GE Healthcare will incorporate Imeka's neuroimaging technology into BrainWave MRI to provide additional insights into central nervous system diseases and disorders
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Following the positive outcome of a meeting with the FDA, a first patient was recruited in the Phase 3 expansion of the RESOLUTION study with LAU-7b in hospitalized moderate-to-severe COVID-19 patients
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Immune Biosolutions Inc., a clinical-stage company, is pleased to announce that its leading biological drug candidate maintains a potent activity in neutralization assays. Recent results have confirmed that this drug, IBIO123, is capable of neutralizing SARS-CoV-2 (COVID-19) and all its current variants of concern (VOCs) that have emerged throughout the pandemic, including the latest Omicron variant. IBIO123 is an inhaled antibody-based immunotherapy with an ongoing multisite phase 1 and 2 clinical program for the treatment of symptomatic SARS-CoV-2 patients.
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MONTREAL--(BUSINESS WIRE)--Laurent Pharmaceuticals Inc., a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (“FDA”) has allowed the Phase 2 RESOLUTION study extension in hospitalized moderate-to-severe adult COVID-19 patients and the change of the primary endpoint to “proportion of patients requiring mechanical ventilation and/or death by Day 60.” The company also announced that the FDA has granted a Type B meeting request to discuss, among other topics, the eligibility to Emergency Use Authorization (EUA) and Phase 3 clinical trials with LAU-7b in COVID-19, in both hospitalized and ambulatory settings. The meeting will take place on January 14th, 2022, via conference call.
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This Japanese study, in combination with final data from the global Phase 2/3 study of the vaccine candidate, will be used to support an application for regulatory approval in Japan by March of 2022.
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Life science stakeholders, in particular, can play a central role in addressing current challenges, while delivering significant economic benefits including investment and jobs.
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Molecular Forecaster Inc. (MFI) is excited to announce it has secured funding to further develop its structure-based drug-design software, offer its research services, and expand into new niche drug targets.
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Laurent Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing LAU-7b, a first-in-class pro-resolving drug candidate, reported today topline results from its Phase 2 RESOLUTION clinical trial in hospitalized COVID-19 patients.
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LAVAL, QC, June 30, 2021 /CNW Telbec/ - A few weeks after announcing the availability of its Elecsys® Anti-SARS-CoV-2-S (spike protein) antibody test, Roche Diagnostics, a division of Hoffmann-La Roche Limited, is pleased to announce that its SARS-CoV-2 Rapid Antigen Test Nasal, commercialized under a Global partnership with SD Biosensor Inc., has received approval under Health Canada's Interim Order, increasing Roche's contribution to the fight against the pandemic.
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Laurent Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing the first-in-class pro-resolving drug LAU-7b, today announces that it has completed the enrollment for its placebo-controlled Phase 2 RESOLUTION clinical study of hospitalized patients with COVID-19. The study, which enrolled 240 patients across Canada and United States, is expected to report top-line results in Q3 2021.
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QUEBEC CITY, April 23, 2021 /CNW Telbec/ - Medicago, a biopharmaceutical company headquartered in Quebec City is pleased to announce that Health Canada received for review the first portion of Medicago's plant-derived adjuvanted COVID-19 vaccine candidate rolling submission on April 19, 2021.
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The COVID-19 pandemic has underlined the essential role of the biotechnology sector. Québec has a wealth of talented researchers and entrepreneurs in several specialties, including neurology, oncology, rare diseases and cardiology. And investors in the province believe that the life sciences will play a major economic role in the post-coronavirus era.
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TORONTO, April 16, 2021 /CNW/ - On April 8, 2021, Eli Lilly and Company and Incyte announced the results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4mg once daily plus standard of care (SoC) versus placebo plus SoC. The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. Baricitinib-treated patients were 2.7 per cent less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; p=0.1800).
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MONTREAL, April 8, 2021 /CNW Telbec/ - Laurent Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing first-in-class pro-resolving drug LAU-7b, today announces that the independent Data Safety Monitoring Board (DSMB) for the Phase 2 RESOLUTION study in hospitalized patients with COVID-19 unanimously recommended to continue the study without modification following a pre-scheduled safety review and mid-study interim futility analysis of unblinded efficacy data from the first 102 patients treated in the study. The company also reports the completion of enrollment in its Phase 2 APPLAUD study in adult patients with Cystic Fibrosis (CF).
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QUEBEC CITY and AUSTIN, Texas, March 24, 2021 /CNW Telbec/ - Dr Louis-Philippe Vézina CEO of Angany, and Mr. Bill Brydges, CEO of Phylloceuticals announce today that the two companies will team up to accelerate the development of a preventive and curative product based on neutralizing monoclonal antibodies (NAbs) against SARS CoV-02 and its variants.
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QUEBEC CITY and LONDON, March 16, 2021 /CNW/ - Medicago, a biopharmaceutical company headquartered in Quebec City and GlaxoSmithKline (GSK), are pleased to announce the start of Phase 3 clinical testing of Medicago's plant-derived COVID-19 vaccine candidate in combination with GSK's pandemic adjuvant, as part of the ongoing Phase 2/3 study. Medicago received approval from Canadian and US regulatory authorities to proceed with enrollment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. In parallel, Medicago has also initiated a feasibility study of a vaccine candidate to address the emerging COVID-19 variants.
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SHERBROOKE, Québec (March 16, 2021)—Immune Biosolutions, an innovative biotechnology company, receives $13.44M from the Government of Canada’s Strategic Innovation Fund (SIF) to develop its promising immunotherapy whose antibodies have the potential to neutralize and eliminate COVID-19 and its variants.
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OTTAWA, ON, March 16, 2021 /CNW/ - Canadians have demonstrated a remarkable ability to mobilize in response to the COVID–19 pandemic. Companies in the biomanufacturing space from coast to coast to coast have answered the call, and the government wants to recognize their work. To date, the Government of Canada has made investments of approximately $1 billion to advance industrial research and development in vaccines and pharmaceuticals, as well as biomanufacturing capacity. We will continue to partner with Canadian industry and businesses to protect Canadians from COVID-19 while building new biomanufacturing capacity as part of our recovery plan.
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TORONTO, March 15, 2021 /CNW/ - Eli Lilly and Company recently announced new data from the randomized, double-blind, placebo-controlled BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths ("events") in high-risk patients recently diagnosed with COVID-19. These results provide additional efficacy and safety data that support the use of the dose recently granted both Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).
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