SOUTH SAN FRANCISCO, Calif. -- Satsuma Pharmaceuticals, Inc. ("Satsuma" or the "Company") (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced the closing of the Company's previously announced initial public offering of 5,500,000 shares of common stock at a public offering price of $15.00 per...Read the Full Article
MONTREAL, Sept. 12, 2019 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) announces that Health Quality Ontario, under the guidance of the Ontario Health Technology Advisory Committee, has recommended public funding of Gliolan® (5-aminolevulinic acid hydrochloride) for guiding maximal surgical resection of high-grade gliomas in adults, conditional on...Read the Full Article
Source: Journal of American College of Cardiology: Heart Failure (September 2019) Study Conclusions Yesterday, Cardiac Dimensions met its primary endpoint. Results from the REDUCE FMR clinical study were published in the Journal of American College of Cardiology: Heart Failure. In this first blinded and sham-controlled randomized controlled trial of a percutaneous heart...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 that it has entered into an Open Market Sales Agreement with Jefferies LLC (“Jefferies”) pursuant to which the Company may from time to...Read the Full Article
Corvia Medical is actively enrolling and sponsoring a first-of-its-kind 100+ site, global, Phase 3 clinical trial leveraging continuous multivariate wearable sensor data and artificial intelligence (AI) based analytics to evaluate the clinical efficacy of it's InterAtrial Shunt Device (IASD®) in patients with heart failure. In addition to measuring traditional heart failure endpoints,...Read the Full Article
TORONTO, Sept. 10, 2019 /PRNewswire/ - Exact Imaging, the world's leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, has received CE Mark approval for its Sterile Transperineal Needle Guide for use with Exact Imaging EV29L transducer. Operating on the ExactVu™ micro-ultrasound system, the Sterile Transperineal Needle Guide now...Read the Full Article
SEATTLE, Sept. 6, 2019 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for 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. Developed...Read the Full Article
TORONTO, ON / ACCESSWIRE / September 5, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received approval from Health Canada to begin a clinical study of its investigational drug, EB02, which the company is developing as a potential treatment for patients with grade I-III internal hemorrhoids. Health Canada reviewed Edesa’s...Read the Full Article
SOUTH SAN FRANCISCO, Calif., Sept. 3, 2019 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc. ("Satsuma"), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced that it has commenced an underwritten initial public offering of up to 5,000,000 shares of its common stock. All of the shares...Read the Full Article
TORONTO, ON / ACCESSWIRE / August 14, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported financial results for the three and six months ended June 30, 2019 and provided an update on its business. During the quarter, Edesa completed its reverse acquisition and NASDAQ listing and announced plans to...Read the Full Article
SEATTLE, Aug. 9, 2019 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that HealthTech Arkansas, a healthcare accelerator and investment fund that connects early-stage healthcare companies with disruptive technologies to Arkansas healthcare providers, has selected BardyDx to participate in the organization's 2019 accelerator program. BardyDx was chosen for...Read the Full Article
Related Article: G1 Therapeutics Provides First Quarter 2019 Corporate and Financial Update RESEARCH TRIANGLE PARK, N.C., Aug. 07, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the second quarter ended June 30, 2019. “Our most advanced investigational therapy, trilaciclib, has demonstrated significant benefits for people...Read the Full Article
Related Article: Aurinia Reports First Quarter 2019 Financial Results & Recent Operational Highlights Review condensed consolidated financials here: https://ir.auriniapharma.com/press-releases/detail/153 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...Read the Full Article
Related Article: Zymeworks Reports 2019 First Quarter Results VANCOUVER, British Columbia--(BUSINESS WIRE)-- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today reported financial results for the second quarter ended June 30, 2019. “We had a notable second quarter that included significant activity from our pharmaceutical partners and was highlighted...Read the Full Article
