Announcements

Theradaptive Wins Additional FDA Breakthrough Designation for Spinal Fusion

02/22/2022

Excerpt from the Press Release: FREDERICK, Md. and BOSTON, Feb. 15, 2022 /PRNewswire/ — Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Medical Device designation for its OsteoAdapt SP Spinal Fusion implant indicated for posterolateral spinal fusion to treat degenerative disc disease, spondylolisthesis,…

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Enanta Pharmaceuticals Doses First Subject in a Phase 1 Clinical Study of EDP-235, its Oral 3CL Protease Inhibitor Specifically Designed for the Treatment and Prevention of COVID-19

02/22/2022

Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it has dosed the first subject in its Phase 1 clinical trial of EDP-235, a coronavirus 3CL protease inhibitor (also known as the main coronavirus…

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EyePoint Pharmaceuticals Announces Updated Positive Interim Safety and Efficacy Data from Ongoing Phase 1 DAVIO Clinical Trial Evaluating EYP-1901 for the Treatment of Wet AMD

02/21/2022

– Continued positive efficacy and durability with stable visual acuity (VA) and optical coherence tomography (OCT) through eight-month follow-up – 41% of eyes remained rescue free up to nine months after a single dose of EYP-1901 – Positive safety data continued with no dose limiting toxicities, no ocular serious adverse events (SAEs) and no drug-related…

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Maze Therapeutics Presents New Preclinical Data Supporting Advancement of MZE001 as a Potential Treatment for Pompe Disease

02/21/2022

Findings Highlight Potential of Oral Substrate Reduction Therapy to Lower Disease-Causing Glycogen Build-up as a Treatment for Pompe Disease Data Support Advancement of MZE001 into Phase 1 Clinical Trial Expected to Start in First Half of 2022 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Maze Therapeutics, a company translating genetic insights into new…

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Veklury® (Remdesivir) Retains Antiviral Activity Against Omicron, Delta and Other Emergent SARS-CoV-2 Variants in Multiple In Vitro Studies

02/21/2022

— Data Supports the Continued Use of Veklury for Treatment of COVID-19 for Current SARS-CoV-2 Variants – Excerpt from the Press Release: FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today released data demonstrating the in vitro activity of Veklury® (remdesivir) against ten SARS-CoV-2 variants, including Omicron. Results of Gilead studies are consistent with other in vitro studies independently conducted…

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Regen BioPharma, Inc. to Initiate Development of its Modified mRNA anti-Cancer Vaccine Technology

02/18/2022

Excerpt from the Press Release: SAN DIEGO, Feb. 11, 2022 /PRNewswire/ — Regen BioPharma, Inc. (PINK: RGBP) and (PINK: RGBPP) is embarking on a development program to commercialize its modified mRNA anti-cancer vaccine targeting the Survivin protein.  In the first phase of the development program, Regen will design and have experiments carried out that will form the initial…

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Virpax Reports Favorable Preclinical Safety Data for Envelta™ for the Treatment of Acute and Chronic Pain

02/18/2022

– Preclinical study data indicate that intranasal administration of enkephalin (Envelta) is well-tolerated and safe – Excerpt from the Press Release: BERWYN, Pa.–(BUSINESS WIRE)–Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive product candidates for pain management, as well as PTSD, CNS disorders and anti-viral indications, reported promising results from preclinical dose…

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NRx Reports Remarks by Israel Institute for Biological Research on the future of the BriLife™ Covid-19 Investigational Vaccine

02/18/2022

Remarks by Dr. Shmuel Yitzhaki, as published in Globes, an Israeli business newspaper BriLife vaccine may have better neurtralizing ability against Omicron variant than first generation mRNA vaccines, according to IIBR findings Excerpt from the Press Release: RADNOR, Pa., Feb. 11, 2022 (GLOBE NEWSWIRE) — NRx Pharmaceuticals (Nasdaq: NRXP), a clinical-stage, biopharmaceutical company, today reported remarks by Dr. Shmuel…

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Accuray TomoTherapy® Helical Radiotherapy System Helps Preserve Breast Cancer Patients’ Long-term Heart and Lung Functionality

02/17/2022

– Phase III, randomized controlled trial results highlight patient reported outcomes at 10 years’follow-up– TomoTherapy delivered hypofractionated radiotherapy was superior to conventional radiotherapy in maintaining patients’ heart and lung functioning, enabling them to more easily perform daily and leisure time activities, and/or work Excerpt from the Press Release: SUNNYVALE, Calif., Feb. 10, 2022 /PRNewswire/ — Accuray Incorporated (NASDAQ: ARAY)…

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Denali Therapeutics Announces Continued Progress in DNL310 (ETV:IDS) Program for MPS II (Hunter Syndrome) Supporting Planned Initiation of Phase 2/3 Clinical Trial

02/17/2022

Longer-term data in 20 patients show sustained normalization to healthy levels of CSF heparan sulfate and improvements in markers of lysosomal function consistent with durable CNS activity, now with up to one year of intravenous dosing with DNL310 Safety profile with up to 56 weeks of dosing remains consistent with standard-of-care enzyme replacement therapy Data…

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