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
With Reimbursement in Place and Positive Late-Breaking Data, Company Expects Continued Growth in Germany Kirkland, Wash. – October 18, 2018 – Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced that InEK, the German Institute for the Hospital...Read the Full Article
-Target enrollment has been exceeded and completed ahead of schedule -Company anticipates primary data analysis in Q4 2019 VICTORIA, British Columbia-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH/TSX:AUP), a clinical stage biopharmaceutical company focused on the global immunology market, today announced that it has completed enrollment for the AURORA Phase 3 trial ahead of...Read the Full Article
In Randomized Blinded Study, the Carillon Mitral Contour System Catheter-Based Treatment Meets Endpoint for Reduction in Regurgitant Volume KIRKLAND, Wash.- Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, announced results of the company’s landmark REDUCE FMR clinical trial, which...Read the Full Article
September 19, 2018 06:45 AM Eastern Daylight Time VANCOUVER, British Columbia--(BUSINESS WIRE)--Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced it has named Anthony (Tony) Polverino, Ph.D., Executive Vice President of Early Development and Chief Scientific Officer. In his new role, Dr. Polverino will be instrumental in setting...Read the Full Article
KIRKLAND, Wash.- Cardiac Dimensions, Inc. a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the company has randomized its first patient in the CARILLON Pivotal Trial. The CARILLON Trial is evaluating the Carillon® Mitral Contour System® for the treatment of functional...Read the Full Article
G1 Therapeutics (Nasdaq: GTHX), a clinical-stage oncology company, today announced that it is expediting analyses of myelopreservation data from its randomized Phase 2 trial of trilaciclib in combination with chemotherapy and Tecentriq® (atezolizumab) in first-line small cell lung cancer (SCLC). Myelopreservation results from the trial will be reported in the fourth quarter of 2018....Read the Full Article
(Above) The Cordella™ SystemSOURCE: Endotronix, Inc. Endotronix, Inc., a digital health, medtech company dedicated to advancing the treatment of heart failure, today announced the close of a Series D financing round totaling $45 million. The round was led by LSP, investing from its LSP Health Economics Fund 2, and included Aperture Venture Partners, BioVentures Investors, Lumira...Read the Full Article
G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that Garry Nicholson has been appointed to its board of directors, effective September 12, 2018. “We are pleased to welcome Garry as an independent director to our board. He has a breadth of experience in oncology development and commercialization, including leading the global regulatory and...Read the Full Article
ExactVu™ micro-ultrasound platform - now with FusionVu - enables the highest real-time resolution for targeted prostate imaging and biopsy Exact Imaging, the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced it has received Health Canada approval for its FusionVu™ application for micro-ultrasound/MRI fusion...Read the Full Article
Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today reported the achievement of a development milestone in its collaboration with Eli Lilly and Company. In accordance with Zymeworks’ 2013 licensing and collaboration agreement with Lilly, Zymeworks will receive a milestone payment of US$2.0 million for Lilly’s submission of an...Read the Full Article
Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced one-year follow-up data from the REDUCE LAP-HF I clinical study of its Interatrial Shunt Device (IASD®). The IASD is the world's first transcatheter device for heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection...Read the Full Article
Forbius announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for AVID200, an isoform-selective TGF-β inhibitor. This enables the company to begin a Phase 1 clinical study to evaluate AVID200 as a potential treatment for diffuse cutaneous systemic sclerosis (SSc), a life-threatening fibrotic disease. SSc is a rare, severe, and...Read the Full Article
Forbius (Formation Biologics) announced today that it has been awarded a Product Development grant totaling $18.75 million from the Cancer Prevention and Research Institute of Texas (CPRIT). The grant will support operations and Phase 2a development of AVID100, a highly potent anti-EGFR antibody-drug conjugate, in three cancer indications with significant unmet medical...Read the Full Article
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Acebilustat is the first novel anti-inflammatory molecule evidencing the potential to reduce frequency of pulmonary exacerbations and prolong time to first exacerbation in CF patients Celtaxsys, with continued support from the CF Foundation, has commenced preparations for designing and executing the acebilustat Phase 3 clinical program ATLANTA – Celtaxsys, Inc., a clinical...Read the Full Article
(Reuters) - Privately held Celtaxsys Inc said on Thursday a mid-stage trial testing its experimental cystic fibrosis treatment was successful in reducing a key symptom of the genetic lung disease, but did not improve lung function. There are few treatment options for the 70,000 cystic fibrosis patients worldwide, who rarely live beyond...Read the Full Article
VICTORIA, British Columbia-- Aurinia Pharmaceuticals Inc. today announced that it will release its second quarter 2018 financial results on Thursday, August 9, 2018, after the market closes. Aurinia’s management will host a conference call to discuss the company’s second quarter 2018 financial results and provide a general business update. The conference call...Read the Full Article
