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 Dec 2020
Mirum Pharmaceuticals announces European Medicines Agency validation of the marketing authorisation application for maralixibat in patients with PFIC2
30 November 2020 - Five-year transplant-free survival data from the Phase 2 INDIGO study used as the basis for the MAA ...
Posted by Michael Wonder on 01 Dec 2020
ARS announces acceptance of market authorisation application submission to European Medicines Agency for Neffy (ARS-1; epinephrine nasal spray)
30 November 2020 - ARS Pharmaceuticals announced today that the EMA has accepted a marketing authorisation application submission for review of ...
Posted by Michael Wonder on 01 Dec 2020
Kadmon announces FDA acceptance of NDA for belumosudil in patients with chronic graft versus host disease
30 November 2020 - Application being evaluated Under FDA's Real-Time Oncology Review and Project Orbis pilot programs. ...
Posted by Michael Wonder on 01 Dec 2020
ICER releases draft evidence report on therapies for anaemia in chronic kidney disease
30 November 2020 - Public comment period now open until 5 January 2021; requests to make oral comment during public meeting ...
Posted by Michael Wonder on 01 Dec 2020
Karolinska Development's portfolio company Aprea Therapeutics receives FDA fast track designation for eprenetapopt in AML
30 November 2020 - Karolinska Development announces today that the U.S. FDA has granted fast track designation for eprenetapopt in the ...
Posted by Michael Wonder on 30 Nov 2020
Now more than ever, the fight against HIV must continue
1 December 2020 - To mark World AIDS Day 2020 and support the ‘now more than ever’ theme, the Morrison Government ...
Posted by Michael Wonder on 30 Nov 2020
Astellas receives approval of Evrenzo (roxadustat) in Japan for the treatment of anaemia of chronic kidney disease in adult patients not on dialysis
27 November 2020 - Approval by MHLW provides new HIF-PH inhibitor treatment option for healthcare providers and adult patients with ...
Posted by Michael Wonder on 30 Nov 2020
Canada to Trump: you can't take our prescription drugs
30 November 2020 - Canada is putting the kibosh on President Donald Trump's efforts to lower drug prices by importing ...
Posted by Michael Wonder on 30 Nov 2020
Zymeworks receives FDA breakthrough therapy designation for HER2-targeted bispecific antibody zanidatamab in patients with biliary tract cancer
30 November 2020 - Zymeworks today announced that the U.S. FDA has granted breakthrough therapy designation for zanidatamab in patients with ...
Posted by Michael Wonder on 30 Nov 2020
Moderna submits vaccine for FDA regulatory approval
30 November 2020 - Recent vaccine developments have been met with optimism among scientists and stock markets, but experts also urge ...
Posted by Michael Wonder on 30 Nov 2020
ICER Analytics launched to accelerate the real world application of ICER reports, helping payers, the life science industry, and health care policy makers move from insight to action
30 November 2020 - The Institute for Clinical and Economic Review today formally launched ICER Analytics, a new cloud-based platform that ...
Posted by Michael Wonder on 30 Nov 2020
Schedule of Pharmaceutical Benefits - 1 December 2020 update
1 December 2020 - The December 2020 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 30 Nov 2020
New Zealand Pharmaceutical Schedule - 1 December 2020
1 December 2020 - The December 2020 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 30 Nov 2020
UK secures another two million doses of Moderna’s COVID-19 vaccine
30 November 2020 - The UK government has secured an additional two million doses of Moderna’s COVID-19 vaccine mRNA-1273, taking ...
Posted by Michael Wonder on 30 Nov 2020
Forxiga approved in Japan for chronic heart failure
30 November 2020 - Forxiga is the first SGLT2 inhibitor approved in Japan for chronic heart failure with reduced ejection ...