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 06 Dec 2020
Strengthening Australia's immunisation program
3 December 2020 - The Australian Government is continuing to improve Australia’s world leading vaccination program through the Australian Immunisation Register ...
Posted by Michael Wonder on 05 Dec 2020
FDA approves weight management drug for patients aged 12 and older
4 December 2020 - The U.S. FDA has approved Saxenda (liraglutide) for chronic weight management among patients aged 12 and older ...
Posted by Michael Wonder on 05 Dec 2020
Pfizer slashes its original COVID-19 vaccine rollout target after supply-chain obstacles
4 December 2020 - Pfizer expects to ship half of the COVID-19 vaccines it originally planned for this year because ...
Posted by Michael Wonder on 04 Dec 2020
Novo Nordisk files for US FDA regulatory approval of once-weekly semaglutide 2.4 mg for weight management
4 December 2020 - Novo Nordisk today announced the submission of a new drug application to the US FDA for subcutaneous ...
Posted by Michael Wonder on 04 Dec 2020
BioCryst announces FDA approval of Orladeyo (berotralstat), first oral, once-daily therapy to prevent attacks in hereditary angioedema patients
3 December 2020 - Significant and sustained reduction in HAE attacks. ...
Posted by Michael Wonder on 04 Dec 2020
ICER opens nominations for new members of its voting panels
2 December 2020 - Independent panel members debate the evidence on the effectiveness and value of new drugs and other ...
Posted by Michael Wonder on 04 Dec 2020
Access Consortium statement on COVID-19 vaccines evidence
4 December 2020 - The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the ...
Posted by Michael Wonder on 04 Dec 2020
enGene receives fast track designation for EG-70 for the treatment of non-muscle invasive bladder cancer
3 December 2020 - enGene announced today that the U.S. FDA has granted fast track designation to enGene for EG-70, the ...
Posted by Michael Wonder on 04 Dec 2020
COVID-19 vaccine will be free of charge, 1 million inoculations set for January, French PM say
3 December 2020 - After the vaccination of an initial 1 million people in January an additional 14 million at ...
Posted by Michael Wonder on 04 Dec 2020
PHARMAC inquiry: “nothing should be off the table”
4 December 2020 - Medicines New Zealand, the industry association representing companies involved in the research, development and manufacture of ...
Posted by Michael Wonder on 04 Dec 2020
Proposal to widen access to rituximab for treatment of membranous nephropathy
4 December 2020 - PHARMAC is seeking feedback on a proposal to widen access to rituximab. ...
Posted by Michael Wonder on 03 Dec 2020
Catalyst Biosciences receives FDA fast track designation for subcutaneous MarzAA for the treatment of episodic bleeding in haemophilia A or B with inhibitors
2 December 2020 - Catalyst Biosciences today announced the U.S. FDA has granted fast track designation for marzeptacog alfa (activated) – ...
Posted by Michael Wonder on 03 Dec 2020
Genmab announces that Janssen has submitted a biologics license application to U.S. FDA for amivantamab in non-small cell lung cancer
3 December 2020 - First regulatory submission for a DuoBody product candidate. ...
Posted by Michael Wonder on 03 Dec 2020
Secukinumab in children with plaque psoriasis: study unsuitable for benefit assessment
3 December 2020 - Inappropriate treatment in the control arm makes fair comparison impossible. ...
Posted by Michael Wonder on 03 Dec 2020
Fate of 250,000 diabetics in PHARMAC’s hands
3 December 2020 - This week, a small group of bureaucrats and health professionals will meet to agree on the ...