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 01 Mar 2023
Cytokinetics receives complete response letter from FDA for new drug application for omecamtiv mecarbil
28 February 2023 - Complete response letter states that GALACTIC-HF alone does not establish substantial evidence of effectiveness sufficient for approval. ...
Posted by Michael Wonder on 01 Mar 2023
Kevzara (sarilumab) approved by FDA as first and only biologic indicated for patients with polymyalgia rheumatica
28 February 2023 - Three times more patients treated with Kevzara achieved sustained remission compared to placebo in Phase 3 trial. ...
Posted by Michael Wonder on 01 Mar 2023
ATAGI recommendations on use of the Moderna bivalent (Original/Omicron BA.4/5) COVID-19 vaccine
28 February 2023 - Recommendations from the Australian Technical Advisory Group on Immunisation (ATAGI) on the use of the Moderna bivalent ...
Posted by Michael Wonder on 01 Mar 2023
Reata Pharmaceuticals announces FDA approval of Skyclarys (omavaloxolone), the first and only drug indicated for patients with Friedreich’s ataxia
28 February 2023 - Rare paediatric disease priority review voucher granted. ...
Posted by Michael Wonder on 28 Feb 2023
US FDA accepts Bristol Myers Squibb’s supplemental biologics license application and EMA validates application for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma
28 February 2023 - The applications are based on results from the Phase 3 CheckMate-76K trial, in which Opdivo demonstrated a ...
Posted by Michael Wonder on 28 Feb 2023
Baricitinib for the treatment of patients with severe alopecia areata
28 February 2023 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 28 Feb 2023
Drugs likely subject to Medicare negotiation (2026-2028)
28 February 2023 - In 2026-2028, we estimate that Medicare will negotiate prices for 38 Medicare Part D drugs and 2 ...
Posted by Michael Wonder on 28 Feb 2023
Schedule of Pharmaceutical Benefits - 1 March 2023
1 March 2023 - The March 2023 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 28 Feb 2023
My son’s time is running out due to a rare disease. The FDA needs to add more clinical trial flexibility.
28 February 2023 - My toddler, Wheeler, will probably not live to adulthood. Juvenile Batten disease — he has the ...
Posted by Michael Wonder on 28 Feb 2023
New Zealand Pharmaceutical Schedule - 1 March 2023
1 March 2023 - The March 2023 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 28 Feb 2023
CStone announces China’s NMPA has accepted the supplementary new drug application of sugemalimab as first-line treatment for patients with locally advanced or metastatic gastric/gastro-oesophageal junction adenocarcinoma
28 February 2023 - This supplementary new drug application was filed for the fourth indication for sugemalimab in China, following applications ...
Posted by Michael Wonder on 28 Feb 2023
Darolutamide receives approval for additional prostate cancer indication in Japan
27 February 2023 - New approval is based on data from the pivotal Phase 3 ARASENS trial. ...
Posted by Michael Wonder on 28 Feb 2023
Biologics license application for lecanemab designated for priority review by China NMPA
28 February 2023 - Eisai and Biogen announced today that the biologics license application for lecanemab (brand name in the US: ...
Posted by Michael Wonder on 28 Feb 2023
PHARMAC will fund meningococcal B vaccine for babies, teens and young people
28 February 2023 - From Wendesday, PHARMAC will fund meningococcal B vaccine for a number of potentially at-risk groups including ...
Posted by Michael Wonder on 28 Feb 2023
“Killing time” one year on, still no final response from PHARMAC to the independent review
28 February 2023 - Today marks one year since the PHARMAC Review was delivered to then Health Minister Andrew Little. ...