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 Mar 2022
Scottish Medicines Consortium update
7 March 2022 - Diurnal provides an update on the status of reimbursement of Efmody (modified release hydrocortisone) for NHS ...
Posted by Michael Wonder on 07 Mar 2022
TGA approves Sogroya
8 March 2022 - Somapacitan is a long‑acting recombinant human growth hormone derivative. ...
Posted by Michael Wonder on 07 Mar 2022
PHARMAC proposes widened access to the flu vaccine for Māori and Pacific peoples for 2022 season
8 March 2022 - PHARMAC is consulting on a proposal to widen access to the funded influenza vaccine to include Māori ...
Posted by Michael Wonder on 07 Mar 2022
Merit Medical receives FDA breakthrough device designation for Embosphere microspheres for use in genicular artery embolisation for symptomatic knee osteoarthritis
7 March 2022 - Merit Medical Systems announced today that it has received breakthrough device designation from the U.S. FDA ...
Posted by Michael Wonder on 07 Mar 2022
Key Democrat moves to crack down on FDA accelerated approvals
7 March 2022 - A powerful Democratic lawmaker has introduced a bill that would dramatically rein in the Food and ...
Posted by Michael Wonder on 07 Mar 2022
Teva announces launch of a first generic version of Revlimid (lenalidomide capsules) in the U.S.
7 March 2022 - Teva Pharmaceuticals announced today the launch of a first generic version of Revlimid (lenalidomide capsules), in 5 ...
Posted by Michael Wonder on 07 Mar 2022
SMC - March 2022 decisions
7 March 2022 - The Scottish Medicines Consortium, which advises on newly licensed medicines for use by NHSScotland, has today ...
Posted by Michael Wonder on 07 Mar 2022
Novavax’s Covid-19 vaccine moves closer to FDA authorisation decision
6 March 2022 - Company says it has resolved manufacturing problems that led to earlier delays; FDA is reviewing shot’s authorisation ...
Posted by Michael Wonder on 07 Mar 2022
Rezafungin awarded promising innovation medicine designation by the UK’s Medicines and Healthcare Products Regulatory Agency for the treatment of invasive candidiasis
3 March 2022 - Rezafungin is a next-generation once weekly echinocandin being developed for both the treatment and prevention of serious ...
Posted by Michael Wonder on 07 Mar 2022
Horizon Therapeutics announces FDA has granted priority review of the supplemental biologics license application for the concomitant use of Krystexxa (pegloticase injection) plus methotrexate for people living with uncontrolled gout
7 March 2022 - Application based on recent MIRROR randomised controlled trial results, which showed 71% of patients randomised to ...
Posted by Michael Wonder on 07 Mar 2022
Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib tablets) in combination with azacitidine for patients with previously untreated IDH1 mutated acute myeloid leukaemia
7 March 2022 - sNDA based on data from the global, Phase 3, AGILE trial evaluating Tibsovo in combination with ...
Posted by Michael Wonder on 07 Mar 2022
Jardiance (empagliflozin) becomes the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction
7 March 2022 - The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with ...
Posted by Michael Wonder on 07 Mar 2022
Medicare bulk billing rates surge across our health system
6 March 2022 - Essential medical care is more affordable than ever before with the number of Australians receiving essential medical ...
Posted by Michael Wonder on 07 Mar 2022
ATAGI update following weekly COVID-19 meeting (2 March 2022)
7 March 2022 - As of 1 March 2022, over 54 million doses of COVID-19 vaccines have been administered in ...
Posted by Michael Wonder on 06 Mar 2022
Australian COVID nasal spray not on shop shelves amid TGA dispute
4 March 2022 - Melbourne start-up Starpharma is at loggerheads with the medicines regulator over the approvals process for its ...