News & Updates

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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Phase 3 OCEAN study demonstrates that melphalan flufenamide is at least as efficacious as pomalidomide, the most used medicine in relapsed refractory multiple myeloma

05/31/2021

Excerpt from the Press Release: Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces positive topline results from the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melphalan flufenamide versus pomalidomide in patients with relapsed refractory multiple myeloma (RRMM).…

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AXIM® Biotechnologies Completes Pre-Clinical Drug Studies on SPX-1009 Compound Proving Suppression of Melanoma Cells

05/30/2021

Excerpt from the Press Release: SAN DIEGO, May 26, 2021 (GLOBE NEWSWIRE) — AXIM®Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM® Biotech,” “AXIM” or “the Company”), an international healthcare solutions company targeting oncological and COVID-19 research, announced today that it has completed pre-clinical drug studies on its patent pending compound SPX-1009, demonstrating the suppression of malignant metastatic melanoma cells. The…

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FDA gives emergency use approval for Covid-19 antibody drug developed by Vir Biotechnology, GlaxoSmithKline

05/29/2021

Excerpt from the Article: The U.S. Food and Drug Administration gave an emergency use authorization to the antibody treatment developed by Vir Biotechnology and GlaxoSmithKline for treating mild-to-moderate Covid-19 in people aged 12 years and older. The antibody drug, Sotrovimab, is not authorized for patients who are hospitalized due to Covid-19 or require oxygen therapy, the health regulator said…

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Centivax Drives Next-Generation COVID-19 Antibody into the Clinic

05/28/2021

Excerpt from the Press Release: When COVID-19 shut down the world’s economies, governments across the globe, including the United States, began to pour money into vaccine research and development. Those funds led to the rapid development and deployment of vaccines, but few therapeutics against the virus have achieved the same speed of development. And that may…

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Recorded Webinar: Accelerating Trials Through Innovative Clinical Trial Designs

05/27/2021

On May 25th, 2021 TrialStat’s very own Christopher Kata, and Heather Williams hosted an incredible webinar with our guest Speaker John Amrhein, VP of McDougall Scientific. John presented his perspective on “Accelerating Trials Through Innovative Clinical Trial Designs” and taking questions from our live audience! Download the Slide Deck, and Watch The Webinar Recording On…

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