Relationship allows UroGPO’s 550+ Member Practices across the USA to access the ExactVu™ Micro-Ultrasound Platform TORONTO, CANADA - Exact Imaging, the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced today that it has become a UroGPO Imaging Partner. UroGPO is the preeminent urology specific...Read the Full Article
SAN CARLOS, Calif., /PRNewswire/ -- BAROnova, Inc., announced today that it has submitted a Pre-Market Approval (PMA) application for the TransPyloric Shuttle device intended for the treatment of obesity to the Food and Drug Administration (FDA). Obesity is a worldwide epidemic with over 40% of adult Americans suffering from obesity and its attendant co-morbidities. ...Read the Full Article
MONTRÉAL and BOSTON, /CNW/ - enGene Inc., a biotechnology company developing novel non-viral vector gene therapies to provide oral delivery of a wide range of protein drugs, including the Gene Pill™ , today announced the appointment of Jason D. Hanson as President, Chief Executive Officer and Director. Mr. Hanson will succeed enGene co-founder Anthony Cheung, Ph.D., who will assume...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH/TSX: AUP), a clinical stage biopharmaceutical company focused on the global immunology market, today announced the initiation of its Phase 2 trial evaluating voclosporin ophthalmic solution (VOS) for the treatment of dry eye syndrome (DES). VOS, which is a proprietary nanomicellar formulation, enables high concentrations...Read the Full Article
SOUTH SAN FRANCISCO, California, /PRNewswire/ -- Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of pre-cancerous lesions caused by human papilloma virus (HPV) infection, has raised $15 million in Series C-1 financing led by Hillhouse Capital Management. Sirona Capital, along with existing investors Canaan Partners, Sofinnova Ventures, Brace Pharma Capital,...Read the Full Article
RESEARCH TRIANGLE PARK, N.C., July 09, 2018 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq:GTHX), a clinical-stage oncology company, today announced appointments for two newly created executive leadership roles to support the company’s continued growth. John Demaree joins the company as Chief Commercial Officer and Stillman Hanson has been named General Counsel. “We...Read the Full Article
Source: Life Science Leader By Wayne Koberstein, Executive Editor, Life Science Leader magazineFollow Me On Twitter @WayneKoberstein The Enterprisers: Life Science Leadership In Action External LinkRead the Full Article
IN 2016, AN ESTIMATED 564,000 CANADIANS SUFFERED FROM DEMENTIA. By 2031, says the Alzheimer’s Society of Canada, that figure will rise to 937,000. In the US it is estimated that the Alzheimer’s burden will triple from 5.3 million people today to 16 million by 2050. Worldwide, nearly 44 million people have or...Read the Full Article
As life expectancies around the globe continue to go up, the accompanying steady rise in senior populations has given way to a newly intensified global focus on dementia in recent years. Dr. Margaret Chan, director-general of the World Health Organization, underscored the urgency of current and future needs in her 2015 address to...Read the Full Article
SOURCE: Endotronix, Inc. LISLE, Ill., June 28, 2018 /PRNewswire/ -- Endotronix, Inc., a digital health, medtech company dedicated to advancing the treatment of heart failure, today announced they have joined the American Heart Association's Center for Health Technology & Innovation's (CHTI) Innovators Network. The collaboration allows Endotronix to integrate the Association's digital resources into the Cordella™...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH/TSX:AUP), a clinical stage biopharmaceutical company focused on the global immunology market, today announced the enrollment of the first patients into the AURORA 2 extension study in lupus nephritis and the initiation of its Phase II trial in focal segmental glomerulosclerosis (FSGS). The first patients have...Read the Full Article
VANCOUVER, British Columbia--(BUSINESS WIRE)--Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, announced today that it has closed its previously announced underwritten public offering (the “Offering”) of 6,210,000 common shares, including the underwriters’ full exercise of their over-allotment option to purchase 810,000 additional...Read the Full Article
RESEARCH TRIANGLE PARK, N.C., June 08, 2018 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq:GTHX), a clinical-stage oncology company, today announced that Cynthia Schwalm and Willie Deese have been appointed to its board of directors, effective June 7, 2018. “We are pleased to welcome Cynthia and Willie as new independent directors to our board. Cynthia’s expertise in commercialization and Willie’s experience in...Read the Full Article
Phase 2b Trial Design and Enrolled Patient Demographics to be Presented at the 41st European Cystic Fibrosis Society Conference ATLANTA – May 17, 2018 – Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare inflammatory diseases, today announced the last patient, last visit in its...Read the Full Article
Vancouver, Canada, Tokyo, Japan and Basking Ridge, NJ (May 14, 2018)– Zymeworks Inc. (NYSE/TSX: ZYME), aclinical-stage biopharmaceutical company developing multifunctional therapeutics, and Daiichi Sankyo Company, Limited (Daiichi Sankyo) announced today that they entered into a new license agreement, building upon their 2016 cross-licensing and collaboration agreement. “With a successful track record and...Read the Full Article
Topline Data Expected H2-2019 Peachtree BioResearch Solutions to Execute Multi-Center Trial SUMMIT, N.J., May 03, 2018 (GLOBE NEWSWIRE) -- Engage Therapeutics, Inc., today announced dosing of the first patient in its multi-center, double-blind, randomized Phase 2b StATES (Seizures) trial to investigate the safety and efficacy of Staccato alprazolam in subjects with epilepsy...Read the Full Article
KIRKLAND, Wash.--(BUSINESS WIRE)-- Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for patients with heart failure, today announced the company has closed a $39 million Series B financing. The round includes new investor, Australia-based Hostplus, venture debt from Oxford Finance LLC, as well as support from existing investors...Read the Full Article
Quebec City, Quebec, April 24, 2018 – Opsens Inc. (“Opsens” or the “Company”) (TSX:OPS)(OTCQX:OPSSF) applauds Japan’s Ministry of Health, Labor and Welfare (“MHLW”) on its new regulation requiring the evaluation of any coronary stenosis prior to its treatment, specifically mentioning Fractional Flow Reserve (“FFR”) as a preferred assessment method. The MHLW recently revised medical fees and established...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 Celgene Corporation has exercised its right to expand its collaboration agreement for the research, development, and commercialization of bispecific antibody therapeutics using Zymeworks’ Azymetric™ platform. “The team at Celgene has made excellent progress developing bispecific...Read the Full Article
LISLE, IL - APRIL 12, 2017- Endotronix, Inc., a medical technology company providing device and digital health solutions for heart failure management, today announced the appointment of seasoned life sciences executive and entrepreneur John Flavin as Chief Financial Officer. He joins the team as the company prepares to scale business operations in...Read the Full Article
Transaction to expand Orthofix’s Spine Fixation portfolio with innovative artificial disc designed to restore natural and physiologic motion to the spine. LEWISVILLE, Texas--(BUSINESS WIRE)--Orthofix International N.V. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products and value-added services, today announced that it has entered into a definitive agreement to acquire...Read the Full Article
RESEARCH TRIANGLE PARK, N.C., March 12, 2018 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq:GTHX), a clinical-stage oncology company, today announced the closing of an underwritten public offering of 3,910,000 shares of its common stock at a public offering price of $29.50, including 510,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional...Read the Full Article
Statistically significant results highlight benefit of trilaciclib in several prospectively-defined parameters, including: Grade 4 neutropenia, G-CSF usage, and chemotherapy dose reductions and delays Clinically meaningful data favoring trilaciclib versus placebo, including: febrile neutropenia, Grade 3/4 anemia, and red blood cell transfusions Management to host webcast and conference call today at 8 a.m. EST...Read the Full Article
VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc., (NASDAQ: AUPH / TSX: AUP) today announced it has received this year’s Company of the Year Award from LifeSciences BC. The 2018 LifeSciences BC award winners will be recognized at this year’s annual dinner presented by FARRIS, held on April 19, 2018 in Vancouver. “As a...Read the Full Article
New patents build on previously granted composition of matter protection for acebilustat, with additional intellectual protection for use in cystic fibrosis, as well as new compositions for second generation anti-inflammatory molecules Acebilustat, the most advanced new candidate in the CF anti-inflammatory pipeline, is a first in-class, oral anti-inflammatory medicine currently being assessed...Read the Full Article
Canada’s Edesa Biotech Inc. is one step closer to making a drug to treat diseases in dermatology and gastroenterology a reality, with funding that includes an investment from Spain, secured with the help of the Canadian Trade Commissioner Service (TCS). Bringing a new drug to market is a long, complex and expensive process. Edesa Biotech Inc., an...Read the Full Article
ATLANTA, GA – Celtaxsys, Inc., a clinical stage drug development company focused on developing novel therapies for rare inflammatory diseases, today announced the successful completion of a Series E financing led by Invus. Additional investors in the financing include Domain Associates, Lumira Capital, Masters Capital Management, RMI Partners and the Georgia Research...Read the Full Article
“Technology can save your life” is a threadbare cliché. But for Rob Sandler, a 50-year-old senior marketing executive at medical imaging firm Exact Imaging, that overused phrase transformed overnight into a sacred truth. During a routine test of a high-resolution ultrasound machine developed by the company, it spotted something wrong: Sandler had...Read the Full Article
KalGene Pharmaceuticals Inc. today announced the closing of a Series A financing to support the advancement of its lead Alzheimer's therapeutic program. The syndicated investment was led by Lumira Capital and included participation from Anges Québec, Anges Québec Capital, Accel-Rx Health Sciences Accelerator and a number of Canadian family offices. In addition...Read the Full Article
ANAHEIM, CA – November 14, 2017 — Corvia Medical, Inc., a privately-held medical device company that developed a first-in-class transcatheter structural heart device to treat heart failure, today announced that it has enrolled the first patients in its global multicenter trial (REDUCE LAP-HF II) of the Interatrial Shunt Device (IASD) for the...Read the Full Article
A free app that’s all carrot, no stick — offering users loyalty points for completing quizzes and surveys about healthy living — has gotten a $1.5 million boost from the Ontario government. The Toronto-based company behind it said “we are a nation so addicted to our phones and also incredibly addicted to...Read the Full Article