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RSS FeedPosted by Michael Wonder on 04 Jan 2022
TGA grants provisional determination to AstraZeneca for COVID-19 prophylaxis and treatment, tixagevimab and cilgavimab (Evusheld)
4 January 2022 - On 4 January 2022, the TGA granted a further provisional determination to AstraZeneca in relation to ...
Posted by Michael Wonder on 31 Dec 2021
Amylyx Pharmaceuticals announces FDA acceptance and priority review of new drug application for AMX0035 for the treatment of ALS
29 December 2021 - Amylyx Pharmaceuticals today announced that the U.S. FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 15 Dec 2021
Valeo Pharma obtains public reimbursement for Enerzair Breezhaler and Atectura Breezhaler in Quebec and Nova Scotia
15 December 2021 - Public reimbursement now includes Alberta, Quebec and Nova Scotia, representing approximately 37% of the Canadian population. ...
Posted by Michael Wonder on 13 Dec 2021
Veru announces FDA approval of Entadfi, a new treatment for benign prostatic hyperplasia
13 December 2021 - Commercialisation will start early calendar year 2022. ...
Posted by Michael Wonder on 09 Dec 2021
Heron Therapeutics announces FDA approval of a significant indication expansion for Zynrelef
9 December 2021 - Approval provides a significantly broader indication for Zynrelef, now covering approximately 7 million procedures a year. ...
Posted by Michael Wonder on 29 Nov 2021
Mayne Pharma and Mithra announce TGA approval of Nextstellis oral contraceptive
29 November 2021 - Mayne Pharma and Mithra Pharmaceuticals are very pleased to announce the TGA has approved the novel combined ...
Posted by Michael Wonder on 22 Nov 2021
Vertex announces reimbursement agreement in Spain for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat people with cystic fibrosis 12 years and older with at least one F508del mutation in the CFTR gene
19 November 2021 - With this reimbursement agreement approximately 700 people with cystic fibrosis now have access to a CFTR ...
Posted by Michael Wonder on 09 Nov 2021
TGA grants provisional determination to AstraZeneca for COVID-19 preventative treatment, tixagevimab and cilgavimab (Evusheld)
9 November 2021 - On 4 November 2021, the TGA granted provisional determination to AstraZeneca in relation to the COVID-19 treatment ...
Posted by Michael Wonder on 04 Nov 2021
A breakthrough treatment for cystic fibrosis needs funding now
3 November 2021 - Let’s just kick this off by addressing the elephant in the room. Trikafta, the breakthrough treatment ...
Posted by Michael Wonder on 03 Nov 2021
Valeo Pharma obtains public reimbursement for Enerzair Breezhaler and Atectura Breezhaler in Alberta
3 November 2021 - First provincial public listing secured for both asthma medications. ...
Posted by Michael Wonder on 27 Oct 2021
Vertex's supplement to a new drug aubmission for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 6-11 accepted for priority review by Health Canada
27 October 2021 - Vertex Pharmaceuticals today announced that its supplement to a new drug submission for Trikafta (elexacaftor/tezacaftor/ivacaftor and ...
Posted by Michael Wonder on 26 Oct 2021
Cystic fibrosis medicine added to PHARMAC's options for investment list
27 October 2021 - PHARMAC has announced that Vertex’s triple combination modulator therapy, known in some countries as Trikafta, has ...
Posted by Michael Wonder on 18 Oct 2021
US FDA approves expanded indication of Gilead’s Biktarvy for treatment of HIV-1 in paediatric populations
18 October 2021 - FDA approves low dose tablet for HIV treatment in virologically suppressed children weighing at least 14 kg. ...
Posted by Michael Wonder on 18 Oct 2021
TGA provisional approval of Roche COVID-19 treatment, casirivimab with imdevimab (Ronapreve)
18 October 2021 - The TGA has provisionally approved the use of the Roche combination therapy, casirivimab + imdevimab (Ronapreve) ...
Posted by Michael Wonder on 20 Sep 2021
Vertex announces letter of intent with pan-Canadian Pharmaceutical Alliance for public reimbursement of CFTR modulators Extended to Include Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
17 September 2021 - Vertex Pharmaceuticals today announced that it has signed a letter of intent with the pan-Canadian Pharmaceutical ...