Blog
RSS FeedPosted by Michael Wonder on 04 Dec 2022
Anti-viral drug should not be first choice in treating COVID-19
3 December 2022 - The most widely prescribed anti-viral drug in Australia, molnupiravir, should no longer be routinely given for ...
Posted by Michael Wonder on 04 Dec 2022
PHARMAC seeking feedback on funding Trikafta
4 December 2022 - PHARMAC has reached a provisional agreement with medicine supplier Vertex to fund Trikafta. ...
Posted by Michael Wonder on 04 Dec 2022
Anti-viral COVID-19 treatment now available in the Netherlands for 1,250 Euros
1 December 2022 - The anti-viral medication approved to treat COVID-19 is now available on the Dutch market, the Dutch Association ...
Posted by Michael Wonder on 04 Dec 2022
Statistical approaches to establishing bioequivalence
2 December 2022 - Requirements for submitting bioavailability and bioequivalence data in investigational new drugs, new drug applications, abbreviated new drug ...
Posted by Michael Wonder on 04 Dec 2022
EMA validates application for arpraziquantel to treat schistosomiasis in pre-school aged children
2 December 2022 - Merck, a leading science and technology company, and the Pediatric Praziquantel Consortium, today announced that the EMA ...
Posted by Michael Wonder on 04 Dec 2022
Brexucabtagene autoleucel for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukaemia
2 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...
Posted by Michael Wonder on 03 Dec 2022
Orchard Therapeutics announces Swissmedic validation of the marketing authorisation application for Libmeldy (atidarsagene autotemcel)
1 December 2022 - Orchard Therapeutics today announced its marketing authorisation application for Libmeldy (atidarsagene autotemcel) has been accepted for ...
Posted by Michael Wonder on 03 Dec 2022
European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
2 December 2022 - Application includes data from key Phase 3 trials, including the pivotal MOMENTUM trial, which met all ...
Posted by Michael Wonder on 03 Dec 2022
AbbVie announces provincial reimbursement for Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis and psoriatic arthritis in Alberta, New Brunswick, Ontario, Quebec and Saskatchewan
1 December 2022 - AbbVie today announced that Rinvoq is now listed as a special authorisation medication or exception medication status ...
Posted by Michael Wonder on 03 Dec 2022
Hopes $55k breast cancer drug Keytruda will get PBS listing
3 December 2022 - Women with triple negative breast cancer have been given new hope that immunotherapy drug Keytruda will ...
Posted by Michael Wonder on 03 Dec 2022
EQRx announces acceptance of marketing authorisation application by the European Medicines Agency for aumolertinib in EGFR mutated non-small-cell lung cancer
2 December 2022 - Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line ...
Posted by Michael Wonder on 03 Dec 2022
COVID-19 vaccine safety report (1 December 2022)
1 December 2022 - To 27 November 2022, the TGA has received 709 reports which have been assessed as likely to ...
Posted by Michael Wonder on 02 Dec 2022
FDA approves olutasidenib for relapsed or refractory acute myeloid leukaemia with a susceptible IDH1 mutation
1 December 2022 - Today, the FDA approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid ...
Posted by Michael Wonder on 02 Dec 2022
Tezepelumab for the treatment of patients with severe asthma
2 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...
Posted by Michael Wonder on 02 Dec 2022
Y-mAbs announces complete response letter for omburtamab biologics license application
1 December 2022 - Y-mAbs Therapeutics today announced that the US FDA has issued a complete response letter for the ...