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 24 Aug 2022
Access criteria for new COVID-19 treatment announced
25 August 2022 - PHARMAC has today confirmed the access criteria for the first preventative medicine for COVID-19, tixagevimab and cilgavimab ...
Posted by Michael Wonder on 24 Aug 2022
How a long-overlooked protein could remake neuroscience drug discovery — or plunge the FDA into controversy
24 August 2022 - So, imagine you get punched in the head. Not once, but a bunch of times. ...
Posted by Michael Wonder on 24 Aug 2022
Avalglucosidase alfa for treating Pompe disease
24 August 2022 - NICE has published evidence-based recommendations on the use of avalglucosidase alfa for the treatment of patients ...
Posted by Michael Wonder on 23 Aug 2022
Moderna completes application to US FDA for emergency use authorisation of omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222
23 August 2022 - Clinical data available for Moderna's bivalent COVID-19 booster vaccines have met all primary endpoints and support ...
Posted by Michael Wonder on 23 Aug 2022
Extra-ordinary meeting of the CHMP: 1 September 2022
23 August 2022 - This extra-ordinary meeting is organised to discuss the evaluation of two applications for adapted mRNA COVID-19 ...
Posted by Michael Wonder on 23 Aug 2022
Pillar Biosciences receives China National Medical Products Administration approval for oncoReveal Dx colon cancer assay
22 August 2022 - Highly accurate, tissue based, next generation sequencing test approved in China as a companion diagnostic for ...
Posted by Michael Wonder on 23 Aug 2022
The EU HTA regulation: a new frontier for access to innovative technologies
23 August 2022 - A new health technology regulation is due to be applied to help EU countries determine the effectiveness ...
Posted by Michael Wonder on 23 Aug 2022
FDA approves Abbott's new spinal cord stimulation device; provides tailored relief to multiple pain areas and adds more treatment options for evolving pain conditions
23 August 2022 - Abbott's new Proclaim Plus spinal cord stimulation system offers the next generation of stimulation therapy, giving physicians ...
Posted by Michael Wonder on 23 Aug 2022
Health Canada approves Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment for adult patients with resectable non-small-cell lung cancer
23 August 2022 - First and only immunotherapy-based treatment for use before surgery for non-small-cell lung cancer in Canada. ...
Posted by Michael Wonder on 23 Aug 2022
Hiring and data: how the US will set up new Medicare drug price talks
23 August 2022 - The US Government will soon begin hiring experts and collecting the data needed to launch direct ...
Posted by Michael Wonder on 23 Aug 2022
AstraZeneca's Soriot warns new US drug price law will hurt innovation
23 August 2022 - AstraZeneca's Chief Executive Pascal Soriot warned on Tuesday new US legislation capping drug prices would reduce ...
Posted by Michael Wonder on 23 Aug 2022
European Medicines Agency commences review of oral fixed-dose combination of decitabine and cedazuridine for the treatment of adults with acute myeloid leukaemia
22 August 2022 - Otsuka and Astex Pharmaceuticals today announce that the EMA has accepted the marketing authorisation application for the ...
Posted by Michael Wonder on 23 Aug 2022
iECURE receives FDA rare paediatric disease designation for GTP-506, an investigational gene editing product candidate for the treatment of ornithine transcarbamylase deficiency
23 August 2022 - GTP-506, a potential single-dose gene editing therapy designed to restore metabolic function in patients suffering with OTC ...
Posted by Michael Wonder on 23 Aug 2022
Synlogic granted FDA fast track designation for SYNB1353 for the treatment of homocystinuria
23 August 2022 - Synlogic today announced that the U.S. FDA has granted fast track designation to SYNB1353 for the potential ...
Posted by Michael Wonder on 23 Aug 2022
Merck receives fast track designation from the US FDA for MK-2060, an investigational anti-coagulant therapy
23 August 2022 - Phase 2 study of MK-2060 currently on-going in people with end stage renal disease receiving haemodialysis. ...