TORONTO and CHICAGO and MONTREAL (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (“Medexus” or the “Company”) (TSXV: MDP, OTCQB: PDDPF) today announced that the Company, through its US-based subsidiary, acquired Aptevo BioTherapeutics LLC, a Delaware limited liability company owning the worldwide rights to the commercial hematology asset, IXINITY®, from Aptevo Therapeutics, Inc. (NASDAQ:...Read the Full Article
KIRKLAND, Wash. -- Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), today announced the findings of a post hoc analysis of pooled prospectively collected data from three studies of the Carillon Mitral Contour System® with a focus on 5-year survival...Read the Full Article
RESEARCH TRIANGLE PARK, N.C. (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the fourth quarter and full-year ended December 31, 2019. Related Article: G1 Therapeutics & Quantum Leap Healthcare Collaborate in Breast Cancer Research Study “We achieved significant clinical and...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced the appointment of Max Colao to the newly created position of Chief Commercial Officer. In addition, Aurinia has recruited an experienced team of leaders across...Read the Full Article
TORONTO and CHICAGO and MONTREAL (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) today provided a business update and announced its financial and operating results for the three- and nine-month periods ended December 31, 2019. All dollar amounts below are in Canadian dollars. Related Article: Medexus...Read the Full Article
LISLE, Ill. /PRNewswire/ -- Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), today announced the enrollment of the first two patients in the PROACTIVE-HF pivotal trial. The trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the...Read the Full Article
ATLANTA /PRNewswire/ -- Antios Therapeutics, Inc. ("Antios"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases, today announced it has initiated its first-in-human Phase 1 clinical trial for ATI-2173, a novel liver-targeted, orally-administered, small molecule against hepatitis B. The Phase 1a study is a randomized,...Read the Full Article
Published in December 2019, Frontiers in Oncology, one of the world's top peer-reviewed oncology journals in terms of influence and quality, published a new meta-analysis on the diagnostic value of micro-ultrasound in prostate cancer. Key findings show that micro-ultrasound is a more convenient and cost-effective method in real-time imaging during biopsy procedure...Read the Full Article
SOUTH SAN FRANCISCO, California (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today announced that Phase 1 trial results detailing pharmacokinetics (PK), tolerability, and safety with its lead product candidate, STS101 (DHE (or dihydroergotamine) nasal powder for the acute treatment of migraine), have been published online in the...Read the Full Article
VANCOUVER, British Columbia--(BUSINESS WIRE)-- Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics (“Zymeworks” or the “Company”), announced today the closing of its previously announced underwritten public offering (the “Offering”). The Offering consisted of 5,824,729common shares, including the exercise in full of the underwriters’ over-allotment option to purchase 900,000 additional...Read the Full Article
SEATTLE /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today the commercial launch of the 14-Day version of the Carnation Ambulatory Monitor ("CAM™"), the industry's only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device, following recent clearance by the FDA. "The...Read the Full Article
On January 15, 2020, HistoSonics' research on non-thermal histotripsy tumor ablation was published in the Journal for ImmunoTherapy of Cancer (JITC), the premier cancer immunotherapy journal at BMC and the official journal of the Society for Immunotherapy of Cancer (SITC). An excerpt from the report can be found below. Read the Full...Read the Full Article
VANCOUVER, British Columbia---(BUSINESS WIRE)-- Zymeworks Inc. (NYSE: ZYME) (“Zymeworks” or the “Company”), a clinical‑stage biopharmaceutical company developing multifunctional biotherapeutics, has today filed a preliminary prospectus supplement (the “Canadian Supplement”) to its Canadian short form base shelf prospectus dated November 18, 2019 (the “Base Prospectus”) in connection with an offering of its common...Read the Full Article
SAN FRANCISCO and RESEARCH TRIANGLE PARK, N.C. (GLOBE NEWSWIRE) -- Quantum Leap Healthcare Collaborative™ (QLHC) and G1 Therapeutics, Inc. (Nasdaq: GTHX) announced today a collaboration to evaluate trilaciclib, an investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy, in a new randomized, investigational treatment arm for the ongoing...Read the Full Article
PLYMOUTH, Minn. /PRNewswire/ -- HistoSonics, developer of a novel non-invasive sonic beam therapy platform, was named by The Observer as one of the nation's most influential healthcare companies during the 38th J.P. Morgan Healthcare Investment Conference in San Francisco, CA. The company's platform, Edison, integrates robotics, imaging, and proprietary sensing technology, and uses...Read the Full Article
TEWKSBURY, Mass. /PRNewswire/ -- Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the first Japanese patients were randomized in Toyama and Hyogo under a clinical trial authorization from the Pharmaceutical and Medical Device Agency (PMDA) in the REDUCE LAP-HF II trial. The...Read the Full Article
