Blog
RSS FeedPosted by Michael Wonder on 09 Jul 2025
Supplemental new drug application submitted to US FDA for Caplyta (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo
8 July 2025 - Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in ...
Posted by Michael Wonder on 09 Jul 2025
PBS ‘not on the table’ in battle for pharmaceutical tariff exemption, despite lobbying
9 July 2025 - The threat of global 200 per cent tariffs on pharmaceutical products presents a challenge to Australia’s drug ...
Posted by Michael Wonder on 08 Jul 2025
Drug reimbursement panel approves iptacopan for PNH reimbursement, rejects danicopan over cost concerns
7 March 2025 - The Pharmaceutical Reimbursement Review Committee has made mixed decisions on the two medicines for paroxysmal nocturnal ...
Posted by Michael Wonder on 08 Jul 2025
Lexeo Therapeutics announces FDA breakthrough therapy designation for LX2006 in Friedreich ataxia
7 July 2025 - Breakthrough therapy designation based on interim clinical data from Phase I/II trials showing clinically meaningful improvements in ...
Posted by Michael Wonder on 08 Jul 2025
Denali Therapeutics announces FDA acceptance and priority review of biologics license application for tividenofusp alfa for Hunter syndrome
7 July 2025 - FDA assigns PDUFA target action date of 5 January 2026, for decision on accelerated approval. ...
Posted by Michael Wonder on 07 Jul 2025
KalVista Pharmaceuticals announces FDA Approval of Ekterly (sebetralstat), first and only oral on-demand treatment for hereditary angioedema
7 July 2025 - First new on demand hereditary angioedema treatment in over a decade, with potential to transform management of the ...
Posted by Michael Wonder on 07 Jul 2025
Will miracle HIV drug go on the PBS?
5 July 2025 - A new twice yearly antiviral injection that can prevent HIV is likely to be approved soon in ...
Posted by Michael Wonder on 06 Jul 2025
Garadacimab for the prevention of recurrent attacks of hereditary angioedema in patients 12 years of age and older
2 July 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 06 Jul 2025
MHRA approves nogapendekin alfa inbakicept to treat adult patients with non-muscle invasive bladder cancer
4 July 2025 - The MHRA has today approved nogapendekin alfa inbakicept (Anktiva) for adults with BCG unresponsive non-muscle invasive bladder ...
Posted by Michael Wonder on 05 Jul 2025
Quebec implements public reimbursement of Pluvicto - a defining milestone for radioligand therapy in Canada
3 July 2025 - Pluvicto now publicly funded in provinces covering most Canadians, offering renewed hope to those facing progressive PSMA ...
Posted by Michael Wonder on 05 Jul 2025
Teprotumumab for the treatment of patients with thyroid eye disease
2 July 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 05 Jul 2025
European Commission approves Biocon biologics’ denosumab biosimilars
3 July 2025 - Biocon Biologics today announced that the European Commission has granted marketing authorisation in the European Union ...
Posted by Michael Wonder on 04 Jul 2025
Vertex Announces European Commission approval of Alyftek, a new once daily CFTR modulator for the treatment of cystic fibrosis
1 July 2025 - Approximately 31,000 people with cystic fibrosis in the EU are now eligible for this new highly ...
Posted by Michael Wonder on 04 Jul 2025
Public Summary Documents - March 2025 PBAC meeting
4 July 2025 - The Public Summary Documents (first time decisions not to recommend and deferrals) from the March 2025 ...
Posted by Michael Wonder on 04 Jul 2025
Imfinzi approved in the EU as first and only peri-operative immunotherapy for muscle-invasive bladder cancer
4 July 2025 - Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk ...