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 05 Jan 2021
Daiichi Sankyo submits application for oncolytic virus teserpaturev (G47∆) for treatment of patients with malignant glioma in Japan
5 January 2020 - Daiichi Sankyo and the University of Tokyo are collaboratively developing teserpaturev, which has received SAKIGAKE designation and ...
Posted by Michael Wonder on 05 Jan 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for resected oesophageal or gastro-oesophageal junction cancer following chemoradiotherapy
4 January 2021 - Bristol Myers Squibb today announced that the EMA validated its marketing authorisation application for Opdivo (nivolumab) ...
Posted by Michael Wonder on 04 Jan 2021
Ibrutinib with rituximab in previously untreated chronic lymphocytic leukaemia: indication of added benefit over FCR
4 January 2020 - The new drug combination prolongs overall survival in patients in good general health. No study data are ...
Posted by Michael Wonder on 04 Jan 2021
FDA grants ARX788 fast track designation for HER2 positive metastatic breast cancer
4 January 2021 - Ambrx announced that the U.S. FDA granted ARX788 fast track designation as monotherapy for the treatment of ...
Posted by Michael Wonder on 04 Jan 2021
Provention Bio announces U.S. FDA filing of a biologics license application and priority review for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk Individuals
4 January 2020 - FDA sets PDUFA goal date of 2 July 2021. ...
Posted by Michael Wonder on 04 Jan 2021
US FDA accepts regulatory submission from Pfizer and OPKO for review of somatrogon to treat pediatric patients with growth hormone deficiency
4 January 2020 - If approved, somatrogon will serve as a once-weekly treatment option. ...
Posted by Michael Wonder on 04 Jan 2021
NICE collaboration on streamlined licensing and patient access process for new medicines opened on January 1st
4 January 2020 - Companies can now submit medicines for the new Innovative Licensing and Access Pathway following close collaboration between ...
Posted by Michael Wonder on 04 Jan 2021
TGA still waiting for 'further data' on AstraZeneca vaccine
4 January 2020 - Concerns over new coronavirus cases in Sydney and Melbourne look unlikely to prompt an accelerated approval ...
Posted by Michael Wonder on 04 Jan 2021
ALS patients and advocates say Canada needs better access to new treatments
3 January 2020 - 'The clock is ticking for us,' says a Niagara man who has ALS, and has joined the ...
Posted by Michael Wonder on 01 Jan 2021
New Zealand Pharmaceutical Schedule - 1 January 2021
1 January 2021 - The January 2021 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 01 Jan 2021
Schedule of Pharmaceutical Benefits - 1 January 2021 update
1 January 2021 - The January 2021 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 01 Jan 2021
CytRx issues statement regarding U.S. regulatory review of arimoclomol for Niemann-Pick disease type C
31 December 2020 - CytRx today provided an update on the U.S. FDA review of Orphazyme new drug application for arimoclomol ...
Posted by Michael Wonder on 31 Dec 2020
Tetra Bio-Pharma files new drug submission for Reduvo in Canada
30 December 2020 - The addressable market is estimated to be $80 million CDN by 2022. ...
Posted by Michael Wonder on 31 Dec 2020
Britain approves AstraZeneca’s COVID-19 jab
30 December 2020 - It is cheaper, easier to distribute and more plentiful than rival vaccines. India is watching closely. ...
Posted by Michael Wonder on 30 Dec 2020
Update on rolling review of AstraZeneca’s COVID-19 vaccine
30 December 2020 - EMA’s assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing ...