Industry News

An expert’s guide to developing medical devices

06/07/2021

Excerpt from the Article: When it comes to designing and building novel medical devices to meet the needs of patients and healthcare systems, developers should rely on the core skills of engineering and design to inform their process. But there are “lessons learned” that are unique to the medical device development process. The team at Goddard has…

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Naveris’ New Saliva Test Detects Head and Neck Cancer

06/07/2021

Excerpt from the Press Release: WALTHAM, Mass.–(BUSINESS WIRE)–A new clinically-validated saliva test has been shown to detect HPV-associated head and neck cancer with high accuracy, a first-of-its-kind study result. Researchers at Washington University School of Medicine in St. Louis used the Naveris, Inc. test to analyze saliva for sequences of the human papilloma virus (HPV)…

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enGene Announces First-in-Human Dosing of EG-70 for the Treatment of Non-Muscle Invasive Bladder Cancer in Phase 1/2 Clinical Trial

06/07/2021

Excerpt from the Press Release: BOSTON and MONTRÉAL, May 27, 2021 /PRNewswire/ – enGene Inc., a clinical-stage biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, today announced the dosing of the first patient in the LEGEND study, a first-in-human Phase 1/2 clinical trial of EG-70 in patients with BCG-unresponsive non-muscle…

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Ontario Cancer Research Community: OICR Cancer Therapeutics Innovation Pipeline – Request for Applications

06/04/2021

Excerpt from the Announcement: The Cancer Therapeutics Innovation Pipeline (CTIP) Program was established to capitalize on Ontario’s expertise in cancer biology and drug discovery to create a pipeline of validated cancer targets and first-in-class or best-in-class, novel, selective lead molecules (small molecules or biologics) that would attract partnerships and/or investment for further preclinical and clinical…

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Senti Bio to Present Data from CAR-NK Cell Oncology Pipeline at ISCT Annual Meeting

06/04/2021

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., May 25, 2021 (GLOBE NEWSWIRE) — Senti Bio, a leading gene circuit company, today announced presentations on its gene circuit engineered allogeneic CAR-NK cell therapy pipeline at the International Society for Cell and Gene Therapy (ISCT) Virtual Annual Meeting. The presentations provide details of Senti Bio’s…

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Health Canada Approves Quidel’s Sofia® SARS Antigen FIA Test for Screening of Asymptomatic Populations With Serial Testing

06/04/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that its Sofia® SARS Antigen FIA is the first rapid antigen test to receive authorization from Health Canada for serial testing for the detection of active…

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AVEO Oncology Announces Positive Results from Randomized Phase 2 Study of Ficlatuzumab in Combination with Cetuximab in Pan-Refractory, Metastatic HNSCC

06/03/2021

Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–AVEO Oncology (Nasdaq: AVEO), a commercial and clinical development stage biopharmaceutical company, today announced results from a randomized confirmatory Phase 2 study of ficlatuzumab as a single agent or in combination with cetuximab (ERBITUX®), an EGFR-targeted antibody, in patients who relapsed or were refractory to prior immunotherapy, chemotherapy, and…

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Ocugen Closes in on Seeking EUA for India-Developed COVID-19 Vaccine

06/03/2021

Excerpt from the Article: Pennsylvania-based Ocugen has moved one step closer to bringing a COVID-19 vaccine developed by India-based Bharat Biotech into the United States market. The company submitted a “Master File” to the U.S., Food and Drug Administration, a necessary step ahead of seeking Emergency Use Authorization. Ocugen and Bharat Biotech have been working together since December to develop COVAXIN,…

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Advaxis Presents Updated Clinical Data from Ongoing Phase 1/2 Trial of ADXS-503 in NSCLC at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting

06/02/2021

Excerpt from the Press Release: PRINCETON, N.J., May 19, 2021 (GLOBE NEWSWIRE) — Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced updated data from the Company’s ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA® which will be presented as a poster at the American…

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NFlection Therapeutics’ NFX-179 Gel Demonstrates Safety and Significant Reduction in p-ERK, a Key Biomarker Driving Neurofibroma Tumor Growth, in Positive Data From a 28-Day Phase 2a Clinical Trial

06/02/2021

Excerpt from the Press Release: WAYNE, Pa., May 26, 2021 /PRNewswire/ — NFlection Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of targeted therapies for rare disorders driven by aberrant activation of the RAS pathway (RASopathies), today announced positive results from a 28-day, Phase 2a, multicenter, randomized, double-blind, parallel-group, vehicle-controlled clinical trial investigating the safety, tolerability,…

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