Blog
RSS FeedPosted by Michael Wonder on 25 Apr 2024
Bashing accelerated approval isn’t supported by the data
24 April 2024 - The FDA’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and ...
Posted by Michael Wonder on 02 Apr 2024
Mirum Pharmaceuticals’ Livmarli (maralixibat oral solution) receives positive reimbursement recommendation by Canada’s CADTH for patients with cholestatic pruritus in Alagille syndrome
2 April 2024 - Positive HTA recommendation for reimbursement signifies an important milestone towards public funding to treat eligible patients with ...
Posted by Michael Wonder on 02 Apr 2024
Cancer experts urge PHARMAC to fast-track 'life-saving' Keytruda
2 April 2024 - Breast cancer experts have urged PHARMAC to fast-track the drug Keytruda, for Kiwis with an aggressive ...
Posted by Michael Wonder on 02 Apr 2024
Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated metastatic HR positive, HER2 negative breast cancer
2 April 2024 - Application based on results from the TROPION-Breast01 Phase 3 trial. ...
Posted by Michael Wonder on 02 Apr 2024
Vamorolone for the treatment of patients with Duchenne muscular dystrophy
28 March 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 02 Apr 2024
BMS’ oral plaque psoriasis drug Sotyktu gets reimbursement starting April
1 April 2024 - Starting this month, Sotyktu (deucravacitinib), an oral treatment for moderate to severe plaque psoriasis in adults, ...
Posted by Michael Wonder on 02 Apr 2024
Relugolix–estradiol–norethisterone acetate for the treatment of patients with pain associated with endometriosis
28 March 2024 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...
Posted by Michael Wonder on 02 Apr 2024
Merck’s superovulation induction drug Pergoveris gets expanded coverage
1 April 2024 - Merck Biopharma Korea's superovulation induction injection Pergoveris (follitropin alfa) will receive expanded reimbursement to treat patients ...
Posted by Michael Wonder on 01 Apr 2024
PHARMAC publishes agenda for May 2024 PTAC meeting
28 March 2024 - Another slim agenda; one cancer medicine. ...
Posted by Michael Wonder on 01 Apr 2024
Voydeya approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular haemolysis in adults with the rare disease PNH
1 April 2024 - Approval of first in class, oral, Factor D inhibitor based on results from pivotal ALPHA Phase ...
Posted by Michael Wonder on 01 Apr 2024
Eisai completes submission of Leqembi (lecanemab-irmb) supplemental biologics license application for IV maintenance dosing for the treatment of early Alzheimer’s disease to the US FDA
1 April 2024 - Eisai and Biogen announced today that Eisai submitted to the US FDA a supplemental biologics license ...
Posted by Michael Wonder on 01 Apr 2024
US FDA accepts Astellas’ supplemental new drug application for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
1 April 2024 - Target action date set for 19 November 2024. ...
Posted by Michael Wonder on 31 Mar 2024
Schedule of Pharmaceutical Benefits - 1 April 2024
1 April 2024 - The April 2024 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 Mar 2024
New Zealand Pharmaceutical Schedule - 1 April 2024
1 April 2024 - The April 2024 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 30 Mar 2024
FDA Approves Medexus's supplemental biologics license application for Ixinity to treat haemophilia B in paediatric patients
26 March 2024 - Expanded indication includes patients under 12 years of age, based on Phase 3/4 data demonstrating safety and ...
Posted by Michael Wonder on 29 Mar 2024
LISCure Biosciences receives US FDA fast track designation for LB-P8 for the treatment of primary sclerosing cholangitis
29 March 2024 - Phase 2 study is underway and LB-P8 is the only live biotherapeutic product currently reported to be ...