QUEBEC CITY /CNW Telbec/ - Opsens Inc. ("Opsens" or the "Company") (TSX: OPS) (OTCQX: OPSSF) today announced 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to market its OptoWire III, a coronary pressure guidewire for physiological measurements such as Fractional Flow Reserve ("FFR") and Diastolic Pressure Ratio ("dPR"). The OptoWire III is the latest...Read the Full Article
SEATTLE / PRNewswire / -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor ("CAM™"), the only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device, announced today the appointment of Ed Vertatschitsch as Chief Operating Officer effective January 2, 2020....Read the Full Article
VANCOUVER, British Columbia--(BUSINESS WIRE)-- Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced the initiation of a Phase 2 trial evaluating ZW25 combination therapy and an agreement with Pfizer which advances the study. Zymeworks’ HER2-targeted bispecific antibody ZW25 is being evaluated in combination with Pfizer’s Ibrance® (palbociclib), an...Read the Full Article
BOSTON and MONTRÉAL /PRNewswire/ - enGene Inc., the biotechnology company developing rationally designed gene therapies targeted to mucosal tissues through its proprietary non-viral vector DDX® platform, today announced the appointments of Sharon Tan as Vice President and Head of Program Management, and Lance Dieter as Vice President of CMC and Head of Manufacturing, to further...Read the Full Article
SAN ANTONIO /PRNewswire/ -- Frost & Sullivan, a leading global research and analysis firm, announced that it has awarded HistoSonics its prestigious 2019 North American Technology Innovation Award for the development of the company's new breakthrough platform, designed to destroy solid tumors and diseased tissues without ever entering a patient's body. Related Article:...Read the Full Article
TORONTO, ON / ACCESSWIRE / Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, today announced that it has entered into definitive securities purchase agreements with certain institutional and accredited investors as well as company insiders in a registered direct offering of an aggregate of 1,355,380 common shares. The price per share...Read the Full Article
TORONTO, ON / ACCESSWIRE / December 12, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported financial results for the nine-month period ended September 30, 2019 and provided an update on its business. Edesa recently enrolled the first patient in a Phase 2b clinical study of its lead product...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced the closing of its previously announced underwritten public offering of 12,782,439 common shares, including 1,667,274 common shares pursuant to the full exercise of the underwriters’...Read the Full Article
RESEARCH TRIANGLE PARK, N.C. and SAN ANTONIO (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today reported additional data from the Phase 1b/2a clinical trial investigating its oral CDK4/6 inhibitor lerociclib in combination with fulvestrant for the treatment of estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer. Updated findings presented...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced the pricing of its underwritten public offering of 11,115,165 common shares (the “Offering”). The shares are being sold at a public offering price of US$15.00...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate (“MMF”) and...Read the Full Article
TORONTO, ON / ACCESSWIRE / December 3, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported that the company's lead product candidate, EB01, has demonstrated positive safety data in healthy volunteers participating in its ongoing Phase 2b clinical study in chronic allergic contact dermatitis (ACD), a debilitating disease that is...Read the Full Article
TORONTO – Bright Angel Therapeutics, a biotechnology company focused on developing novel antifungal drugs, today announced an extension to their seed financing round, adding funding that will enable continued advancement of their lead program targeting invasive and drug-resistant fungal infections. Lumira Ventures, Canada's largest and most active healthcare venture capital firm, and Viva...Read the Full Article
TORONTO and CHICAGO and MONTREAL (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) provided a business update and announced its financial and operating results for the three- and six-month periods ended September 30, 2019. All dollar amounts below are in Canadian dollars. Related Article: Medexus Pharmaceuticals Revenues...Read the Full Article
SINGAPORE -- Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced updated Phase 1 data for single-agent ZW25 in heavily pretreated patients with HER2‑expressing solid tumors in a mini oral presentation by Dr. Do-Youn Oh, study investigator and Professor at Seoul National University, at the ESMO Asia 2019...Read the Full Article
LISLE, Ill., Nov. 18, 2019 /PRNewswire/ -- Endotronix Inc., a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), presented positive first-in-human data of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor). Data was presented at the 2019 American Heart Association (AHA) Scientific Sessions in Philadelphia, PA by Prof. Dr. Wilfried...Read the Full Article
VICTORIA, British Columbia -- (BUSINESS WIRE) -- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today reported financial results for the three and nine months ended September 30, 2019 and recent operational highlights. Amounts, unless specified otherwise,...Read the Full Article
QUEBEC CITY, Quebec – Opsens Inc. (“Opsens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF) today reported its results for 2019. Highlights For the Quarter and The Year Record consolidated revenues at $32.8 M for FY2019 compared with $24.1 M for FY2018, a 36% increase;Fractional Flow Reserve (“FFR”) revenues of $20 M for FY2019 compared with $14.2 M for...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced the appointment of Ms. Jill Leversage to its Board of Directors and the resignation of Dr. Hyeuk Joon Lee....Read the Full Article
SOUTH SAN FRANCISCO, Calif., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) a clinical-stage biopharmaceutical company, today reported financial results for the quarter ended September 30, 2019 and provided a business update on recent achievements. “With the successful completion in September of our initial public offering, gross proceeds to...Read the Full Article
Austin, TX, and Montreal, QC (Nov. 8, 2019) – Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, today presented the first Phase 1 clinical data from its oncology development program with AVID200, in a late-breaking poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2019 in...Read the Full Article
QUEBEC CITY, QUEBEC - Opsens Inc. ("Opsens" or the "Company") (TSX:OPS) (OTCQX:OPSSF) today announced the world's first clinical use of the OptoWire III, following the recent Health Canada approval. "This improved version of OptoWire for physiological measurement offers maneuverability and exceptional reliability that significantly simplify the procedure. Assessment of the most complex...Read the Full Article
VICTORIA, British Columbia -- (BUSINESS WIRE) -- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced the completion of a FDA-requested clinical drug-drug interaction (“DDI”) study in patients with lupus that investigated the potential...Read the Full Article
“We recently presented data on our lead asset, ZW25, at two major medical conferences that pave the way for registration-enabling trials in second-line biliary tract cancer (BTC) with single agent ZW25 and in first-line gastroesophageal adenocarcinoma (GEA) with ZW25 in combination with chemotherapy. These clinical plans support our evaluation of ZW25’s broad...Read the Full Article
QUEBEC CITY / CNW Telbec/ -Opsens Inc. ("Opsens" or the "Company") (TSX: OPS) (OTCQX: OPSSF) announces today it is expanding its medical device business into the structural cardiology space and will accelerate development activities of products that reach beyond its current coronary and peripheral applications. "Opsens' technical and commercial capabilities have expanded over the last few years,...Read the Full Article
SOUTH SAN FRANCISCO, Calif. and TORONTO — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, and Notch Therapeutics Inc., an immune cell therapy company creating universally compatible, allogeneic T cell therapies for the treatment of diseases of high unmet...Read the Full Article
RESEARCH TRIANGLE PARK, N.C. (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the third quarter ended September 30, 2019. Review the full filling here. “Based on written feedback from the FDA following our pre-NDA meeting in September, we will submit a New Drug Application for myelopreservation in...Read the Full Article
Toronto, ON, (GLOBE NEWSWIRE) -- Notch Therapeutics, a company in the emerging field of gene-modified T cell therapy, has been created to commercialize a revolutionary technology that creates allogeneic (donor) gene-edited T cells from stem cells on an industrial scale, efficiently making T cell therapies that are clinically robust and of a...Read the Full Article
VICTORIA, British Columbia -- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced the initiation of patient dosing in the Phase 2/3 AUDREY™ clinical trial evaluating voclosporin ophthalmic solution (“VOS”) for the potential...Read the Full Article
BOSTON -- Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announces the first data from its Phase 1 study evaluating novel bispecific antibody ZW25 in combination with chemotherapy in HER2-expressing gastroesophageal adenocarcinoma (GEA) in a poster presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics,...Read the Full Article
SEATTLE /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that it was selected as winner of the "Remote Monitoring in Arrhythmias" Technology and Innovation Pitch Session held as part of the Digital Health program at the European Society of Cardiology (ESC) Congress...Read the Full Article
TORONTO / Accesswire / – Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, today announced that the first patient has been enrolled in a Phase 2b clinical trial evaluating the Company’s lead product candidate, EB01, as a monotherapy for patients with moderate to severe chronic allergic contact dermatitis (ACD). The U.S....Read the Full Article
VANCOUVER, British Columbia — Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced the appointment of Kathryn O’Driscoll to the executive team as Chief People Officer (CPO). Ms. O’Driscoll brings over 20 years of experience as an executive-level human resources leader across large global organizations in the technology...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE) -- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today reported that the last patient study visit has occurred in the AURORA Phase 3 lupus nephritis (“LN”) study. Efficacy and...Read the Full Article