Latest news with #HealthCanada
Cision Canada
4 hours ago
- Business
- Cision Canada
Blenrep (belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma Français
Superior efficacy shown in two head-to-head phase III trials, including overall survival in DREAMM-7 Blenrep combinations could redefine treatment as early as first relapse where more effective options are needed 1,2,3 First and only approved anti-BCMA-ADC for the treatment of multiple myeloma in Canada MISSISSAUGA, ON, July 23, 2025 /CNW/ - GSK announced today that Health Canada has approved Blenrep (belantamab mafodotin for injection) in combination with bortezomib and dexamethasone, or in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including lenalidomide for the latter combination. Superior efficacy results, when compared to standard of care, from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support the approval of the Blenrep combinations. These include statistically significant and clinically meaningful progression-free survival (PFS) results versus standards of care in both trials and overall survival (OS) in DREAMM-7. 2, 3,4 The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents. 2, 3 "The approval of Blenrep in Canada represents an advancement for patients with multiple myeloma, a challenging condition marked by repeated cycles of remission and relapse," said Michelle Horn, Country Medical Head, GSK Canada. "As the only BCMA-targeted antibody-drug conjugate, Blenrep has been shown to extend survival and remission, supported by data from the DREAMM-7 and DREAMM-8 phase III clinical trials. This approval marks a milestone in offering a treatment option that holds the promise to transform the therapeutic approach for patients facing their first or subsequent relapses." Blenrep is the first and only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) for multiple myeloma, providing patients facing their first and subsequent relapses with a differentiated mechanism of action. Blenrep combinations can be administered to a broad range of patient types without complex pre-administration regimens or hospitalization. "As patients with multiple myeloma receive combination therapies at diagnosis, the availability of diverse treatment options like Blenrep is vital for prolonging remission and enhancing survival outcomes," said Martine Elias, Chief Executive Officer of Myeloma Canada. "This milestone represents a transformative step forward in the treatment landscape, empowering our community and reinforcing our commitment to making myeloma matter while driving progress toward a cure." In the DREAMM-7 and DREAMM-8 clinical trials, Blenrep combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators. 2, 3 The most common adverse reactions, occurring in ≥20% of patients, were reduced visual acuity (BCVA), corneal examination findings, blurred vision, dry eye, photophobia, foreign body sensation in eyes, eye irritation, eye pain, cataract, upper respiratory tract infection, pneumonia, fatigue, thrombocytopenia, diarrhea, and peripheral sensory neuropathy. Eye-related side effects, a known side effect of treatment with Blenrep, were manageable with extended time between infusions and dose reductions, while maintaining efficacy, and led to low (≤9%) treatment discontinuations in both trials. 2,3 About multiple myeloma Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. 5,6 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year. 7 Multiple myeloma is a significant concern in Canada, where in 2024 alone, 4,000 people were diagnosed with the disease. 8 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. 1 About Blenrep Blenrep is an ADC comprising a humanized BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. In Canada, Blenrep (belantamab mafodotin for injection) is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. Specifically, Blenrep is indicated: in combination with bortezomib and dexamethasone (BVd), in adult patients who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone (BPd), in adult patients who have received at least one prior line of therapy, including lenalidomide. Please consult the Product Monograph at for complete safety information. The Product Monograph is also available by calling 1-800-387-7374. About DREAMM-7 DREAMM-7 is a multicentre, open-label, randomized phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in adult patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy. The trial enrolled 494 participants who were randomized 1:1 to receive either BVd or DVd for eight cycles, after which patients received belantamab mafodotin or daratumumab as a monotherapy. The primary endpoint was PFS as per an independent review committee, with secondary endpoints including OS, duration of response (DOR), and minimal residual disease (MRD) negativity. Other secondary endpoints include overall response rate (ORR), safety, and patient-reported quality-of-life outcomes. The Blenrep combination demonstrated a statistically significant and clinically meaningful improvement in PFS. The median PFS was 36.6 months (95% CI: 28.4-not reached [NR]) with BVd compared to 13.4 months (11.1-17.5) with DVd (hazard ratio for disease progression or death, 0.41; 95% CI, 0.31 to 0.53; P<0.001). For Overall Survival (OS), at the first pre-planned interim analysis, the hazard ratio was 0.57; 95% CI, 0.40, 0.80, indicating a 43% reduction in the risk of death in favour of BVd. More recently, the updated OS results were statistically significant and maintained the reduction in the risk of death in favour of BVd. These results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2024. 2,4 These findings were consistently observed in subgroups and supported by secondary endpoints. About DREAMM-8 DREAMM-8 is a multicentre, open-label, randomized phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in adult patients with relapsed/refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen. The trial included 302 participants who were randomized 1:1 to receive either BPd or PVd. Patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 81% were refractory to lenalidomide, 25% had prior anti-CD38 exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and then 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient-reported quality-of-life outcomes. In DREAMM-8, the Blenrep combination demonstrated a statistically significant and clinically meaningful improvement in PFS, with a 48% reduction in the risk of disease progression or death compared to PVd (HR: 0.52 [95% CI: 0.37-0.73], p-value<0.001). At the primary analysis, with a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with BPd compared to 12.7 months (95% CI: 9.1-18.5) for PVd. Recently, in an updated interim analysis, after a median follow-up of 28.01 months, the mPFS in the BPd arm was 32.6 months compared with 12.5 months in the PVd arm. These results were presented at the European Hematology Association (EHA) Annual Meeting in June 2025. 9 The clinical benefit for BPd was observed across all pre-specified subgroups including those with poor prognostic features, such as patients who were refractory to lenalidomide and patients with high-risk cytogenetics. GSK in Oncology Our ambition in oncology is to help increase overall quality of life, maximise survival, and change the course of disease, expanding from our current focus on blood and women's cancers into lung and gastrointestinal cancers, as well as other solid tumours. This includes accelerating priority programmes such as antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly selective KIT tyrosine kinase inhibitor. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q1 Results for 2025. SOURCE GlaxoSmithKline Inc.
Malaysian Reserve
a day ago
- Health
- Malaysian Reserve
Vertex Announces Marketing Authorization in Canada for ALYFTREK, a Once-Daily Next-Generation CFTR Modulator for the Treatment of Cystic Fibrosis
– In head-to-head clinical trials, ALYFTREK was non-inferior on ppFEV1 and superior in reducing sweat chloride compared to TRIKAFTA – – Approximately 3,800 people in Canada are now eligible for ALYFTREK, with up to 60 people potentially eligible for a medicine that treats the underlying cause of their disease for the first time – TORONTO, July 22, 2025 /CNW/ – Vertex Pharmaceuticals today announced that Health Canada has granted Marketing Authorization for PrALYFTREKTM (vanzacaftor/tezacaftor/deutivacaftor), a new triple combination therapy for patients living with cystic fibrosis (CF) ages 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. ALYFTREK brings a potentially transformative therapy to up to 60 people living with CF in Canada who were not previously eligible for a CFTR modulator. As the first once-daily CFTR modulator, ALYFTREK may also provide a new treatment option and flexibility for approximately 3,800 people given the need to take CFTR modulators with fat-containing food. 'ALYFTREK represents the next generation of CFTR modulator treatment and is a testament to our long-standing goal to address the underlying cause of cystic fibrosis, treat more people living with CF, and bring more people to normal levels of CFTR function,' said Michael Siauw, General Manager at Vertex Pharmaceuticals (Canada) Incorporated. 'With once-daily dosing, eligibility in 113 additional mutations, and the potential to lower sweat chloride levels even further, ALYFTREK brings us one step closer to achieving this goal.' This approval is based on a comprehensive Phase 3 pivotal program, including more than 1,000 patients across more than 20 countries and more than 200 sites. The Phase 3 studies in people with CF ages 12 years and older met their primary endpoint (non-inferiority on absolute change from baseline in ppFEV1 compared to TRIKAFTA) and all key secondary endpoints (including absolute change from baseline in sweat chloride [SwCl] compared to TRIKAFTA). In the Phase 3 study of children with CF ages 6-11 years, ALYFTREK demonstrated safety, the primary endpoint. Secondary endpoints, such as absolute change from baseline in ppFEV1 and absolute change from baseline in SwCl, demonstrate the benefit of ALYFTREK in this age group. ALYFTREK was generally well tolerated across all studies. 'For Canadian patients and families, the approval of ALYFTREK represents significant progress towards improved care,' said Dr. Bradley Quon, Medical and Research Director of the Adult Cystic Fibrosis Program at St. Paul's Hospital, and Associate Professor of Medicine in the Faculty of Medicine at the University of British Columbia. 'Lower levels of sweat chloride combined with the convenience of a once-a-day treatment provides a new option that has the potential to both improve CFTR function and reduce treatment burden.' ALYFTREK is currently approved in the U.S., UK and European Union and is under regulatory review in Switzerland, Australia and New Zealand. About Cystic Fibrosis Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 109,000 people, including 94,000 people in North America, Europe and Australia. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the 30s, but with treatment, projected survival is improving. Today Vertex CF medicines are treating over 75,000 people with CF in more than 60 countries on six continents. This represents 2/3 of the diagnosed people with CF eligible for CFTR modulator therapy. Sweat chloride, which measures CFTR function, is used to diagnose CF. The diagnostic threshold for CF is SwCl ≥60 mmol/L, while levels between 30-59 indicate CF is possible and more testing may be needed to make the diagnosis of CF. A SwCl level of <30 mmol/L is seen in people who carry one copy of a CFTR gene mutation but do not have any manifestation of disease (carriers). At a population level, higher levels of SwCl are associated with more severe disease. Restoring CFTR function leads to lower levels of SwCl. Restoring SwCl levels below 30 mmol/L has long been the ultimate treatment goal for Vertex, as levels below 30 mmol/L are considered normal and are typical of CF carriers who do not have disease. About ALYFTREKTM (vanzacaftor/tezacaftor/deutivacaftor) In people with CF, mutations in the CFTR gene lead to decreased quantity and/or function of the CFTR protein channel at the cell surface. Vanzacaftor and tezacaftor are designed to increase the amount of CFTR protein at the cell surface by facilitating the processing and trafficking of the CFTR protein. Deutivacaftor is a potentiator designed to increase the channel open probability of the CFTR protein delivered to the cell surface to improve the flow of salt and water across the cell membrane. ALYFTREK is approved in the U.S., UK, and Canada for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene. ALYFTREK is approved in the European Union for the treatment of CF in patients ages 6 years and older who have at least one non-class I mutation in the CFTR gene. Boxed Warning Elevated transaminases have been observed in some patients treated with ALYFTREK. Cases of liver failure leading to transplantation and death have been reported in patients with and without a history of liver disease taking a fixed dose combination drug containing elexacaftor, tezacaftor, and ivacaftor, which contains one same (tezacaftor) and one similar (ivacaftor) active ingredient as ALYFTREK. Liver injury has primarily been reported within the first 6 months following initiation of elexacaftor/tezacaftor/ivacaftor. See full ALYFTREK Product Monograph for further details. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 15 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Michael Siauw and Dr. Bradley Quon, and statements regarding the anticipated eligible patient population in Canada and expectations for the ALYFTREK regulatory submissions in Switzerland, Australia and New Zealand. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy, or other reasons, and other risks listed under the heading 'Risk Factors' in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at and available through the company's website at You should not place undue reliance on these statements or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN) Vertex Pharmaceuticals IncorporatedInvestors:InvestorInfo@ Media: mediainfo@ +1 647-790-1600
Cision Canada
a day ago
- Health
- Cision Canada
Vertex Announces Marketing Authorization in Canada for ALYFTREK, a Once-Daily Next-Generation CFTR Modulator for the Treatment of Cystic Fibrosis
- Approximately 3,800 people in Canada are now eligible for ALYFTREK, with up to 60 people potentially eligible for a medicine that treats the underlying cause of their disease for the first time - TORONTO, July 22, 2025 /CNW/ - Vertex Pharmaceuticals today announced that Health Canada has granted Marketing Authorization for Pr ALYFTREK TM (vanzacaftor/tezacaftor/deutivacaftor), a new triple combination therapy for patients living with cystic fibrosis (CF) ages 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. ALYFTREK brings a potentially transformative therapy to up to 60 people living with CF in Canada who were not previously eligible for a CFTR modulator. As the first once-daily CFTR modulator, ALYFTREK may also provide a new treatment option and flexibility for approximately 3,800 people given the need to take CFTR modulators with fat-containing food. "ALYFTREK represents the next generation of CFTR modulator treatment and is a testament to our long-standing goal to address the underlying cause of cystic fibrosis, treat more people living with CF, and bring more people