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 02 Feb 2022
Register study on gene therapy with Zolgensma starts
1 February 2022 - Experience from clinical practice with Zolgensma, a gene therapy against certain forms of spinal muscular atrophy in ...
Posted by Michael Wonder on 02 Feb 2022
ABPI analysis on NICE’s changes for evaluating new medicines: next steps
31 January 2022 - NICE has published a new Manual, which sets out how the latest medicines and health technologies ...
Posted by Michael Wonder on 02 Feb 2022
New EU regulation on health technology assessment of cancer medicines
1 February 2022 - On Dec 15, 2021, the EU adopted a new regulation to harmonise health technology assessment of new ...
Posted by Michael Wonder on 02 Feb 2022
Global consequences of the US FDA's accelerated approval of cancer drugs
1 February 2022 - The accelerated approval system is a fast track drug approval pathway created by the US FDA in ...
Posted by Michael Wonder on 02 Feb 2022
Review of the National Medicines Policy – consultation on the draft closes 16 February 2022
2 February 2022 - Since August 2021, the Committee has heard from nearly 200 stakeholders through bilateral interviews and virtual group ...
Posted by Michael Wonder on 02 Feb 2022
Equity in cancer drug access in the UK
1 February 2022 - In draft guidance published on 5 January 2022, NICE announced their decision not to recommend the use ...
Posted by Michael Wonder on 02 Feb 2022
Universal health care bill fails to pass in California
1 February 2022 - A bill that would have created the nation's only universal health care system has failed to pass ...
Posted by Michael Wonder on 01 Feb 2022
Pfizer and BioNTech initiate rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age following request from U.S. FDA
1 February 2022 - Companies plan to submit additional data on a third 3 µg dose in this age group in ...
Posted by Michael Wonder on 01 Feb 2022
Aussie device that gives eyes to the blind fast tracked in US
1 February 2022 - A world-first bionic eye that restores partial vision to the blind has been given “breakthrough” designation ...
Posted by Michael Wonder on 01 Feb 2022
Veru announces FDA grant of fast track designation for sabizabulin for the treatment of hospitalised COVID-19 patients at high risk for acute respiratory distress syndrome
31 January 2022 - Second Veru drug under development to receive FDA fast track designation this month. ...
Posted by Michael Wonder on 01 Feb 2022
U.S. FDA approves new label update for CAR T-cell therapy Yescarta showing prophylactic steroid use improves management of cytokine release syndrome
31 January 2022 - Updated toxicity management strategy can improve certain adverse events without compromising the activity of Yescarta. ...
Posted by Michael Wonder on 01 Feb 2022
Blue Note Therapeutics receives breakthrough device designation for prescription only digital therapeutic for acute myeloid leukaemia
31 January 2022 - Blue Note Therapeutics, a prescription digital therapeutics company dedicated to easing the burden of cancer and improving ...
Posted by Michael Wonder on 01 Feb 2022
ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for use every two months, expanding the label of the first and only complete long-acting HIV treatment
1 February 2022 - Cabenuva is now approved for administration as few as six times a year for virologically suppressed ...
Posted by Michael Wonder on 01 Feb 2022
Byannli authorised in Britain for schizophrenia treatment
1 February 2022 - Market authorisation for twice yearly schizophrenia treatment which offers patients much-needed medication continuity ...
Posted by Michael Wonder on 01 Feb 2022
FDA approves prophylactic treatment with Vonvendi [von Willebrand factor (recombinant)] for adult patients living with severe type 3 von Willebrand disease
31 January 2022 - Vonvendi [von Willebrand factor (recombinant)] is the first and only treatment approved for routine prophylaxis to reduce ...