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 13 Dec 2021
Janssen EMEA receives conditional marketing authorisation for Rybrevant (amivantamab), the first treatment approved for patients with advanced non-small-cell lung cancer with EGFR exon 20 insertion mutations
10 December 2021 - Janssen EMEA receives conditional marketing authorisation for Rybrevant (amivantamab), the first treatment approved for patients with advanced ...
Posted by Michael Wonder on 12 Dec 2021
Where to now for PHARMAC?
10 December 2021 - The interim report of the review of PHARMAC has just been published, with the thrust of ...
Posted by Michael Wonder on 12 Dec 2021
FDA approves NGS based companion diagnostic for EGFR exon20 insertion mutant non-small-cell lung cancer tumour tissue
9 December 2021 - Oncomine Dx Target Test now approved for 12 NSCLC targeted therapies globally. ...
Posted by Michael Wonder on 12 Dec 2021
Australian Technical Advisory Group on Immunisation recommendations on the use of Spikevax (Moderna) as a COVID-19 booster vaccine
12 December 2021 - Spikevax (Moderna), also referred to as the Moderna COVID-19 vaccine, has been provisionally approved for use as ...
Posted by Michael Wonder on 12 Dec 2021
ATAGI statement on the Omicron variant and timing of COVID-19 booster vaccination
12 December 2021 - The COVID-19 vaccines used in Australia are critical in protecting against COVID-19 due to all variants, including ...
Posted by Michael Wonder on 11 Dec 2021
Junshi Biosciences announces NMPA accepted supplemental new drug application for toripalimab in combination with chemotherapy as first-line treatment of advanced NSCLC
10 December 2021 - Sixth indication for toripalimab submitted in China. ...
Posted by Michael Wonder on 11 Dec 2021
‘All I want for Christmas’ is higher prices: Congressional report accuses pharma of manipulating Americans for profit
10 December 2021 - It was the day before Christmas in 2015 and a senior director of national accounts at ...
Posted by Michael Wonder on 10 Dec 2021
Cytokinetics announces receipt of breakthrough therapy designation from FDA for aficamten
9 December 2021 - FDA granted designation for the treatment of symptomatic obstructive hypertrophic cardiomyopathy Based on results of REDWOOD-HCM. ...
Posted by Michael Wonder on 10 Dec 2021
International regulators stress continued need for COVID-19 therapeutics
11 December 2021 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all ...
Posted by Michael Wonder on 10 Dec 2021
Health Minister Greg Hunt tells health funds to reduce price rises
11 December 2021 - Health funds have been told to reduce the increase on premiums next year, after Health Minister Greg ...
Posted by Michael Wonder on 10 Dec 2021
VBI Vaccines announces filing of new drug submission for 3 antigen hepatitis B vaccine to Health Canada
9 December 2021 - VBI Vaccines today announced the filing of a new drug submission to Health Canada for the Company’s ...
Posted by Michael Wonder on 10 Dec 2021
Price disclosure 2022 April cycle outcomes summary
10 December 2021 - The summary of price disclosure price reductions for the 2022 April Cycle has now been published ...
Posted by Michael Wonder on 10 Dec 2021
Intercept announces withdrawal of EMA marketing authorisation application for obeticholic acid for advanced liver fibrosis due to NASH
9 December 2021 - Intercept Pharmaceuticals today announced that it has formally notified the EMA of its decision to withdraw ...
Posted by Michael Wonder on 09 Dec 2021
Henlius' fourth biologic bevacizumab biosimilar approved by National Medical Products Administration
3 December 2021 - Shanghai Henlius Biotech announced that bevacizumab biosimilar, developed and manufactured by Henlius independently, has been approved by ...
Posted by Michael Wonder on 09 Dec 2021
Legend Biotech announces submission of new drug application to Japanese regulatory authority for BCMA CAR-T therapy cilta-cel for the treatment of relapsed or refractory multiple myeloma by Janssen
7 December 2021 - Submission based on data from pivotal CARTITUDE-1 trial ...