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 02 Feb 2021
Is it time to stop using statistical significance?
1 February 2021 - The important first step in the critical appraisal of a randomised trial is not an evaluation ...
Posted by Michael Wonder on 02 Feb 2021
COVID‑19 vaccines – are we there yet?
1 February 2021 - The novel coronavirus SARS-CoV-2, the cause of the COVID-19 pandemic, is a highly infectious human respiratory ...
Posted by Michael Wonder on 02 Feb 2021
Mirum Pharmaceuticals announces completion of rolling NDA submission for maralixibat in Alagille syndrome
1 February 2021 - Maralixibat U.S. launch expected in second half of 2021, if approved. ...
Posted by Michael Wonder on 02 Feb 2021
Bristol Myers Squibb application for Zeposia (ozanimod) for the treatment of ulcerative colitis accepted for filing with priority review by U.S. FDA
1 February 2021 - U.S. Food and Drug Administration assigned an action date of 30 May 2021. ...
Posted by Michael Wonder on 02 Feb 2021
Celltrion Healthcare receives Health Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima SC, for the treatment of people with rheumatoid arthritis
1 February 2021 - This novel formulation provides an alternative administration option for Canadian physicians and their patients. ...
Posted by Michael Wonder on 01 Feb 2021
Vyne Therapeutics announces FDA approval of Amzeeq (minocycline) label ppdate
1 February 2021 - Vyne Therapeutics today announced approval by the U.S. FDA to include new information in the product ...
Posted by Michael Wonder on 01 Feb 2021
EU nations have received 18.5 million COVID-19 vaccines
2 February 2021 - Seeking to rebound from heavy criticism of its slow coronavirus vaccine rollout, the European Union said ...
Posted by Michael Wonder on 01 Feb 2021
Merck receives positive EU CHMP opinion for expanded approval of Keytruda (pembrolizumab) in certain patients with relapsed or refractory classical Hodgkin lymphoma
1 February 2021 - Opinion granted based on significant progression-free survival benefit demonstrated with Keytruda monotherapy compared to brentuximab vedotin in ...
Posted by Michael Wonder on 01 Feb 2021
Patient advocate slams cancer agency report over 'wall of silence' on PHARMAC funding
2 February 2021 - The Cancer Control Agency has released its first report into cancer in New Zealand, but one patient ...
Posted by Michael Wonder on 01 Feb 2021
Adamas announces FDA approval for second indication for Gocovri as an adjunctive treatment to levodopa/carbidopa in Parkinson’s disease patients experiencing OFF episodes
1 February 2021 - Gocovri is now the first and only medication approved to treat OFF and dyskinesia motor complications. ...
Posted by Michael Wonder on 01 Feb 2021
Biogen announces FDA approval of Plegridy (peginterferon beta-1a) intramuscular administration for multiple sclerosis
1 February 2021 - Intramuscular injection Plegridy (peginterferon beta-1a) is now approved in the U.S. and the European Union, offering individuals ...
Posted by Michael Wonder on 01 Feb 2021
Incyte announces positive CHMP opinion for pemigatinib for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement
29 January 2021 - If approved, pemigatinib will be the first targeted therapy indicated in the EU for this indication. ...
Posted by Michael Wonder on 01 Feb 2021
CSL to deliver one million Australian-manufactured COVID-19 vaccines a week from the end of March
1 February 2021 - CSL, the nation’s biggest health company, has brought forward its first delivery of an Australian-produced COVID-19 ...
Posted by Michael Wonder on 01 Feb 2021
EMA starts rolling review of REGN-COV2 antibody combination (casirivimab/imdevimab)
1 February 2021 - EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a medicine known ...
Posted by Michael Wonder on 01 Feb 2021
When is a medicine currently under review by the TGA not under evaluation?
1 February 2021 - The approval of the first new medicine for 2021 raises an interesting question. ...