Blog
RSS FeedPosted by Michael Wonder on 01 Nov 2022
PHARMAC seeks feedback on the funding of paediatric cancer medicines
2 November 2022 - PHARMAC is seeking feedback on rule 8.1b of the Pharmaceutical Schedule – a unique exception that ...
Posted by Michael Wonder on 27 Oct 2022
AvroBio receives rare paediatric disease designation from the US FDA for first in class gene therapy for Gaucher disease
27 October 2022 - AVR-RD-02 has previously received fast track status from FDA, orphan drug designation in the US and EU, ...
Posted by Michael Wonder on 25 Oct 2022
PHARMAC to consider funding the Meningococcal B vaccine but concerns remain
26 October 2022 - PHARMAC has confirmed it will consider funding the Meningococcal B vaccine, which is a crucial tool ...
Posted by Michael Wonder on 25 Oct 2022
PHARMAC considers funding meningococcal B vaccine to be part of childhood immunisations
26 October 2022 - PHARMAC today has announced a consultation on widening access to the meningococcal B vaccine (branded as Bexsero), ...
Posted by Michael Wonder on 21 Oct 2022
Leo Pharma announces European Commission approval of Adtralza (tralokinumab) for the treatment of moderate to severe atopic dermatitis in adolescents
20 October 2022 - Adtralza, a biologic that targets and neutralises the interleukin-13 cytokine, is now approved in Europe for adolescents ...
Posted by Michael Wonder on 19 Oct 2022
EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
19 October 2022 - The EMA’s CHMP has recommended extending the use of Comirnaty and Spikevax targeting the original strain ...
Posted by Michael Wonder on 12 Oct 2022
Eylea (aflibercept) injection sBLA for treatment of retinopathy of prematurity accepted for FDA priority review
12 October 2022 - Regeneron Pharmaceuticals today announced the US FDA has accepted for priority review the supplemental biologics license application ...
Posted by Michael Wonder on 12 Oct 2022
FDA authorises Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose in younger age groups
12 October 2022 - Today, the US FDA amended the emergency use authorisations of the Moderna COVID-19 Vaccine, Bivalent and the ...
Posted by Michael Wonder on 11 Oct 2022
Eligo Bioscience receives FDA orphan drug designation and rare paediatric disease designation for EB003 for the prevention of haemolytic uraemic syndrome with first in class CRISPR based medicine
11 October 2022 - Eligo Bioscience today announced the US FDA has granted orphan drug designation and rare paediatric disease designation ...
Posted by Michael Wonder on 07 Oct 2022
Weekly growth hormone injection hits PBS: Newcastle's Griffin Carters first in Australia to receive life-changing medication
7 October 2022 - A "game-changing" drug that hit the PBS last week has already helped Newcastle's Carters family, the ...
Posted by Michael Wonder on 07 Oct 2022
The critical role of academic clinical trials in paediatric cancer drug approvals: design, conduct, and fit for purpose data for positive regulatory decisions
6 October 2022 - For decades, academic clinical trials consortia have collaborated to optimise outcomes for childhood cancers through evaluating incremental ...
Posted by Michael Wonder on 06 Oct 2022
US FDA accepts Takeda’s supplemental biologics license application for use of Takzyro (lanadelumab-flyo) to prevent hereditary angioedema attacks in children 2 years of age and older
5 October 2022 - Filing is based on data from Phase 3 SPRING study in paediatric patients 2 to <12 years ...
Posted by Michael Wonder on 03 Oct 2022
‘Underlying guilt’ turns to delight after PHARMAC decision
30 September 2022 - Lani McLeod has had an underlying feeling of guilt for two years that her boys had ...
Posted by Michael Wonder on 29 Sep 2022
Catalyst Pharmaceuticals announces FDA approval of supplemental new drug application for Firdapse expanding patient population to include paediatric patients
29 September 2022 - Firdapse is now a treatment option for all LEMS patients 6 years of age and older in ...
Posted by Michael Wonder on 29 Sep 2022
TGA provisionally approves Pfizer’s COVID-19 vaccine, Comirnaty (tozinameran) for use in children aged 6 months to less than 5 years
29 September 2022 - On 29 September 2022, the TGA provisionally approved a paediatric dose of Pfizer’s COVID-19 vaccine, Comirnaty (tozinameran), ...