Related Article: Endotronix Receives 13485:2016 certification from the British Standards Institution (BSI) for its Quality Management System LISLE, Ill., Aug. 1, 2019 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced it has received conditional Investigational Device Exemption (IDE) approval from the U.S....Read the Full Article
Related Article: G1 Therapeutics Appoints Garry Nicholson to Chair of the Board of Directors RESEARCH TRIANGLE PARK, N.C., July 30, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced the appointment of Mark Avagliano as Chief Business Officer. In this role, Mr. Avagliano will serve as...Read the Full Article
Related Article: Edesa Receives Approval to Proceed with U.S. Clinical Study TORONTO, ON / ACCESSWIRE / July 25, 2019 / Edesa Biotech, Inc. (NASDAQ: EDSA), a clinical-stage biopharmaceutical company, reported today that the company has completed the manufacturing of its lead drug candidate EB01, a novel sPLA2 inhibitor that Edesa is developing as...Read the Full Article
“It is a pleasure to welcome Max and Glenn to the team at this critical juncture for Aurinia. As we continue to build and expand the organization and prepare for the potential U.S. commercialization of voclosporin, their respective talents complement the team already in place, helping to scale the organization and ensure...Read the Full Article
VANCOUVER, British Columbia--(BUSINESS WIRE) -- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced that its global biopharma partner Celgene Corporation has selected a lead therapeutic candidate in oncology for further development and exercised its option to a commercial license under the companies’ 2014 Azymetric™ collaboration and licensing agreement....Read the Full Article
Study to support European clearance of Cordella™ Pulmonary Artery Sensor System for treatment of patients with chronic heart failure LISLE, IL – Endotronix Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced enrollment of the first patient in its prospective, multi-center, SIRONA II trial,...Read the Full Article
QUEBEC CITY, July 11, 2019 /CNW Telbec/ - Opsens Inc. ("Opsens" or the "Company") (TSX: OPS) (OTCQX: OPSSF) today reported its results for the third quarter of 2019. HIGHLIGHTS Consolidated revenues of $7.9 M for the third quarter of 2019 compared with $6.4 M for the third quarter of 2018, an increase of $1.5 M or 23%;Fractional Flow Reserve ("FFR") sales of $5.2 M for the third quarter...Read the Full Article
– Staccato alprazolam is shown to rapidly suppress seizure activity at two minutes in five patients with epilepsy – – Staccato alprazolam generally well tolerated; no serious or severe adverse events reported – – Enrollment in Phase 2b, double-blind, placebo-controlled study ongoing – SUMMIT, N.J., July 09, 2019 (GLOBE NEWSWIRE) -- Engage...Read the Full Article
TORONTO, CANADA -- Exact Imaging, the world's leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, is the proud recipient of Frost & Sullivan’s 2019 Global Prostate Cancer Diagnostic Imaging Technology Innovation Award. “Exact Imaging’s 29 MHz micro-ultrasound system, ExactVu™, offers a novel approach for targeted real-time...Read the Full Article
Dissident Withdraws the Consents of its Nominees from Consideration Prior to the AGM Aurinia Reaffirms its Commitment to Voclosporin and Creating Shareholder Value VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”) is pleased to announce that shareholders of the Company (the “Shareholders”) elected all eight of...Read the Full Article
MONTREAL, June 25, 2019 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF), a leading specialty pharmaceutical company with a strong North American commercial platform, announces that Adele M. Gulfo has joined the Company's Board of Directors, further enhancing the Board’s commercial and business development expertise. Ken d’Entremont, Chief...Read the Full Article
TORONTO, June 20, 2019 /CNW/ -- Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, reported today that the U.S. Food and Drug Administration has notified the company that it may proceed with its clinical investigation of EB01, a novel sPLA2 inhibitor, which Edesa is developing as a potential treatment for chronic allergic contact dermatitis....Read the Full Article
BardyDx Carnation Ambulatory Monitor (CAM™) - P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection device (Above) SEATTLE, June 19, 2019 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that MedTech Innovator, the premier nonprofit startup accelerator in the medical technology industry, has selected...Read the Full Article
VANCOUVER, British Columbia — Zymeworks Inc. (NYSE/TSX:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics (the “Company”), announced today the pricing of its previously announced underwritten public offering (the “Offering”) of 5,555,556 common shares and, to a certain investor, pre-funded warrants to purchase up to 4,166,690 common shares. The common shares are being...Read the Full Article
- Detailed data from this trial will be presented at a medical meeting later this year - RESEARCH TRIANGLE PARK, N.C., June 18, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced preliminary overall survival (OS) results from a randomized Phase 2 trial which demonstrated that women with metastatic triple-negative...Read the Full Article
- Garry Nicholson to serve as new board chair -- Sir Andrew Witty, Fredric Eshelman, Pharm.D. and prior chair Seth Rudnick, M.D. re-elected - RESEARCH TRIANGLE PARK, N.C., June 13, 2019 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that current board member Garry Nicholson has...Read the Full Article
HistoSonics announced its non-invasive robotics platform and novel sonic beam cancer therapy successfully destroyed 11 tumors in eight patients during its first clinical trial. The results were presented this week at the 2019 Society of Interventional Oncology (SIO) Annual Meeting in Boston. The meeting also included preclinical presentations of what HistoSonics termed...Read the Full Article
SEATTLE, June 6, 2019 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that MedTech Breakthrough, an independent organization that recognizes the top companies and solutions in the global health and medical technology market, has recognized the Carnation Ambulatory Monitor (CAM™) with...Read the Full Article
Dr. Vernon A. Orton, II & Dr. John M. Pettit with colleagues (above)SOURCE: Bellingham Urology Group, PLLC. TORONTO, CANADA -- (June 4, 2019) Exact Imaging, the world's leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced that Bellingham Urology Group has acquired the ExactVu™ micro-ultrasound system...Read the Full Article
SOURCE: Zymeworks VANCOUVER, British Columbia--(BUSINESS WIRE)-- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the appointment of two new independent members to its Board of Directors, further enhancing the Board’s commercial expertise. The new board members are Sue Mahony, Ph.D., MBA, a pharmaceutical executive with over 30...Read the Full Article
SOURCE: G1 Therapeutics G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today presented additional findings from a randomized Phase 2 clinical trial demonstrating the myelopreservation benefits of trilaciclib in patients undergoing chemotherapy treatment for 2nd/3rd-line small cell lung cancer (SCLC). Trilaciclib is a first-in-class myelopreservation agent designed to protect the bone marrow...Read the Full Article
VANCOUVER, British Columbia--(BUSINESS WIRE)-- Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that it has earned a milestone payment from Merck (known as MSD outside the US and Canada) achieved under the companies’ 2014 research and license agreement. Zymeworks will receive US$2.0 million in connection with Merck’s...Read the Full Article
VANCOUVER, British Columbia — Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW25, a novel Azymetric™bispecific antibody, for the first-line treatment of patients with HER2-overexpressing gastroesophageal adenocarcinoma in combination with standard of care...Read the Full Article
Commercial leader brings recent migraine space experience to Satsuma as it advances lead product candidate STS101 into Phase 3 development SOUTH SAN FRANCISCO, Calif., May 29, 2019 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc. ("Satsuma" or "the Company"), a Phase 3-stage biopharmaceutical company developing STS101, (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced...Read the Full Article
Austin, TX and Montreal, QC (May 28, 2019) – Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, announced today that it has obtained approval from Health Canada to conduct Phase 2 clinical trials evaluating AVID100, a novel anti-EGFR antibody-drug conjugate (ADC), in EGFR-overexpressing squamous cell...Read the Full Article
MONTRÉAL and BOSTON, May 29, 2019 -- enGene Inc., the high growth biotechnology company developing the Gene Pill™ - a robust, proprietary non-viral vector platform to deliver gene therapies via oral administration - today announced the appointment of José M. Lora, Ph.D., as Chief Scientific Officer. Dr. Lora will join the executive management team and will be...Read the Full Article
SOURCE: Zymeworks VANCOUVER, British Columbia--(BUSINESS WIRE)--Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that it has entered into a licensing agreement that grants Iconic Therapeutics, Inc. (Iconic) non-exclusive rights to Zymeworks’ proprietary ZymeLink™ antibody-drug conjugate (ADC) platform for the development of its ICON-2 Tissue Factor ADC for...Read the Full Article
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