Shots: The approval is based on the principle of extrapolation of its efficacy data in adults also supported by pharmacokinetic and safety data in children. Additionally, the safety and tolerability data of Brivlera in children 4 years and older were similar to observed in adults The usage of Brivlera in pediatric and adolescent patients is […]Read More
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected […]Read More
Shots: Health Canada has approved Ziextenzo (a biosimilar referencing Neulasta) and Riximyo (a biosimilar referencing Rituxan) for marketing in Canada Sandoz has received Health Canada’s Notice of Compliance on Apr 21, 2020, for the use of Ziextenzo to reduce the incidence of febrile neutropenia while Riximyo has received approval on Apr 28, 2020 to treat […]Read More
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected […]Read More
Shots: The company plans to initiate a P-II RESOLUTION study assessing LAU-7b in multiple hospitals in Canada and will enroll ~200 hospitalized COVID-19 patients for a treatment duration of 14 days and is expected to initiate the enrollment soon The focus of the study is to evaluate LAU-7b’s dual pro-resolving inflammation and antiviral activity against […]Read More
Shots: Nucala (mepolizumab) has received Health Canada’s approval as an add-on maintenance therapy for adolescents & children aged ≥6yrs. with SEA The extension of NUCALA’s indication for adolescents and children aged ≥6yrs. allow the company to bring the therapy to patients and their families with limited treatment options Nucala is the first IL5 biologic to […]Read More
Shots: Health Canada has expanded the approval of Fiasp (10mL vials) to include use in insulin infusion pumps for the improvement of glycemic control in pediatric patients aged ≥2yrs with diabetes (T1D/T2D both) The approval is based on data from 7 clinical studies that verified the safety & efficacy of Fiasp in children. The label […]Read More
Shots: The approval is based on P-III EXPAND study assessing Mayzent vs PBO in 1651 patients with SPMS from 31 countries including 47 participants in Canada with a mean age of 48yrs., living with MS for ~16yrs., >50% had a median EDDS score of 6.0 and relied on a walking aid The P-III EXPAND study result […]Read More
Shots: Health Canada’s marketing authorization transfer of Otezla from Celgene follows Amgen’s acquisition of the global rights of Otezla completed in Nov’2019 The addition of Otezla bolster Amgen’s portfolio of innovative biologics and biosimilar products and complements its expertise in mod. to sev. PsO and active PsA Otezla is a selective PDE4 inhibitor, inhibiting the […]Read More
Shots: The approval follows two P-III studies (COAST V & COAST W) assessing Taltz (q4w) vs PBO in 657 patients with active AS who are bDMARD-naïve & intolerant to TNF inhibitors respectively The P-III studies result: improvement in 1EPs i.e. achievement of ASAS40 @16wks. (48% & 25% vs 18% & 13%); improvement in 2EPs (64% […]Read More
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