to normal levels of CFTR function," said Michael Siauw, General Manager at Vertex Pharmaceuticals (Canada) Incorporated. "With once-daily dosing, eligibility in 113 additional mutations, and the potential to lower sweat chloride levels even further, ALYFTREK brings us one step closer to achieving this goal." This approval is based on a comprehensive Phase 3 pivotal program, including more than 1,000 patients across more than 20 countries and more than 200 sites. The Phase 3 studies in people with CF ages 12 years and older met their primary endpoint (non-inferiority on absolute change from baseline in ppFEV 1 compared to TRIKAFTA) and all key secondary endpoints (including absolute change from baseline in sweat chloride [SwCl] compared to TRIKAFTA). In the Phase 3 study of children with CF ages 6-11 years, ALYFTREK demonstrated safety, the primary endpoint. Secondary endpoints, such as absolute change from baseline in ppFEV 1 and absolute change from baseline in SwCl, demonstrate the benefit of ALYFTREK in this age group. ALYFTREK was generally well tolerated across all studies. "For Canadian patients and families, the approval of ALYFTREK represents significant progress towards improved care," said Dr. Bradley Quon, Medical and Research Director of the Adult Cystic Fibrosis Program at St. Paul's Hospital, and Associate Professor of Medicine in the Faculty of Medicine at the University of British Columbia. "Lower levels of sweat chloride combined with the convenience of a once-a-day treatment provides a new option that has the potential to both improve CFTR function and reduce treatment burden." ALYFTREK is currently approved in the U.S., UK and European Union and is under regulatory review in Switzerland, Australia and New Zealand. About Cystic Fibrosis Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 109,000 people, including 94,000 people in North America, Europe and Australia. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the 30s, but with treatment, projected survival is improving. Today Vertex CF medicines are treating over 75,000 people with CF in more than 60 countries on six continents. This represents 2/3 of the diagnosed people with CF eligible for CFTR modulator therapy. Sweat chloride, which measures CFTR function, is used to diagnose CF. The diagnostic threshold for CF is SwCl ≥60 mmol/L, while levels between 30-59 indicate CF is possible and more testing may be needed to make the diagnosis of CF. A SwCl level of <30 mmol/L is seen in people who carry one copy of a CFTR gene mutation but do not have any manifestation of disease (carriers). At a population level, higher levels of SwCl are associated with more severe disease. Restoring CFTR function leads to lower levels of SwCl. Restoring SwCl levels below 30 mmol/L has long been the ultimate treatment goal for Vertex, as levels below 30 mmol/L are considered normal and are typical of CF carriers who do not have disease. About ALYFTREK TM (vanzacaftor/tezacaftor/deutivacaftor) In people with CF, mutations in the CFTR gene lead to decreased quantity and/or function of the CFTR protein channel at the cell surface. Vanzacaftor and tezacaftor are designed to increase the amount of CFTR protein at the cell surface by facilitating the processing and trafficking of the CFTR protein. Deutivacaftor is a potentiator designed to increase the channel open probability of the CFTR protein delivered to the cell surface to improve the flow of salt and water across the cell membrane. ALYFTREK is approved in the U.S., UK, and Canada for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene. ALYFTREK is approved in the European Union for the treatment of CF in patients ages 6 years and older who have at least one non-class I mutation in the CFTR gene. Boxed Warning Elevated transaminases have been observed in some patients treated with ALYFTREK. Cases of liver failure leading to transplantation and death have been reported in patients with and without a history of liver disease taking a fixed dose combination drug containing elexacaftor, tezacaftor, and ivacaftor, which contains one same (tezacaftor) and one similar (ivacaftor) active ingredient as ALYFTREK. Liver injury has primarily been reported within the first 6 months following initiation of elexacaftor/tezacaftor/ivacaftor. See full ALYFTREK Product Monograph for further details. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 15 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Michael Siauw and Dr. Bradley Quon, and statements regarding the anticipated eligible patient population in Canada and expectations for the ALYFTREK regulatory submissions in Switzerland, Australia and New Zealand. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy, or other reasons, and other risks listed under the heading "Risk Factors" in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at and available through the company's website at You should not place undue reliance on these statements or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN) Vertex Pharmaceuticals Incorporated Investors: [email protected] Media: [email protected] or Canada: +1 647-790-1600 SOURCE Vertex Pharmaceuticals (Canada) Inc.
