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 06 Nov 2022
Bulevirtide acetate for the treatment of patients with chronic hepatitis D
4 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 06 Nov 2022
Woman who has to pay $115k for unfunded cancer drug asks: 'What price is a life?'
5 November 2022 - More than anything, Annemarie Hope-Cross wants to live. ...
Posted by Michael Wonder on 06 Nov 2022
Kiwis with rare disorders want faster progress on 'life or death' health strategy
6 November 2022 - For Samantha Lenik, being diagnosed with Pompe disease after seven years of symptoms was a “double-edged ...
Posted by Michael Wonder on 06 Nov 2022
Moderna receives Health Canada authorisation for second Omicron targeting bivalent booster
4 November 2022 - mRNA-1273.222 targets BA.4/BA.5 Omicron sub-variants and follows the approval of mRNA-1273.214 (SPIKEVAX Bivalent) in Canada, which ...
Posted by Michael Wonder on 05 Nov 2022
FDA finalises umbrella trial guidance for cell and gene therapies
4 November 2022 - The US FDA laid out its recommendations for sponsors to study multiple versions of a cellular or ...
Posted by Michael Wonder on 04 Nov 2022
MedinCell’s partner Teva today announced refiling for approval of mdc-IRM and confirmed planned launch in the US in H1 2023
3 November 2022 - MedinCell’s partner, Teva, today announced that it recently completed the re-submission to a new drug application ...
Posted by Michael Wonder on 04 Nov 2022
AVITA Medical announces FDA breakthrough device designations for the Recell system
3 November 2022 - AVITA Medical announced today that the FDA granted the Recell system designations as a breakthrough device for ...
Posted by Michael Wonder on 04 Nov 2022
Beyfortus approved in the EU for the prevention of RSV lower respiratory tract disease in infants
4 November 2022 - European Commission grants first approval worldwide following positive CHMP opinion in September. ...
Posted by Michael Wonder on 04 Nov 2022
Changes announced to Rebif listing on PBS
3 November 2022 - From 1 December 2022, Rebif will no longer be available on the PBS for Australians living with ...
Posted by Michael Wonder on 04 Nov 2022
Iveric Bio announces submission of first part of NDA for rolling review of avacincaptad pegol for the treatment of geographic atrophy
3 November 2022 - IVERIC bio today announced that it has submitted to the US FDA the first part of ...
Posted by Michael Wonder on 04 Nov 2022
Apellis announces plans to submit 24 month Phase 3 data to the FDA for pegcetacoplan NDA for geographic atrophy
3 November 2022 - Submission will be a major amendment to the new drug application, extending the review period by ...
Posted by Michael Wonder on 04 Nov 2022
Health Canada expands Tresiba (insulin degludec injection) label with efficacy and safety for use in pregnant women with diabetes
3 November 2022 - Tresiba, Canada's leading basal insulin, now approved for use during pregnancy. ...
Posted by Michael Wonder on 04 Nov 2022
Codagenix receives FDA fast track designation for live attenuated, intranasal RSV vaccine candidate CodaVax-RSV
2 November 2022 - Codagenix today announced that the US FDA has granted fast track designation to CodaVax-RSV, an intranasal, live ...
Posted by Michael Wonder on 03 Nov 2022
Advocate 'gutted' as PHARMAC reviews blanket funding of child cancer medicines
2 November 2022 - Rule 8.1b of the Pharmaceutical Schedule allows all child cancer medicines to be funded by PHARMAC. ...
Posted by Michael Wonder on 03 Nov 2022
Health Canada authorises second bivalent COVID-19 booster targeting the Omicron BA.4/5 variants
3 November 2022 - Today, Health Canada authorised an adapted version of the Moderna Spikevax COVID-19 vaccine that targets the Omicron ...