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 Mar 2021
ICER publishes evidence report on therapies for lupus nephritis
12 March 2021 - The evidence suggests belimumab and voclosporin represent important new treatment options for lupus nephritis; there is ...
Posted by Michael Wonder on 13 Mar 2021
COVID-19 vaccines - safety and effectiveness in older adults
10 March 2021 - Data on real-world use of COVID-19 vaccines approved in Australia provides reassurance about their safety in ...
Posted by Michael Wonder on 11 Mar 2021
The broader societal impacts of COVID-19 and the growing importance of capturing these in health economic analyses
9 March 2021 - The rapid spread of the current COVID-19 pandemic has affected societies worldwide, leading to excess mortality, long ...
Posted by Michael Wonder on 11 Mar 2021
Revolutionary option for medical device sterilisation approved by FDA
11 March 2021 - The United States FDA newly approved chlorine dioxide gas for contract sterilisation of medical devices. ...
Posted by Michael Wonder on 11 Mar 2021
COVID-19 vaccine AstraZeneca: PRAC investigating cases of thromboembolic events - vaccine’s benefits currently still outweigh risks
11 March 2021 - The EMA is aware that the Danish Health Authority has paused its vaccination campaign with COVID-19 ...
Posted by Michael Wonder on 11 Mar 2021
Achievements and challenges of the Sakigake designation system in Japan
10 March 2021 - The Sakigake designation system (the Sakigake) has been launched to encourage the pioneered development of innovative new ...
Posted by Michael Wonder on 11 Mar 2021
MHRA authorises Lilly’s RET inhibitor Retsevmo
11 March 2021 - The UK MHRA has granted Eli Lilly’s Retsevmo a conditional marketing authorisation for the treatment of ...
Posted by Michael Wonder on 11 Mar 2021
Dose of reality on vaccination target
12 March 2021 - A 3.1 million dose shortfall in vaccine supplies and a revolt from doctors over inoculation payments ...
Posted by Michael Wonder on 11 Mar 2021
Berlin Heals receives breakthrough device designation from FDA for its C-MIC heart failure device and initiates early feasibility study in the United States
11 March 2021 - Berlin Heals announced today that the US FDA has granted a breakthrough device designation for its ...
Posted by Michael Wonder on 11 Mar 2021
Denali Therapeutics announces fast track designation granted by the U.S. FDA to ETV:IDS (DNL310) for the treatment of patients with Hunter syndrome
11 March 2021 - Denali Therapeutics today announced that the U.S. FDA has granted fast track designation to ETV:IDS (DNL310) for ...
Posted by Michael Wonder on 11 Mar 2021
EMA recommends COVID-19 vaccine Janssen for authorisation in the EU
11 March 2021 - EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Janssen to prevent COVID-19 in ...
Posted by Michael Wonder on 11 Mar 2021
FDA grants fast track designation to Spectrum Pharmaceuticals’ poziotinib
11 March 2021 - Spectrum Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for poziotinib for the ...
Posted by Michael Wonder on 11 Mar 2021
EMA starts rolling review of Eli Lilly antibodies bamlanivimab and etesemivab for COVID-19
11 March 2021 - EMA’s CHMP has started a ‘rolling review’ of data on the antibodies bamlanivimab and etesemivab which are ...
Posted by Michael Wonder on 11 Mar 2021
Astellas submits new drug application for enfortumab vedotin in Japan
11 March 2021 - Enfortumab vedotin to be reviewed by Ministry of Health, Labour and Welfare for patients with locally ...
Posted by Michael Wonder on 11 Mar 2021
Medicare’s new device coverage pathway — breakthrough or breakdown?
10 March 2021 - CMS recently finalised a rule that could substantially alter Medicare coverage decisions for certain new medical devices. ...