SOURCE: Aurinia Pharmaceuticals Inc. VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today reported financial results for the first quarter ended March 31, 2019, and provided an update on recent operational highlights. Amounts, unless specified otherwise, are expressed in U.S. dollars. First Quarter 2019 Highlights...Read the Full Article
SOURCE: Medexus Pharmaceuticals Inc. MONTREAL, May 14, 2019 -- Medexus Pharmaceuticals Inc. (the “Company”) (TSXV: MDP, OTCQB: PDDPF) announced today it has submitted to the TSX Venture Exchange (the “Exchange”) a notice of its intention to make a normal course issuer bid (the “Bid”). Provided the Company receives the approval of the Exchange,...Read the Full Article
Plans to submit U.S. and European marketing applications for trilaciclib following regulatory feedback First clinical data on oral SERD G1T48 expected in 3Q19 Management to host webcast and conference call today at 4:30 p.m. ET RESEARCH TRIANGLE PARK, N.C., May 09, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology...Read the Full Article
This work compares mpMRI with high-resolution 29MHz micro-ultrasound imaging, which maintains the workflow, simplicity and low cost of ultrasound and can be used to target biopsies without the need for MRI. Giovanni Lughezzani (1), Ander Astobieta (2), Frédéric Staerman (3), Eric Klein (4), Robert Abouassaly (4), Ahmed El-Shefai (4), Gregg Eure (5)...Read the Full Article
8 patients with predictable generalized or focal epileptic seizures treated with Staccato alprazolam 62.5% of patients respond with the cessation of seizure activity within two minutes of therapy administration and no recurrence of seizure activity within two hours Feasibility of both self-administration or caregiver-administration demonstrated Enrollment of additional 115 patients in double-blind,...Read the Full Article
VANCOUVER, Canada--(BUSINESS WIRE)-- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, is pleased to announce the detailed voting results on the items of business considered at its Annual General Meeting of Shareholders held on May 2, 2019 (the “Meeting”). Shareholder Voting Results The Shareholders voted on the following matters...Read the Full Article
SOURCE: Medexus Pharmaceuticals Inc. MONTREAL, May 7, 2019 -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF), today announced the launch of a new Metoject® Subcutaneous 15mg dose in Canada. Metoject Subcutaneous is a pre-filled syringe of methotrexate with a pre-attached subcutaneous needle that is approved in Canada for the...Read the Full Article
SEATTLE, May 7, 2019 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced it has been selected as the winner of the North American Remote Cardiac Monitoring Technology Innovation Award by Frost & Sullivan, a leader in global research and consulting solutions. BardyDx earned the distinction...Read the Full Article
SOURCE: Exact Imaging New EV5C Abdominal Transducer and Color Flow and Power Doppler capabilities enable the ExactVu™ micro-ultrasound system to provide a complete men’s health urological imaging solution TORONTO, CANADA -- (May 7, 2019) Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate,...Read the Full Article
Press Release: April 30, 2019 VICTORIA, British Columbia--(BUSINESS WIRE) -- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced it has appointed Dr. Daniel Billen to its Board of Directors. Dr. Billen’s appointment is effective April 29, 2019...Read the Full Article
VANCOUVER, British Columbia--(BUSINESS WIRE) May 2, 2019-- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today reported financial results for the first quarter ended March 31, 2019. “We are pleased to have advanced both of our lead assets to the next stages of clinical development; recently commencing a Phase...Read the Full Article
Micro-Ultrasound and its Significant Clinical Benefits are Featured at the Largest Prostate Cancer Conference in 2 Clinical Talks, 5 Oral Presentations and Clinical Posters and a Skills Symposium CHICAGO, IL -- (May 3, 2019) Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate,...Read the Full Article
SOURCE: OPSENS Inc. QUEBEC CITY, April 30, 2019 /CNW Telbec/ - Opsens Inc. ("Opsens" or the "Company") (TSX: OPS) (OTCQX: OPSSF) is pleased to announce it has entered into a supply agreement as part of its long-term collaboration with Abiomed, Inc. ("Abiomed") for the Impella CP® heart pump. Abiomed has awarded Opsens a five-year...Read the Full Article
VANCOUVER, British Columbia / BUSINESSWIRE/ Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced it has expanded its leadership team with the hiring of three new vice presidents to support the Company’s expanded global clinical development: Mark Hollywood, Senior Vice President, Technical and Manufacturing Operations; Neil Josephson, M.D.,...Read the Full Article
Research Triangle Park, N.C., April 29, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a regulatory update on trilaciclib, a first-in-class myelopreservation agent designed to protect the bone marrow from damage by chemotherapy and improve patient outcomes. Based on written feedback from its end-of-Phase 2...Read the Full Article
SOURCE: Forbius Expansion of ongoing AVID200 Phase 1 solid tumor trial to include patients at clinical sites in CanadaAVID200 is a rationally designed, highly potent inhibitor of TGF-beta 1 & 3, the principal oncogenic TGF-beta isoformsBest-in-class efficacy and safety potential by selectively targeting TGF-beta 1 & 3 while sparing TGF-beta 2, the...Read the Full Article
MANNHEIM, Germany – April 26, 2019 — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments to address functional mitral regurgitation (FMR) in patients with heart failure (HF), presented new data confirming significant reduction in regurgitant volume directly after implantation of the Carillon® Mitral Contour System® at the German...Read the Full Article
Funding supports Phase 3 development of STS101 for the acute treatment of migraine, including pivotal Phase 3 efficacy trial with planned initiation in Q3 2019 SOUTH SAN FRANCISCO, Calif., April 24, 2019 /PRNewswire/ — Satsuma Pharmaceuticals, Inc. (“Satsuma” or “the Company”), a clinical-stage biopharmaceutical company developing STS101, (dihydroergotamine (DHE) nasal powder) for the acute treatment of...Read the Full Article
LISLE, Ill., April 24, 2019 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced that the company received ISO 13485:2016 certification from British Standards Institution (BSI) for its Quality Management System (QMS). Endotronix's adherence to internationally recognized standards for the medical device...Read the Full Article
SOURCE: Forbius Investigator-initiated trial to evaluate AVID200’s safety, anti-fibrotic activity, and ability to restore hematopoiesis in patients with myelofibrosisAVID200 is a rationally designed, highly potent inhibitor of TGF-beta 1 & 3, the principal drivers of fibrosis in myelofibrosis and other fibrotic diseasesAVID200 spares TGF-beta 2, the isoform that promotes hematopoiesis and normal...Read the Full Article
A First-in-Class, Non-Surgical Solution for Obesity Approved for One-Year of Device Treatment, Offering Patients Potentially More Durable Weight Loss and Health Benefits SAN CARLOS, Calif., April 23, 2019 /PRNewswire/ -- BAROnova, Inc., a medical device company focused on the development of first-in-class non-surgical solutions for the treatment of obesity, announced today that the U.S....Read the Full Article
This trial evaluates the efficacy of AVID100 in TNBC patients with EGFR-overexpression20% of TNBC patients highly overexpress EGFR; there is no approved targeted therapyAVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development, targeting both wild-type and mutant forms of EGFR Austin, TX, and Montreal, QC (Apr. 22, 2019) –...Read the Full Article
SEATTLE, April 16, 2019 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it has raised $35.5 million in Series B funding, led by River Cities Capital Funds with participation from new investors HealthQuest Capital, Aperture Venture Partners, Aphelion Capital, Lumira Ventures, and Rex Health Ventures. Existing equity investors, SV Health Investors, Health Enterprise Partners, and Ascension...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE) -- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”), a late clinical-stage biopharmaceutical company focused on the global immunology market, today announced the appointment of Mr. Peter Greenleaf as Chief Executive Officer and as a Director on the Aurinia Board. The Company also announced...Read the Full Article
QUEBEC CITY, April 11, 2019 /CNW Telbec/ - Opsens Inc. ("Opsens" or the "Company") (TSX: OPS) (OTCQX: OPSSF) today reported its results for the second quarter of 2019. HIGHLIGHTS Consolidated revenues totaled $7.9M in the second quarter of 2019 compared with $5.4M in the corresponding period in 2018, an increase of $2.5M or 46%; Fractional Flow Reserve ("FFR") revenues of $4.9M for the second quarter 2019 compared...Read the Full Article
Breakthrough medical platform offers vision of personalized tumor treatments with its novel sonic beam therapy ANN ARBOR, MICHIGAN // Apr. 8, 2019 – HistoSonics, developer of a non-invasive robotics platform and novel beam therapy, announced today that it has closed a $54 million Series C financing. The round was led by Varian...Read the Full Article
https://www.youtube.com/watch?v=zJWcSkfBW4o Video Transcript: Related Article: MAKO Surgical acquired for $1.65 billion by Stryker Corp. “The MAKO Robot is an essential tool that helps us in surgery when we do a joint replacement like total hips and total knees and partial total knees. For us in this area, we're the first ones to...Read the Full Article
SOURCE: Forbius AVID100 is the only clinical-stage anti-EGFR ADC that targets both wild-type and mutant forms of EGFR with limited off-tumor toxicity due to novel mechanism of actionPhase 1 confirmed that AVID100 was well-tolerated and established a recommended phase 2 dose (RP2D) of 220 mg/m2 (~6 mg/kg) q3w, one of the highest amongst...Read the Full Article
https://www.youtube.com/watch?v=tauDDGGvpQU SOURCE: Midas Letter Live March 27, 2019 -- Medexus Pharmaceuticals Inc (CVE:MDP) (FRA:P731) CEO Ken d’Entremont provides an overview of the company and highlights its recent financial reporting. The company is the results of the recent amalgamation of three specialty pharmaceutical companies: Pediapharm Inc, Medexus Inc, and Medac Pharma. As d’Entremont...Read the Full Article
VICTORIA, British Columbia (BUSINESS WIRE) -- In recognition of World Kidney Day and National Kidney Month, Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH/TSX: AUP), a late clinical-stage biopharmaceutical company with research ongoing in two kidney diseases, Lupus Nephritis (LN) and Focal Segmental Glomerulosclerosis (FSGS), today announced a host of activities, including an initiative with...Read the Full Article
1st Spine PMA approved by the FDA in more than 3 years15-month PMA approval process vs. 30-month average for Ortho/Spine in the last 10 years WASHINGTON (PRNewswire) -- On March 7, 2019, MCRA, LLC announced its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA)...Read the Full Article
SUMMIT, N.J. (PRNewswire) -- Engage Therapeutics, Inc., a clinical-stage biopharmaceutical company developing a Rapid Epileptic Seizure Termination (REST) therapy for people who experience a predictable pattern of epileptic seizures, today announced it will present clinical data from the open-label portion of the randomized Phase 2b StATES Study (Staccato Alprazolam Terminates Epileptic Seizures) at the...Read the Full Article
IRVINE, Calif., -- Edwards Lifesciences Corporation EW, -0.99% the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced two strategic transactions involving companies with structural heart disease technologies. Edwards has invested $35 million in an exclusive right to acquire Corvia Medical, Inc., the developer of the...Read the Full Article
LOS ANGELES, March 8, 2019 /CNW/ -- Stellar Biotechnologies, Inc. (Nasdaq: SBOT), a leading manufacturer of a key protein utilized in immunotherapy and immuno-oncology development pipelines, has executed a share exchange agreement with privately-held Edesa Biotech Inc., a Canadian company, and Edesa's shareholders to create a company focused on the development of innovative therapeutics for...Read the Full Article
SOURCE: Forbius This trial will evaluate the efficacy of AVID100 in SCCHN patients with EGFR IHC 3+ tumorsAVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development20% of SCCHN patients highly overexpress EGFR; no therapy is approved for these patients Austin, TX, and Montreal, QC (Mar. 7, 2019) – Forbius,...Read the Full Article
Alan Milinazzo, Partner, Global Healthcare and Life Sciences Practice - Heidrick & Struggles (PRNewsFoto/Heidrick & Struggles) Quebec City, Quebec, March 4, 2019 – Opsens Inc. (“Opsens”) (TSX:OPS) (OTCQX:OPSSF) is pleased to announce the appointment of Mr. Alan Milinazzo as Executive Chairman of the Board of Directors. “We are delighted to see Alan, a renowned leader...Read the Full Article
SOURCE: Forbius This trial will evaluate the safety and anti-fibrotic effects of AVID200 in diffuse cutaneous systemic sclerosis patientsAVID200 is a rationally designed, highly potent inhibitor of TGF-beta 1 & 3TGF-beta 1 & 3 are the principal drivers of fibrosis in systemic sclerosis and other indications, supporting broad utility of AVID200 Austin,...Read the Full Article
Allowed claims cover an individualized flat-dosed pharmacodynamic treatment protocol utilized in the AURA-LV study and the ongoing AURORA study in lupus nephritis Claims have the potential to protect voclosporin’s method of use and dosing protocol for LN until December 2037 VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH/ TSX:AUP) (the “Company” or...Read the Full Article
SOURCE: Forbius MPN-RC sponsored, NIH-supported Phase 1/2 trial in myelofibrosis to commence imminentlyTGF-beta is a central driver of bone marrow fibrosis in myelofibrosisAVID200 selectively inhibits TGF-beta 1 & 3, the principal fibrotic TGF-beta isoforms, while sparing TGF-beta 2, a positive regulator of hematopoiesis Austin, TX and Montreal, QC (Feb. 14, 2019) –...Read the Full Article
VOS showed statistical superiority to Restasis® on FDA-accepted objective signs of DES 42.9% of VOS subjects vs 18.4% of Restasis® subjects (p=.0055) demonstrated ≥ 10mm improvement in STT at Week 4 Primary endpoint of drop discomfort at 1-minute on Day 1 showed no statistical difference between VOS and Restasis®, as both exhibited...Read the Full Article
VANCOUVER, British Columbia — Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today reported the achievement of a new development milestone in its collaboration with Eli Lilly and Company (“Lilly”). In accordance with Zymeworks’ 2014 licensing and collaboration agreement with Lilly, Zymeworks will receive a milestone payment of US$8.0...Read the Full Article
Medical Device Industry Expert to Spearhead European Sales of the Carillon Mitral Contour System KIRKLAND, Wash.--(BUSINESS WIRE)--Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the appointment of Carmelo Mastrandrea as the company’s Vice President of Sales. Mr. Carmelo...Read the Full Article
SOURCE: Forbius AVID200 is a rationally designed and highly potent TGF-beta 1 & 3 inhibitorBest-in-class efficacy and safety potential by selectively targeting principal oncogenic TGF-beta isoformsReverses immunosuppression and renders tumors sensitive to checkpoint blockade in pre-clinical models Jan. 7, 2019 – Forbius, a clinical-stage company developing biologics for the treatment of cancer...Read the Full Article
Veteran Life Sciences Executive Brings Proven Experience Developing CNS Therapeutics MONTREAL and TORONTO, Jan. 4, 2019 /CNW/ - KalGene Pharmaceuticals Inc., a biotechnology company developing therapeutics to slow the progression of Alzheimer's disease, today announced the appointment of James Callaway, Ph.D. as chief executive officer, effective immediately. "This has been a very...Read the Full Article
SOURCE: Endotronix, Inc. LISLE, Ill., Jan. 3, 2019 - Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced that industry veteran Jim Yearick has joined the executive leadership team as Senior Vice President of Sales and Marketing. Mr. Yearick will oversee Endotronix's...Read the Full Article
Trial evaluating safety and efficacy of Staccato Alprazolam in subjects with epilepsy and a predictable seizure pattern Results from the open label portion of the study will be presented at a major medical meeting in 2019 NEW ORLEANS, Dec. 03, 2018 (GLOBE NEWSWIRE) -- Engage Therapeutics today announced from the American Epilepsy...Read the Full Article
International Group of Investors from Canada, the U.S. and China Support Former Senior Executives from Pharmasset and Idenix in New Venture ATLANTA, Nov. 27, 2018 /PRNewswire/ -- Antios Therapeutics, Inc. ("Antios") today announced the completion of a US$25 million oversubscribed Series A financing led by Lumira Ventures and Domain Associates, two prominent...Read the Full Article
Exact Imaging's Novel ExactVu™ Micro-Ultrasound System is Helping Urologists Worldwide Revolutionize Prostate Cancer Detection TORONTO, Nov. 22, 2018 /PRNewswire/ - Exact Imaging, the world's leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, proudly announces this it has been chosen as Life Science Ontario (LSO)'s 2019 Life Science Company of the Year....Read the Full Article
Individuals Treated with TPS lost 3-fold More Weight Than Those in Sham-Controlled Placebo Arm SAN CARLOS, Calif., Nov. 15, 2018 /PRNewswire/ -- BAROnova, Inc., a clinical stage medical device company focused on the development of non-surgical solutions for the treatment of obesity, announced today the presentation of primary results of its pivotal trial,...Read the Full Article
QUEBEC CITY, Nov. 1, 2018 /CNW Telbec/ - Opsens Inc. ("Opsens" or the "Company") (TSX: OPS) (OTCQX: OPSSF) has reached an important milestone with more than 50,000 patients assessed with the OptoWire™, a pressure guidewire used to measure Fractional Flow Reserve ("FFR") to diagnose and treat cardio vascular disease. The use of pressure guidewires to measure...Read the Full Article