Industry News

Using Medical Images in YourClinical Trial? Keep ThemWorking for You Long after Your Trial Concludes

07/24/2023

Medical images play a pivotal role in many clinical trials today. Medical images are assets of tremendous value, yet much of that value remains untapped post trial. Why? Because Sponsors and CROs have not had the software and infrastructure necessary to aggregate and store images, or make them available. With the Fujifilm TeraMedica VNA –…

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CENTOGENE Biodatabank Reveals Unique Genetic Variants in World’s Largest Niemann-Pick Type C1 Disease Cohort

07/21/2023

Results Published in European Journal of Human Genetics Demonstrate Unprecedented Insights to Accelerate Potential Treatment Options Excerpt from the Press Release: CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, July 12, 2023 (GLOBE NEWSWIRE) — CENTOGENE N.V. (Nasdaq: CNTG) (the “Company”), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced…

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Elixir Medical Completes Enrollment of INFINITY-SWEDEHEART Clinical Trial

07/20/2023

-Largest randomized trial of DynamX Bioadaptor to date with 2,400 patients enrolled, covering real-world population- Excerpt from the Press Release: MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of breakthrough cardiovascular technologies, today announced enrollment completion in INFINITY-SWEDEHEART, a prospective, multicenter, single-blind, randomized clinical trial of the DynamX® Coronary Bioadaptor System, the first metallic coronary artery implant…

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Ayala Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA Regarding AL102 for the Treatment of Desmoid Tumors

07/19/2023

Company confirms FDA agreement on key elements of the Phase 3 segment of ongoing RINGSIDE study, including dosing regimen of 1.2mg once daily Enrollment in Phase 3 continuing as planned Excerpt from the Press Release: REHOVOT, Israel & MONMOUTH JUNCTION, N.J., July 05, 2023 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology…

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ESMO GI Data: Agenus’ Botensilimab/Balstilimab Combination Achieves Unprecedented Survival in Advanced Colorectal Cancer

07/18/2023

Median Overall Survival of 20.9 Months for Patients Without Active Liver Metastases Surpasses the Recently Reported 12.9-Month Benchmark with Standard of Care in this Population Excerpt from the Press Release: LEXINGTON, Mass.–(BUSINESS WIRE)–Immuno-oncology leader, Agenus (Nasdaq: AGEN), shared promising data today from its Phase 1b trial on the botensilimab and balstilimab combination at a late-breaking…

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C4 Therapeutics Announces FDA Clearance of Investigational New Drug Application for CFT8919, an Orally Bioavailable BiDAC™ Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer

07/17/2023

Excerpt from the Press Release: WATERTOWN, Mass., July 05, 2023 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science to develop a new generation of small-molecule medicines and transform how disease is treated, today announced that the U.S. Food and Drug Administration (FDA)…

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Oxford BioTherapeutics brings Phase Ib trial with OBT-076 to Europe

07/14/2023

Oxford BioTherapeutics expanded its US-based trial investigating OBT-076 as monotherapy and combination treatment to European sites. Excerpt from the Press Release: UK-based oncology company Oxford BioTherapeutics has initiated a Phase Ib trial evaluating OBT-076 in patients with solid tumours at a European site. The company dosed the first patient with its CD205 targeting antibody-drug conjugate…

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Alzheimer’s drug Leqembi gets full FDA approval. Medicare coverage will likely follow

07/13/2023

Excerpt from the Press Release: The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer’s disease. The action means that Leqembi, whose generic name is lecanemab, should be widely covered by the federal Medicare health insurance program, which primarily serves adults age 65 and older. So more people who…

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Blue Lake Biotechnology Doses First Child in Clinical Trial of Novel Intranasal Vaccine Against Respiratory Syncytial Virus

07/12/2023

Excerpt from the Press Release: ATHENS, Ga. and LOS GATOS, Calif., June 29, 2023 /PRNewswire/ — Blue Lake Biotechnology, Inc., a clinical stage intranasal vaccine company harnessing the full breadth of the immune system to protect against serious infectious disease, announced that the first child has been dosed in its Phase 1/2a trial (NCT05655182) of…

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Zenocutuzumab (Zeno) granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration for the treatment of NRG1+ pancreatic cancer

07/11/2023

Excerpt from the Press Release: UTRECHT, The Netherlands and CAMBRIDGE, Mass., June 29, 2023 (GLOBE NEWSWIRE) — Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment…

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