Month: June 2021

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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GeneTx and Ultragenyx Receive Clearance from Health Canada to Begin Clinical Study of GTX-102 in Canada for the Treatment of Angelman Syndrome

06/01/2021

Excerpt from the Press Release: SARASOTA, Fla. and NOVATO, Calif., May 19, 2021 (GLOBE NEWSWIRE) — GeneTx Biotherapeutics LLC and Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), companies partnered in the development of intrathecally administered GTX-102, an investigational treatment for Angelman syndrome, today announced that they have received clearance from Health Canada to begin enrolling the Phase…

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The Lancet Publishes Results of Axumin® (Fluciclovine F 18) PET Imaging Study Demonstrating Improved Patient Outcomes in Patients with Recurrent Prostate Cancer

06/01/2021

Excerpt from the Press Release: BURLINGTON, Mass. & OXFORD, England–(BUSINESS WIRE)–Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, is pleased to share news of the publication of a study from researchers at Winship Cancer Institute of Emory University (Winship) evaluating Axumin® (fluciclovine F 18) PET…

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