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 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Outdated criteria for drug plan reimbursement obstruct evidence based care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 ...
Posted by Michael Wonder on 12 Oct 2021
GenSight Biologics announces FDA grant of fast track designation for optogenetic therapy GS030 as treatment for retinitis pigmentosa
12 October 2021 - GenSight Biologics today announced that the U.S. FDA has granted fast track designation to GS030, which combines ...
Posted by Michael Wonder on 12 Oct 2021
Quanterix granted breakthrough device designation from U.S. FDA for blood based pTau 181 assay for Alzheimer’s disease
11 October 2021 - Quanterix Corporation announced today that its Simoa phospho-Tau 181 (pTau-181) blood test has been granted breakthrough ...
Posted by Michael Wonder on 12 Oct 2021
SMC - October 2021 decisions
11 October 2021 - The Scottish Medicines Consortium, which advises on newly licensed medicines for use by NHSScotland has today ...
Posted by Michael Wonder on 11 Oct 2021
Paying for cancer drugs that prove their benefit
11 October 2021 - The United States pays prices for brand name drugs that are estimated to be 256% higher than ...
Posted by Michael Wonder on 11 Oct 2021
Health economic assessment of Poteligeo in the treatment of mycosis fungoides or Sézary syndrome
11 October 2021 - TLV has produced a health economic assessment for the regions for the drug Poteligeo (mogamulizumab). ...
Posted by Michael Wonder on 11 Oct 2021
Merck and Ridgeback announce submission of emergency use authorisation application to the U.S. FDA for molnupiravir, an investigational oral anti-viral medicine, for the treatment of mild to moderate COVID-19 in at risk adults
11 October 2021 - Submissions to regulatory agencies worldwide underway. ...