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 20 May 2022
CHMP recommends approval of Lilly and Incyte's Olumiant (baricitinib) as the first and only centrally authorised treatment for adults with severe alopecia areata
20 May 2022 - Eli Lilly and Incyte announced today that the EMA's CHMP has issued a positive opinion for ...
Posted by Michael Wonder on 20 May 2022
AbbVie submits new drug application to U.S. FDA for investigational ABBV-951 (foscarbidopa/foslevodopa) for the treatment of advanced Parkinson's disease
20 May 2022 - Submission is supported by Phase 3 study that demonstrated patients had significant increases in hours of ...
Posted by Michael Wonder on 20 May 2022
Highlights from the 16-19 May 2022 CHMP meeting
20 May 2022 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its May 2022 meeting. ...
Posted by Michael Wonder on 20 May 2022
Lumasiran for treating primary hyperoxaluria type 1
20 May 2022 - The Department of Health and Social Care has asked NICE to produce guidance on using lumasiran ...
Posted by Michael Wonder on 20 May 2022
Viatris and Biocon Biologics launch Abevmy (bevacizumab), their third oncology siosimilar, in Canada
19 May 2022 - Viatris and Biocon Biologics announced today that Abevmy (bevacizumab) is now available in Canada. ...
Posted by Michael Wonder on 20 May 2022
Mirati Therapeutics submits marketing authorisation application to the European Medicines Agency for investigational adagrasib as a treatment for previously treated KRASG12C mutated non-small-cell lung cancer
19 May 2022 - Submission follows the U.S. FDA acceptance of the adagrasib new drug application for the same indication ...
Posted by Michael Wonder on 19 May 2022
NeuroMetrix reports that Quell wearable neuromodulation device has received FDA de novo authorisation as first non-pharmacological treatment for fibromyalgia
19 May 2022 - NeuroMetrix today announced U.S. FDAde novo authorisation to market the Quell neuromodulation device as an ...
Posted by Michael Wonder on 19 May 2022
Medicines Australia puts spotlight on reform priority for the next Government
20 May 2022 - Medicines Australia has set the scene for major health reform by the next Government by alerting ...
Posted by Michael Wonder on 19 May 2022
Plea to make new depression 'spray' affordable
19 May 2022 - Mental health experts say a nasal spray to help relieve depression should be subsidised to make ...
Posted by Michael Wonder on 19 May 2022
Major parties committed to major medicines policy reform and reviews – whoever wins on Saturday
19 May 2022 - Medicines Australia has been assured in official communications from the respective Campaign Headquarters that both the ...
Posted by Michael Wonder on 19 May 2022
BMS’ Sprycel reimbursement criteria to be broadened for paediatric Philadelphia chromosome positive ALL
19 May 2022 - The state health insurance review agency said it would broaden the reimbursement criteria for Sprycel (dasatinib), ...
Posted by Michael Wonder on 19 May 2022
Budget 2022: critically ill patients 'bitterly disappointed' by PHARMAC funding
19 May 2022 - Critically ill patients say they're "bitterly disappointed" by today's PHARMAC Budget announcement and were left looking ...
Posted by Michael Wonder on 19 May 2022
G-BA certifies active ingredients against breast and oesophageal cancer as having a high additional benefit
19 May 2022 - The Federal Joint Committee (G-BA) has rated the patient-relevant additional benefit of two active ingredients for cancer ...
Posted by Michael Wonder on 19 May 2022
SIGA receives approval from the FDA for intravenous formulation of Tpoxx (tecovirimat)
19 May 2022 - FDA approval provides an important option for those unable to take oral formulation of Tpoxx. ...
Posted by Michael Wonder on 19 May 2022
Budget 2022: PHARMAC boost leaves patients cold: 'it won't be enough'
19 May 2022 - PHARMAC has had its biggest ever funding boost, but some New Zealanders fear it still won’t ...