Edmonton Journal
a day ago
- Politics
- Edmonton Journal
Jamie Sarkonak: Nanaimo, where complaining about feces-drenched drug zones is all you can do
RCMP Constable Adam Taylor explained to the finance committee that the force is held back by federal rules that allow the possession of up to 2.5 grams of illegal drugs, which prevent them from making arrests. (Federal decriminalization efforts have caused similar front-line problems in Sarnia, Ont., to the great frustration of locals). Article content 'Our stance right now is if they are using it in public and it's not grossly over (the federal exemption), it's what we call a 'no case seizure,'' Taylor explained. 'They are arrested, we search them, we seize the drugs, and if it's a small amount, it's just sent with a request to Health Canada to have them destroyed.' Article content To that, Nanaimo Mayor Leonard Krog asked: 'Is it fair to say … (that) it is practically speaking impossible for the police to arrest folks in a meaningful way for drug use in a public place?' Article content Article content The officer's reply? 'Yes.' Article content The centre, as with many others of its type, does help people. It houses the homeless overnight, and, anecdotally, the city reports that it's connected some individuals with addiction treatment. But, to accomplish all this, it's transformed the surrounding area into a free-range homeless zone rooted to a few indoor service providers. Article content As for whether any of this is improving overdose statistics long-term, it's not optimistic: Nanaimo's rate tripled from 500 in 2016 to 1,500 in 2024, according to provincial data. It's true that 2024 was better than 2023, which saw 2,500 deaths, but plenty more progress needs to be made before the city can declare victory. Article content Similar stories of urban devastation crop up across the country. In Sarnia, in Hamilton, Ont. and in Kitchener, Ont., homeless encampments have become court-entrenched features, with judges ruling that insufficient shelter space renders camp-clearing a Charter violation — with no thought for the general public, of course. In Vancouver, the scene is so bad that Crown prosecutors, whose offices are located in the midst of the maelstrom, are begging to move. Article content Article content In Nanaimo, authorities are now considering moving the Hub in light of resident feedback, but the city's social planning manager wasn't optimistic that a new location could be found. Of course, simply closing the thing isn't an option — it never is. Article content That's Canada, 2025: instead of arresting the people whose crime and chaos destroy community for everyone else, or at least isolating them in facilities for people who can't take care of themselves (which the homeless and addicted can't), we shrug. Whether their problems surface before city councils or courts, the well-being of everyday, society-contributing, city residents remains a low priority.
