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 08 Nov 2021
EMA publishes agenda for 8-11 November CHMP meeting
8 November 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 08 Nov 2021
SMC - November 2021 decisions
8 November 2021 - The Scottish Medicines Consortium which advises on newly licensed medicines for use by NHSScotland has published ...
Posted by Michael Wonder on 08 Nov 2021
Man & Science announces U.S. FDA breakthrough device designation granted for the treatment of chronic cluster headache
8 November 2021 - Man & Science announced today that it has been granted a breakthrough device designation by the Center ...
Posted by Michael Wonder on 08 Nov 2021
Seelos Therapeutics announces FDA grant of fast track designation for SLS-005 (IV trehalose) for the treatment of spinocerebellar ataxia
8 November 2021 - Global Phase IIb/III study for SLS-005 to be initiated in early 2022. ...
Posted by Michael Wonder on 08 Nov 2021
Why does the FDA want to stop improving medicines via patent ‘areas of concern’?
8 November 2021 - It’s hardly unprecedented for one federal agency to encroach on another’s turf. But the latest intra-executive-branch ...
Posted by Michael Wonder on 08 Nov 2021
AZ announces US fast track designation for IL-5 inhibitor Fasenra
8 November 2021 - AstraZeneca’s IL-5 inhibitor Fasenra (benralizumab) has received a fast track designation from the US FDA for ...
Posted by Michael Wonder on 08 Nov 2021
COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir
8 November 2021 - EMA starts review to support possible national decisions on early use. ...
Posted by Michael Wonder on 08 Nov 2021
FDA grants tentative approval for Liquidia’s Yutrepia (treprostinil) inhalation powder
8 November 2021 - Final FDA approval may occur in October 2022 or earlier upon resolution of on-going litigation. ...
Posted by Michael Wonder on 08 Nov 2021
Azurity Pharmaceuticals announces FDA approval of Eprontia (topiramate) oral solution
8 November 2021 - The first and only FDA approved ready to use liquid topiramate. ...
Posted by Michael Wonder on 07 Nov 2021
Start of COVID-19 booster vaccination program
8 November 2021 - Today, the Australian Government’s COVID-19 booster vaccination rollout program officially gets under way, with the initial focus ...
Posted by Michael Wonder on 07 Nov 2021
Biocom California opposes new drug pricing proposal as written
5 November 2021 - Biocom California, the association representing the California life science industry, issued the following statement regarding the ...
Posted by Michael Wonder on 07 Nov 2021
EffRx obtains Swiss marketing authorization for Bronchitol in cystic fibrosis
4 November 2021 - EffRx Pharmaceuticals today announced that Swissmedic has approved Bronchitol (inhaled mannitol) for the treatment of cystic fibrosis ...
Posted by Michael Wonder on 07 Nov 2021
COVID-19: PHARMAC confident with growing stock of drugs to treat virus
7 November 2021 - PHARMAC is growing increasingly confident it is getting close to having enough of the drugs needed to ...
Posted by Michael Wonder on 07 Nov 2021
Cashed up insurers should hand back profits
5 November 2021 - The latest data from the Australian Prudential Regulation Authority highlights the need for insurance companies to ...
Posted by Michael Wonder on 07 Nov 2021
Ocugen announces submission of emergency use authorisation request to the US FDA for investigational COVID-19 vaccine Covaxin (BBV152) for children ages 2-18 years
5 November 2021 - Paediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralising antibody response ...