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 16 Jul 2024
Elranatamab for the treatment of patients with relapsed and refractory multiple myeloma after three or more treatments
12 July 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 16 Jul 2024
SMC - July 2024 decisions
8 July 2024 - Voretigene neparvovec (Luxturna) was accepted for the treatment of adults and children with an extremely rare inherited ...
Posted by Michael Wonder on 16 Jul 2024
AusperBio receives breakthrough therapy designation for AHB-137 in chronic hepatitis B treatment
10 July 2024 - AHB-137 gains breakthrough therapy designation from the NMPA based on Phase 1/Phase2a clinical trial data demonstrating safety ...
Posted by Michael Wonder on 16 Jul 2024
Arrivo announces FDA fast track designation for RABI-767 for patients with acute pancreatitis predicted to progress to severe disease
15 July 2024 - RABI-767 is a novel lipase inhibitor currently in a Phase 2a clinical trial. ...
Posted by Michael Wonder on 16 Jul 2024
Sumitomo Pharma announces that DSP-5336 has received FDA fast track designation for the treatment of relapsed or refractory acute myeloid leukaemia
15 July 2024 - -- Sumitomo Pharma today announced that the US FDA granted fast track designation to DSP-5336 for ...
Posted by Michael Wonder on 16 Jul 2024
Doug Ford wants Canada to approve drugs faster. Is that possible?
15 July 2024 - Talk of the delay in drugs is top of mind for Ford, who arrived in Nova Scotia ...
Posted by Michael Wonder on 16 Jul 2024
Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for people with cystic fibrosis aged 2 years and older with certain rare mutations
15 July 2024 - Approximately 200 people with certain rare CF mutations are now eligible for Trikafta. ...
Posted by Michael Wonder on 15 Jul 2024
Clinical benefit, reimbursement outcomes, and prices of FDA approved cancer drugs reviewed through Project Orbis in the USA, Canada, England, and Scotland: a retrospective, comparative analysis
11 July 2024 - Project Orbis is a global initiative that aims to streamline regulatory review processes across international regulators in ...
Posted by Michael Wonder on 15 Jul 2024
Onco360 selected as a limited distribution specialty pharmacy partner for Rytelo (imetelstat)
12 July 2024 - Onco360 has been selected as a pharmacy partner by Geron Corporation for Rytelo (imetelstat) as a ...
Posted by Michael Wonder on 15 Jul 2024
PHARMAC proposal to increase access to five medicines for cancer and other health conditions
12 July 2024 - PHARMAC is looking to increase access to five medicines for a number of cancers, including kidney ...
Posted by Michael Wonder on 14 Jul 2024
Fresenius announces EMA validation of marketing authorisation application for denosumab biosimilar candidates
11 July 2024 - Fresenius, via its operating company Fresenius Kabi, announced that the EMA has accepted for review the company’s ...
Posted by Michael Wonder on 13 Jul 2024
Innorna announces US FDA rare paediatric disease designation granted to IN016 for the treatment of progressive familial intrahepatic cholestasis
11 July 2024 - Innorna today announced that the US FDA has granted rare paediatric disease designation to IN016, one of ...
Posted by Michael Wonder on 13 Jul 2024
Health Canada approves Tagrisso with the addition of chemotherapy for patients with EGFR mutated advanced lung cancer
12 July 2024 - Approval based on FLAURA2 results, which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 13 Jul 2024
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in giant cell arteritis
12 July 2024 - Submissions are supported by the Phase 3 SELECT-GCA study demonstrating upadacitinib 15 mg with a 26 week ...
Posted by Michael Wonder on 13 Jul 2024
FDA grants fast track designation to 9MW2821 for the treatment of patients with locally advanced or metastatic nectin-4 positive TNBC
12 July 2024 - Mabwell announces that its self-developed novel nectin-4-targeting ADC (9MW2821) has been granted fast track designation by the ...