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 25 Jul 2022
Applications for proposed first of a kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA
25 July 2022 - Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple ...
Posted by Michael Wonder on 25 Jul 2022
FDA describes plans to expand remote regulatory assessments
22 July 2022 - The US FDA released draft guidance on Friday that formalises its plans for using remote regulatory assessments ...
Posted by Michael Wonder on 25 Jul 2022
Importing medicines from overseas: guidance needed
25 July 2022 - If a doctor is aware that an expensive medicine their patient desperately needs is available from a ...
Posted by Michael Wonder on 25 Jul 2022
Aurinia announces positive CHMP opinion for Lupkynis (voclosporin) for the treatment of adults with active lupus nephritis in Europe
22 July 2022 - Positive CHMP opinion is based on a comprehensive submission including data from the pivotal AURORA efficacy study ...
Posted by Michael Wonder on 24 Jul 2022
Rhythm Pharmaceuticals receives positive CHMP opinion for Imcivree (setmelanotide) for the treatment of obesity and control of hunger in patients with Bardet-Biedl syndrome
European Commission decision anticipated in fourth quarter of 2022. ...
Posted by Michael Wonder on 24 Jul 2022
Calls for PHARMAC to fund more effective shingles vaccine with cases expected to rise due to COVID-19
24 July 2022 - There are calls from medical experts for PHARMAC to fund a more effective vaccine for shingles, ...
Posted by Michael Wonder on 24 Jul 2022
New campaign to promote COVID-19 oral antiviral treatments
22 July 2022 - The Australian Government today launched a new advertising campaign to encourage eligible Australians to access life-saving COVID-19 ...
Posted by Michael Wonder on 24 Jul 2022
CHMP recommends EU approval of Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
22 July 2022 - The CHMP recommendation is based on results across four Phase 3 studies: TENAYA and LUCERNE in neovascular age-related ...
Posted by Michael Wonder on 23 Jul 2022
CHMP adopts positive opinion recommending Veklury (remdesivir) receive full marketing authorisation for the treatment of patients with COVID-19
22 July 2022 - If Granted by the European Commission, Veklury will become the only direct-acting antiviral with full marketing authorisation ...
Posted by Michael Wonder on 23 Jul 2022
EMA CHMP recommends use of the Moderna COVID-19 booster in adolescents (12-17 Years) in the European Union
22 July 2022 - Moderna today announced that the EMA's CHMP has adopted a positive opinion recommending a variation to ...
Posted by Michael Wonder on 23 Jul 2022
European Union regulation of health technology assessment: what is required for it to succeed?
22 July 2022 - After considerable discussion and debate, the European Commission proposal for the regulation of health technology assessment was ...
Posted by Michael Wonder on 23 Jul 2022
Kite’s CAR T-cell therapy Tecartus receives positive CHMP opinion in relapsed or refractory acute lymphoblastic leukaemia
22 July 2022 - Tecartus (brexucabtagene autoleucel) first and only CAR T in Europe to receive positive CHMP opinion to ...
Posted by Michael Wonder on 23 Jul 2022
Vertex advances VX-548 in acute and neuropathic pain
22 July 2022 - Breakthrough therapy designation granted by FDA. ...
Posted by Michael Wonder on 23 Jul 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for LAG-3-blocking antibody combination Opdualag (nivolumab and relatlimab) for treatment of patients with unresectable or metastatic melanoma
22 July 2022 - Recommendation based on results from the Phase 2/3 RELATIVITY-047 trial, in which the fixed-dose combination of the ...
Posted by Michael Wonder on 23 Jul 2022
Alnylam receives positive CHMP opinion for vutrisiran for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy
22 July 2022 - Positive opinion based on HELIOS-A Phase 3 study. ...