
Posted by Michael Wonder on 27 Jun 2023
Allecra Therapeutics submits new drug application to the US FDA for Exblifep for the treatment of complicated urinary tract infections
27 June 2023 - Allecra Therapeutics announced today the submission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 27 Jun 2023
Xigduo XR approved in China for adults with type 2 diabetes
27 June 2023 - Approval makes Xigduo XR the only once daily fixed-dose combination of an SGLT2 inhibitor and metformin ...
Posted by Michael Wonder on 27 Jun 2023
Janssen submits marketing authorisation application to the EMA seeking approval of single tablet combination therapy of macitentan and tadalafil for treatment of patients with pulmonary arterial hypertension
26 June 2023 - This is the first and only single tablet combination therapy to be submitted for review in Europe ...
Posted by Michael Wonder on 24 Jun 2023
Amylyx Pharmaceuticals receives CHMP negative opinion on its conditional marketing authorisation application for AMX0035 for the treatment of ALS in the European Union
23 June 2023 - Amylyx will seek re-examination of its conditional marketing authorisation application. ...
Posted by Michael Wonder on 19 Jun 2023
SMC publishes a Collaborative Advice Document for tixagevimab-cilgavimab (Evusheld) for prevention of COVID-19
14 June 2023 - SMC has collaborated with NICE on Technology Appraisal, TA900: tixagevimab-cilgavimab for preventing COVID-19. ...
Posted by Michael Wonder on 15 Jun 2023
Amylyx Pharmaceuticals completes negotiation process and signs letter of intent with the pCPA for Albrioza for the treatment of ALS
15 June 2023 - Amylyx will now work with federal, provincial, and territorial drug plans to ensure public coverage is available ...
Posted by Michael Wonder on 15 Jun 2023
Health Canada authorises Akeega (niraparib and abiraterone acetate) dual action tablets for targeted treatment of patients with metastatic castration-resistant prostate cancer with BRCA (1/2) gene mutations
14 June 2023 - Approval for Akeega is based on results from the Phase 3 MAGNITUDE study, a prospectively designed precision ...
Posted by Michael Wonder on 02 Jun 2023
Foslevodopa-foscarbidopa for treating Parkinson’s disease with motor symptoms
31 May 2023 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 30 May 2023
Janssen submits new drug application to US FDA seeking approval of investigational single tablet combination therapy of macitentan and tadalafil for treatment of patients with pulmonary arterial hypertension
30 May 2023 - This is the first and only single tablet combination therapy application to be submitted for review in ...
Posted by Michael Wonder on 25 May 2023
FDA approves first oral anti-viral for treatment of COVID-19 in adults
25 May 2023 - Today, the US FDA approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral ...