MINNEAPOLIS, Sept. 9, 2020 /PRNewswire/ -- HistoSonics, developer of the non-invasive Edison platform and novel sonic beam therapy, announced today the appointment of Joe Amaral, MD, to the newly created position of Vice President of Medical Affairs, where he will oversee global clinical development initiatives for the company. Dr. Amaral brings with him more than 35...Read the Full Article
SEATTLE, Sept. 8, 2020 /PRNewswire/ -- Bardy Diagnostics, Inc., ("BardyDx"), a leading developer and provider of remote ambulatory cardiac monitoring and digital health solutions, announced today the appointment of Kevin Hykes as President and Chief Executive Officer, effective August 31, 2020. Hykes will also become a member of BardyDx's Board of Directors. With over 28 years of...Read the Full Article
ATLANTA, Sept. 1, 2020 /PRNewswire/ -- Antios Therapeutics, Inc. ("Antios"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases, announced today the publication of preclinical results of ATI-2173, Antios' lead oral drug candidate for treating patients infected with Hepatitis B virus (HBV). The manuscript, published in...Read the Full Article
Forbius’s Lead TGF-beta Asset, AVID200, is an Isoform-Selective TGF-beta Inhibitor, Currently in Phase 1 for Oncology and Fibrosis NEW YORK & MONTREAL-- Bristol Myers Squibb (NYSE: BMY) and Forbius, a privately held, clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases, today announced that...Read the Full Article
- PDUFA action date of February 15, 2021 assigned by U.S. Food and Drug Administration- Priority Review for trilaciclib is based on positive data from three randomized clinical trials showing robust myelopreservation benefits- G1 launching expanded access program (EAP) for patients with small cell lung cancer in the U.S. RESEARCH TRIANGLE PARK,...Read the Full Article
ASCEND results expected to support STS101 NDA filing in Q4 2021 SOUTH SAN FRANCISCO, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today announced the initiation of patient enrollment in the ASCEND trial, a multi-center, open-label, 12-month study to evaluate the safety and tolerability...Read the Full Article
Breakthrough medical platform offers vision of non-invasive procedures to eliminate diseased tissues and tumors MINNEAPOLIS, June 8, 2020 /PRNewswire/ -- HistoSonics, developer of a non-invasive robotic platform and sonic beam therapy, announced today that it has closed $40 million in an oversubscribed Series C-1 financing. The round was led by Yonjin Venture, LLC,...Read the Full Article
- Staccato® Alprazolam could be a potential solution for 20-30% of epilepsy patients - Initial upfront payment of US$ 125 million and further potential milestone payments of up to US$ 145 million, total potential consideration of up to US$ 270 million. - Underlines UCB's leadership in epilepsy by adding Staccato® Alprazolam, a...Read the Full Article
Initial results demonstrate anti-fibrotic effects of AVID200 as indicated by rapid and sustained declines in skin fibrosis.AVID200 was well-tolerated, and no dose-limiting toxicities, SAEs or adverse events greater than Grade 2 were observed. The MTD was not reached.AVID200 demonstrated pharmacodynamic responses as shown by modulation of downstream targets of TGF-beta and biomarkers...Read the Full Article
DARTMOUTH, Nova Scotia--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company, today announced its intention to complete a private placement (the “Private Placement”) of 7,797,203 units of the Company (each, a “Unit”) at the market price of Cdn$2.86 per Unit based on the volume-weighted average price calculated over the...Read the Full Article
TORONTO, ON / ACCESSWIRE / April 20, 2020 / Edesa Biotech, Inc. (EDSA), a clinical-stage biopharmaceutical company, today announced a strategic agreement with Light Chain Bioscience (a brand of NovImmune SA), a leading Swiss pharmaceutical development company, for an exclusive worldwide license to develop and commercialize two Phase 2-ready biologic drug candidates 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 in multiple indications, announced today that the Company has initiated a Rolling Submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for voclosporin, a...Read the Full Article
RESEARCH TRIANGLE PARK, N.C. (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced the appointments of Jack Bailey to its Board of Directors and Soma Gupta as its Chief Commercial Officer (CCO). Related Article: G1 Therapeutics & Quantum Leap Healthcare Collaborate in Breast Cancer Research Study “We...Read the Full Article
TORONTO, ON / ACCESSWIRE / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced a collaborative research project with the National Research Council of Canada (NRC) to develop novel immunotherapies for vitiligo as well as other indications. Related Article: Edesa Biotech Reports Financial Results for 2019 Fiscal Year Vitiligo is a...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 new initiatives to support the lupus nephritis (LN) community and raise disease awareness on World Kidney Day, during National Kidney Month...Read the Full Article
SUMMIT, N.J. (GLOBE NEWSWIRE) -- Engage Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing an orally inhaled therapy designed to terminate an active epileptic seizure, today announced that its Phase 2b StATES study of Staccato® alprazolam met its primary endpoint which was the proportion of responders achieving cessation of seizure activity...Read the Full Article
SOUTH SAN FRANCISCO, Calif. (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today reported financial results for the quarter and full-year ended December 31, 2019 and summarized recent business results. Related Article: Satsuma Pharmaceuticals Appoints Rob Janosky as Chief Commercial Officer “In 2019, the Satsuma team made significant...Read the Full Article
KIRKLAND, Wash. /PRNewswire/ -- 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 hiring of Gretchen Gary as Vice President of Global Therapy Development. Ms. Gary brings more than 17 years of structural heart sales, training...Read the Full Article
South San Francisco, CA – Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today announced the appointment of Rob Janosky to the newly created position of Chief Commercial Officer. As Satsuma’s Chief Commercial Officer, Mr. Janosky will be responsible for all commercial activities, as well as leading business development and corporate...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX: AUP) (“Aurinia” or the “Company”) today issued its financial results for the fourth quarter and year ended December 31, 2019. Amounts, unless specified otherwise, are expressed in U.S. dollars “2019 was a truly transformational year for Aurinia, highlighted by the positive results...Read the Full Article
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