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 18 Aug 2022
Chiesi’s Trimbow recommended for use within NHS Scotland
18 August 2022 - The SMC approval brings much needed boost to asthma sufferers across Scotland. ...
Posted by Michael Wonder on 18 Aug 2022
EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine
18 August 2022 - The EMA’s CHMP has started a review of a conditional marketing authorisation application for Skycovion, a ...
Posted by Michael Wonder on 18 Aug 2022
Restart of National Medicines Policy Review is welcome, but assurances needed over further consultation and feedback processes
18 August 2022 - Medicines Australia welcomes the restart of the National Medicines Policy Review, which was put on hold ...
Posted by Michael Wonder on 18 Aug 2022
Valneva initiates rolling submission of FDA biologics license application for its single shot Chikungunya vaccine candidate
18 August 2022 - Valneva today announces that it has initiated rolling submission of the biologics license application to the ...
Posted by Michael Wonder on 18 Aug 2022
FDA label update reflects Bayer’s commitment to providing options for long-acting contraception
18 August 2022 - FDA approves extension of Mirena (levonorgestrel-releasing intrauterine system) 52 mg intrauterine device for up to eight years ...
Posted by Michael Wonder on 18 Aug 2022
Lenvatinib with pembrolizumab for untreated advanced renal cell carcinoma
18 August 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 18 Aug 2022
U.S. FDA accepts Astellas' new drug application for fezolinetant
18 August 2022 - If approved by the FDA, fezolinetant would be a non-hormonal treatment for moderate to severe vasomotor ...
Posted by Michael Wonder on 18 Aug 2022
PHARMAC makes cancer treatment available to more people
18 August 2022 - PHARMAC has confirmed today they are widening access from 1 September 2022 to a targeted cancer treatment, ...
Posted by Michael Wonder on 17 Aug 2022
Early phase oncology trials: why so many designs?
12 August 2022 - The past 30 years have seen a considerable effort on the part of statisticians to improve the ...
Posted by Michael Wonder on 17 Aug 2022
IQWiG annual report for 2021 is available
17 August 2022 - The IQWiG has published its 2021 annual report today. ...
Posted by Michael Wonder on 17 Aug 2022
bluebird bio announces U.S. commercial infrastructure to enable patient access to Zynteglo, the first and only FDA approved gene therapy for people with beta thalassaemia who require regular red blood cell transfusions
17 August 2022 - Innovative outcomes-based contract offering includes single upfront payment and up to 80% risk-sharing. ...
Posted by Michael Wonder on 17 Aug 2022
Accelerated approval of cancer drugs: no economic reward for drug makers that conduct confirmatory trials
17 August 2022 - The FDA uses expedited approval of drugs to speed the development and assessment of drugs that address ...
Posted by Michael Wonder on 17 Aug 2022
FDA approves first cell based gene therapy to treat adult and paediatric patients with beta thalassaemia who require regular blood transfusions
17 August 2022 - Today, the US FDA approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of ...
Posted by Michael Wonder on 17 Aug 2022
Fears for patient safety with hundreds of medicines in short supply
17 August 2022 - Doctors and pharmacists are warning there could be serious consequences for patients if the shortage of hundreds ...
Posted by Michael Wonder on 17 Aug 2022
Samsung Bioepis and Organon announce FDA approval of citrate free high concentration Humira biosimilar Hadlima (adalimumab-bwwd)
17 August 2022 - Samsung Bioepis and Organon today announced the U.S. FDA has approved the citrate free, high concentration (100 ...