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RSS FeedPosted by Michael Wonder on 03 Aug 2023
Jazz Pharmaceuticals enters into letter of intent with the pan-Canadian Pharmaceutical Alliance for Rylaze, helping address the unmet need of acute lymphoblastic leukaemia and lymphoblastic lymphoma patients across Canada
2 August 2023 - Jazz Pharmaceuticals today announced that the Company has entered into a letter of intent with the pan-Canadian ...
Posted by Michael Wonder on 03 Aug 2023
Health Canada authorises Tecvayli (teclistamab injection), a first in class bispecific antibody for the treatment of patients with relapsed or refractory multiple myeloma
2 August 2023 - Approval for Tecvayli, a subcutaneously administered therapy, is based on results from the Phase 1/2 MajesTEC-1 ...
Posted by Michael Wonder on 23 Jul 2023
Health Canada approves Trodelvy (sacituzumab govitecan) in pre-treated HR+/HER2- metastatic breast cancer
20 July 2023 - Trodelvy has now improved survival in both pre-treated HR+/HER2- metastatic breast cancer and in second-line metastatic ...
Posted by Michael Wonder on 15 Jun 2023
Health Canada authorises Akeega (niraparib and abiraterone acetate) dual action tablets for targeted treatment of patients with metastatic castration-resistant prostate cancer with BRCA (1/2) gene mutations
14 June 2023 - Approval for Akeega is based on results from the Phase 3 MAGNITUDE study, a prospectively designed precision ...
Posted by Michael Wonder on 31 May 2023
Brukinsa approved in Canada for the treatment of chronic lymphocytic leukaemia
30 May 2023 - BeiGene’s Bruton's tyrosine kinase inhibitor is approved in more than 65 markets globally. ...
Posted by Michael Wonder on 02 May 2023
Libtayo (cemiplimab) in combination with chemotherapy now approved in Canada for the first-line treatment of advanced non-small cell lung cancer
1 May 2023 - Approval marks second first-line indication in NSCLC and fifth indication for Libtayo in Canada. ...
Posted by Michael Wonder on 27 Mar 2023
Kite's Yescarta (axicabtagene ciloleucel) first CAR T-cell therapy to receive Health Canada authorisation for use in second-line large B-cell lymphoma
23 March 2023 - Landmark ZUMA-7 study demonstrated patients on Yescarta were 2.5 times more likely to be alive at ...
Posted by Michael Wonder on 27 Mar 2023
Health Canada authorises Imbruvica (ibrutinib) in a fixed duration combination with venetoclax for adult patients with previously untreated chronic lymphocytic leukaemia
23 March 2023 - All oral, once daily, fixed duration combination regimen authorised for first-line treatment of CLL. ...
Posted by Michael Wonder on 27 Mar 2023
Columvi (glofitamab for injection) receives Health Canada authorisation with conditions for adult patients with relapsed or refractory diffuse large B-cell lymphoma
25 March 2023 - Authorization is based on results from the Phase 1/2 NP30179 study, which demonstrated Columvi induced durable response ...
Posted by Michael Wonder on 13 Jan 2023
Enhertu approved by Health Canada as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
12 January 2023 - Approval based on the DESTINY-Breast04 results which showed Enhertu reduced risk of disease progression or death ...
Posted by Michael Wonder on 25 Nov 2022
Health Canada authorises Polivy (polatuzumab vedotin) for the first-line treatment of adults with large B-cell lymphoma
24 November 2022 - Authorization is based on pivotal data from the Phase 3 POLARIX trial, which met its primary ...
Posted by Michael Wonder on 14 Oct 2022
Health Canada approves Illuccix for prostate cancer imaging
13 October 2022 - Telix Pharmaceuticals announces that Health Canada has approved Illuccix [kit for the preparation of gallium (Ga 68) ...
Posted by Michael Wonder on 13 Oct 2022
Health Canada approves Keytruda (pembrolizumab) as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions
12 October 2022 - Approval based on data from the Phase 3 KEYNOTE-564 trial. ...
Posted by Michael Wonder on 06 Oct 2022
Health Canada approves additional indication for Nubeqa (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer in combination with docetaxel
5 October 2022 - Today's approval was based on the pivotal Phase 3 ARASENS trial, which showed a significant overall survival ...
Posted by Michael Wonder on 14 Sep 2022
Health Canada approves Keytruda (pembrolizumab) as adjuvant treatment for adults and children with stage IIB or IIC melanoma following complete resection
13 September 2022 - Approval is based on the Phase 3 KEYNOTE-716 trial. ...