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 Oct 2021
FDA approves abemaciclib with endocrine therapy for early breast cancer
13 October 2021 - On 12 October 2021, the FDA approved abemaciclib (Verzenio, Eli Lilly) with endocrine therapy (tamoxifen or an ...
Posted by Michael Wonder on 13 Oct 2021
MHRA backs Merck’s MET inhibitor Tepmetko
13 October 2021 - The UK MHRA has conditonally authorised Merck’s MET inhibitor Tepmetko (tepotinib) for the treatment of certain ...
Posted by Michael Wonder on 13 Oct 2021
Provisional determination granted to Pfizer's COVID-19 vaccine (Comirnaty) - proposed for use in children 5-11 years of age
13 October 2021 - On 12 October 2021, the Therapeutic Goods Administration granted a provisional determination to Pfizer in relation ...
Posted by Michael Wonder on 12 Oct 2021
European authorities launch HTA network
12 October 2021 - On 29 September, the heads of 19 European HTA authorities met to launch a network for strategic ...
Posted by Michael Wonder on 12 Oct 2021
FDA’s accelerated approval program: is change on the way?
11 October 2021 - The U.S. FDA launched its accelerated approval program in 1992, offering a pathway to bring life saving ...
Posted by Michael Wonder on 12 Oct 2021
When is the Novavax vaccine coming to Australia? Will it be used for booster shots?
13 October 2021 - Australia's vaccination rate is galloping towards 85 per cent, and more than six in 10 Australians ...
Posted by Michael Wonder on 12 Oct 2021
NICE guidance on inclisiran should be reconsidered
12 October 2021 - Recommendation is premature without data on cardiovascular outcomes. ...
Posted by Michael Wonder on 12 Oct 2021
Deciphera announces approval of Qinlock in Switzerland for the treatment of fourth-line gastro-intestinal stromal tumour
12 October 2021 - Seventh approval worldwide for Qinlock and first European approval. ...
Posted by Michael Wonder on 12 Oct 2021
Outdated criteria for drug plan reimbursement obstruct evidence based care
12 October 2021 - An important flaw in the funding approach used by Canada’s public drug plans is highlighted by the ...
Posted by Michael Wonder on 12 Oct 2021
Where is the PHARMAC Review Panel’s interim report?
12 October 2021 - Patient advocacy groups and clinicians are calling out the PHARMAC Review Panel for failing to get their ...
Posted by Michael Wonder on 12 Oct 2021
Vaccinations can end political blame game: CSL
13 October 2021 - CSL chief Paul Perreault has warned that the politicisation of Covid-19 is fuelling vaccination hesitancy as ...
Posted by Michael Wonder on 12 Oct 2021
DoH revises agenda ahead of new month's PBAC meeting
12 October 2021 - One minor change. ...
Posted by Michael Wonder on 12 Oct 2021
EMA publishes agenda for 11-14 October CHMP meeting
11 October 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 12 Oct 2021
Y-mAbs’ 177Lu-omburtamab-DTPA for the treatment of patients with medulloblastoma granted rare paediatric disease designation by FDA
7 October 2021 - Y-mAbs Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for the Company’s ...
Posted by Michael Wonder on 12 Oct 2021
EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac
13 October 2021 - The EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company ...