Yahoo
a day ago
- Business
- Yahoo
Alcon's Latest Breakthrough Surgical Technology, Unity VCS, receives Health Canada approval
Combined vitreoretinal-cataract system (VCS) is cleared for use in Canada New, proprietary technology is designed to deliver significant surgical and workflow efficiencies First innovation to be introduced from Alcon's cutting-edge Unity portfolio of surgical equipment TORONTO, July 08, 2025--(BUSINESS WIRE)--Alcon, the global leader in eye care dedicated to helping people see brilliantly, today announced that UNITY® Vitreoretinal Cataract System (VCS) has received Health Canada approval. This innovation is the first to be introduced from Alcon's highly anticipated Unity portfolio. "Today marks an important day for Canadian ophthalmologists as we introduce the next generation of equipment solutions in cataract and vitreoretinal surgery, and we are grateful to those who helped us reach this milestone," said Franck Leveiller, Head of Global R&D and Chief Scientific Officer, Alcon. "We have a long legacy of engaging our customers throughout the research and development process to design bold innovations in ophthalmology. This approval is a significant milestone in delivering meaningful impact for Canadian Eye Care Professionals and patients." Unity VCS is Alcon's most advanced vitreoretinal and cataract surgical innovations combined together in one integrated platform. Unity VCS is designed to deliver enhanced workflow efficiencies over Alcon's current leading systems, CONSTELLATION® Vision System for vitreoretinal and combined procedures, and CENTURION® Vision System with ACTIVE SENTRY® for cataract surgery. "The first time I used Unity VCS in a wet lab environment, I had a real 'wow' reaction," said Dr. Rosa Braga-Mele, ophthalmologist and chair of Alcon's North America Cataract Core Advisory Board. "This is a proud moment to see the world-class innovation from Alcon receive approval in Canada. I'm particularly excited about the stability of the fluidics and cutting efficiency of the platform, which is quite remarkable and will create considerable surgical efficiencies." Unity VCS leverages a novel phacoemulsification modality to deliver up to two times faster nucleus removal^ with 40% less energy* into the eye1, and a first-of-its-kind phaco handpiece that estimates temperature at the incision site3. In vitreoretinal advancements, the new technology offers cutting speeds of up to 30,000 cuts per minute, the world's fastest vitrectomy probe#,2,3. The platform offers surgical stability and efficiency with a unique proprietary fluidics system3. "As a global market leader in cataract and retina surgical products4,5,6, Alcon recognizes that the increasing demand for these procedures7,8,9 necessitates enhanced workflow efficiencies and excellent patient outcomes," said Jeroen Bastemeijer, General Manager, Alcon Canada. "Unity VCS builds on Alcon's expertise in surgical equipment with pioneering innovations for vitreoretinal and cataract surgery—driving advancements from cutting speeds to fluidics management, to ergonomics and workflow. We are thrilled to bring this latest breakthrough technology, Unity VCS, to Canadian clinics in 2026." Alcon has tested Unity VCS during investigational advisory wet lab sessions with more than 200 highly experienced surgeons from 30+ countries. Commercial launch of Unity VCS is expected in early 2026. Unity VCS is the latest innovation from the Alcon Vision Suite—a portfolio of innovative products designed to help Eye Care Professionals increase clinic and OR efficiency, and deliver exceptional patient experiences. The Alcon Vision Suite will continue to grow with cutting-edge Unity products that are expected to be introduced over the coming years, adding to our market-leading legacy products, which will continue to be available and serviceable. Unity VCS will be supported by Alcon's training, product maintenance, and Services teams. About AlconAlcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people's lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at About UNITY VCSIndications / Intended Use3: The UNITY® VCS (Vitreoretinal Cataract System) console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, with the optional laser, this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy and trabeculoplasty procedures. Please refer to the Directions for Use for the accessories/consumables and User Manual for a complete listing of indications, warnings, cautions and notes. ^2x faster nucleus removal than OZIL Torsional phaco*Based on N=10 HPs, Artificial cataract lens IOP 55 mmHg vacuum of 450 mmHg#Compared to Constellation HYPERVIT 20k vitrectomy probeOZIL - Trademarks are the property of their respective owners. References Alcon Data on File, 2024 - REF-24379. Alcon Data on File, 2024 - REF-24644. Unity VCS User Manual 2024 – REF-24980. Market Scope 2023 Retinal Surgical Device Market Report, 2023. Market Scope 2023 Cataract Surgical Equipment Market Report, 2023. Market Scope 2024 IOL Market Report, 2024. CNIB – Blindness in Canada, Accessed December 2, 2024 - REF-19527. The Prevalence of Canadian Vision Loss and Cataract Surgery, 2019 - REF-01661. Conference Board of Canada - Ophthalmology in Canada: Why Vision Loss Should Not Be Overlooked, 2020 - REF-10834. Connect with us onFacebook LinkedIn View source version on Contacts Media Relations Jane Lee Cheung+1 289 290 2393 (Canada)
