Tags : canada

Biosimilars

Fresenius Kabi Launches Idacio (biosimilar, adalimumab) for Multiple Chronic Inflammatory

Shots: Health Canada has authorized Idacio on Oct 30, 2020, for marketing in Canada and is now available for all indications of the reference (Humira) in the field of rheumatology, gastroenterology and dermatology Health Canada’s approval was based on analytical, pre/ clinical data that demonstrated similar PK, efficacy, safety and immunogenicity to the Humira. Idacio […]Read More

Biosimilars

Viatris Launches Hulio (biosimilar, adalimumab) in Canada

Shots: Health Canada has approved Hulio, a biosimilar referencing AbbVie’s Humira (adalimumab), which is now available in Canada. It is licensed from Fujifilm Kyowa Kirin and approved for all adalimumab indications The approval was based on an analytical, pre/ clinical program. Fujifilm Kyowa Kirin conducted a P-III ARABESC study that demonstrated no differences in terms […]Read More

Biosimilars

Sandoz Launches Hyrimoz (biosimilar, adalimumab) in Canada

Shots: The company expands its portfolio with the marketing of the 5th biosimilars in Canada. Hyrimoz is indicated for use in nine indications of the reference (Humira) in the field of rheumatology, gastroenterology and dermatology Sandoz Canada has completed the pCPA negotiations for Hyrimoz, which is the first step in securing public reimbursement Hyrimoz is […]Read More

Biosimilars

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada

Shots: Health Canada has authorized Hyrimoz on Nov 4, 2020 for marketing in Canada. Hyrimoz has been approved for use in all same indications as reference Humira, including rheumatology, gastroenterology and dermatology A patient support program will be available to patients treated with Hyrimoz providing guidance with reimbursement navigation, financial assistance, administrative support & education […]Read More

MedTech Regulatory

Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults

Shots: Abbott’s next-generation, sensor-based glucose monitoring technology, FreeStyle Libre 2, received Health Canada’s approval for adults & children with diabetes The system continuously measures glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high/low without scanning The technology sustains performance for ~14days, providing trends, insights & actionable data […]Read More

Pharma

Merck Signs Up to $4.5B Oncology Deal with Seattle Genetics

Shots: Seattle Genetics to receive $600M up front, $1B as equity investment, 5M shares of Seattle Genetics common stock at a price of $200/ share, ~$2.6B as milestones including $850M development milestones and $1.75B as commercial milestones. The companies will equally share costs and profits on the global development of ladiratuzumab vedotin and other LIV-1-targeting […]Read More

Pharma

Takeda Divests its Select Non-Core Assets in the EU and

Shots: Takeda will receive $562M up front for divesting its non-core prescription pharmaceutical products targeting a variety of therapeutic categories sold predominantly in the EU and Canada The divested portfolio includes Takeda’s CV/ metabolic and anti-inflammatory therapeutic areas along with Calcium. The portfolio generated FY 2019 net sales of ~$260M The divestiture further enables Takeda’s […]Read More