Industry News

Lyndra Therapeutics Announces Positive Outcome of End-of-Phase 2 Meeting with the FDA for Lyndra’s Weekly Risperidone (LYN-005) for the Treatment of Adults with Schizophrenia and Other Indications

07/29/2021

Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Lyndra Therapeutics, a clinical-stage biotechnology company working to make daily pills a thing of the past, today announced the positive outcome of an end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) providing a clear path to approval for Lyndra’s Weekly Risperidone (LYN-005), the company’s…

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Elucida Oncology Submits IND Application for ELU-001 for the Treatment of Cancers Overexpressing Folate-Receptor Alpha

07/28/2021

Excerpt from the Press Release: MONMOUTH JUNCTION, N.J., July 19, 2021 (GLOBE NEWSWIRE) — Elucida Oncology, a biotechnology company pioneering the next frontier in targeted cancer therapy, announced today that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial of ELU-001,…

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Celsion Reports Data Safety Monitoring Board Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer

07/28/2021

Excerpt from the Press Release: LAWRENCEVILLE, N.J., July 19, 2021 (GLOBE NEWSWIRE) — Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced that following a pre-planned interim safety review of 55 as treated patients randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the Data…

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Selva to Present Preclinical Data at ASV 2021 Demonstrating Prophylactic and Therapeutic Oral Dosing of SLV213 for COVID-19 Protected Lungs from SARS-CoV-2-Induced Damage

07/28/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Selva Therapeutics, Inc. (“Selva”) announced new preclinical data demonstrating SLV213, when given as a prophylactic or a treatment for SARS-CoV-2 infection, protects against SARS-CoV-2-induced diffuse alveolar damage (DAD), which is associated with the early stages of acute respiratory distress syndrome (ARDS). Additional in vitro data show that SLV213 greatly enhances the…

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Tenaya Therapeutics Unveils Preclinical Research Supporting Product Candidate for Rare and Prevalent Heart Disease Indications at ESC Heart Failure 2021

07/27/2021

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tenaya Therapeutics, a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, has unveiled preclinical data supporting drug discovery efforts involving its Precision Medicine Platform at the European Society of Cardiology Heart Failure 2021 (ESC-HF) meeting. The…

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Summit Therapeutics Presents Breakthrough Research Data from Phase II Studies, including Evidence Validating Microbiome Preservation, for its Investigational Drug Ridinilazole

07/27/2021

Excerpt from the Press Release: Cambridge, MA, July 12, 2021 (GLOBE NEWSWIRE) — Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit” or the “Company”) is today displaying three preeminent ePosters at the prestigious 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). Two ePosters bring increased awareness and understanding of the significance of data generated using…

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Elucid Presents Data Demonstrating Its AI Software Can Uniquely Quantify Key Drivers of Heart Attack and Stroke from Computed Tomography

07/27/2021

Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Elucid, a medical technology company developing AI software for physicians to optimize the treatment of patients with known or suspected vascular disease, announced today that its founder Andrew Buckler will present findings from two separate studies at the virtual Society of Cardiovascular Computed Tomography (SCCT) 16th Annual Scientific Meeting.…

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Akoya Announces Publication of the MITRE Study, the First Multi-Institutional Analytical Demonstration of a Spatial Biology Workflow, in the Journal for ImmunoTherapy of Cancer

07/26/2021

Excerpt from the Press Release: MARLBOROUGH, Mass., July 19, 2021 (GLOBE NEWSWIRE) — Akoya Biosciences, Inc., (Nasdaq: AKYA) The Spatial Biology Company®, today announced that the Phenoptics™ mIF solution was used in a multi-site study to demonstrate and validate an automated end-to-end workflow that characterizes PD-1/PD-L1 immune checkpoint signaling in tumor tissue samples. The paper…

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Ocugen, Inc. Announces Initiation of Rolling Submission to Health Canada for COVAXIN™

07/26/2021

Excerpt from the Press Release: MALVERN, Pa., July 15, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that it had initiated a rolling submission to Health Canada for COVAXIN™, the company’s candidate…

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Qualigen Therapeutics, Inc. Announces Submission of Investigational New Drug (IND) Application for QN-165, for the Treatment of COVID-19

07/26/2021

Excerpt from the Press Release: CARLSBAD, Calif., July 14, 2021 (GLOBE NEWSWIRE) — Qualigen Therapeutics, Inc. (NASDAQ: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announced today the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Qualigen’s…

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