ThursdayAug 10, 2023 1:28 pm

BioMedNewsBreaks – Genprex Inc. (NASDAQ: GNPX) Granted FDA Orphan Drug Designation for REQORSA(R) for Patients with SCLC

Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing treatments for patients with cancer and diabetes, today announced that the United States Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) to the company’s lead drug candidate, REQORSA(R) Immunogene Therapy (quratusugene ozeplasmid), for the treatment of small cell lung cancer (“SCLC”). In addition to ODD for the treatment of SCLC, in June 2023, the FDA granted Fast Track Designation (“FTD”) for REQORSA Immunogene Therapy, in combination with Genentech Inc.’s Tecentriq(R) in patients with extensive-stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression…

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WednesdayAug 09, 2023 12:48 pm

BioMedNewsBreaks – HippoFi Inc. (ORHB) Collaborates to Deliver One-of-a-Kind Technology Across US Market

HippoFi (OTC: ORHB), a leading health care technology company and authority in spinal biologics, today announced its execution of an exclusive deal with Italian biomedical manufacturing company, BPB Medica. This comes as HippoFi’s PUR Biologics is preparing to launch PURmarrow360 throughout the U.S., aiming to provide a safe and simple surgical device, specifically designed to selectively capture a patient’s own bone marrow aspirate (“BMA”) and mesenchymal stem cells (“MSCs”). Surgeons can combine these patient-specific live-cells with any allograft, allogenic or synthetic bone substitute during surgery. “We are confident in the executive leadership and experience of HippoFi and PUR Biologics and…

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WednesdayAug 09, 2023 11:53 am

BioMedNewsBreaks – Jupiter Wellness Inc. (NASDAQ: JUPW) Announces Positive Efficacy Results from Clinical Study of NoStingz

Jupiter Wellness (NASDAQ: JUPW), a diversified company that supports health and wellness, today announced data from a recent clinical study of NoStingz, its proprietary topical sunscreen formulated to protect users from jellyfish, sea lice and UVA/UVB rays. According to the update, Portuguese man-o’-war (“MOW”), a marine hydrozoan closely related to jellyfish, has a powerful sting that has been known to kill humans. The present study used MOW gathered from the Atlantic Ocean near Key West, Florida, in 51 trials conducted testing three sunscreen compounds, including NoStingz, against control. Reportedly, the NoStingz area of the participants’ arms had a statistically significant…

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WednesdayAug 09, 2023 11:44 am

BioMedNewsBreaks — Renovaro BioSciences Inc. (NASDAQ: RENB), GEDi Cube Announce LOI to Merge, Focus on Fight Against Cancer

Cutting-edge AI/machine learning technology with validation in humans for early diagnosis of lung cancer Renovaro BioSciences Inc. (NASDAQ: RENB) (formerly NASDAQ: ENOB), an advanced, preclinical biotechnology firm in cell, gene and immunotherapy focused on solid tumors with short life expectancy, and GEDi Cube Intl Ltd. have executed a binding, exclusive letter of intent (“LOI”). The LOI outlines the merge of a subsidiary with GEDi Cube, a cutting-edge health AI company. According to the announcement, the resulting company would focus on accelerating the diagnosis of cancer and other diseases, as well as enhancing treatment effectiveness, discovering new therapies and expanding access to life-saving technologies. According to the announcement, Renovaro Biosciences officials…

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WednesdayAug 09, 2023 11:06 am

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Announces First Peer-Reviewed Publication Based on Its VECG Technology

HeartBeam (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only credit card-size 3D-vector electrocardiogram (“VECG”) platform for patient use at home, allowing for the creation of rich data for AI. The company today announced the publication of a foundational study demonstrating the ability of its VECG platform to detect the presence of coronary artery blockages. The publication* appeared in JACC: Advances, a journal of the American College of Cardiology, and discussed how HeartBeam’s VECG technology detects the presence of a coronary occlusion, the cause of heart attacks, with the same accuracy as a standard 12-lead…

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TuesdayAug 08, 2023 1:01 pm

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Appoints Deborah Castillo to Lead Regulatory Strategy and Execution

HeartBeam (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only credit card-size 3D-vector electrocardiogram (“VECG”) platform for patient use at home, allowing for the creation of rich data for AI. The company today announced its appointment of Deborah Castillo, PhD, as vice president of regulatory affairs. An experienced biomedical engineer with extensive knowledge of FDA, EU and Health Canada regulations, Castillo has significant expertise in cardiovascular diseases, neuroscience and medical devices that support these functions. Prior to joining HeartBeam, Deborah served as director of regulatory affairs neuromodulation at LivaNova, a global medical device company creating…

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MondayAug 07, 2023 1:05 pm

BioMedNewsBreaks – CNS Pharmaceuticals Inc.’s (NASDAQ: CNSP) Berubicin Distinguished with Unique Capabilities

CNS Pharmaceuticals (NASDAQ: CNSP), a Texas-based cancer drug innovator, is focused on advancing its potentially pivotal clinical trial to track the effectiveness of drug candidate Berubicin in treating glioblastoma (“GBM”) brain cancers. Berubicin has already produced one patient with over 15 years of GBM survival. “Berubicin distinguishes itself by being virtually unique in its status as a cancer-fighting anthracycline that crosses the blood-brain barrier to attack central nervous system tumors directly. Berubicin also distinguished itself by presenting statistically significant improvement in nearly half of the two dozen patients evaluated in a phase I trial in 2006, including one patient whose…

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FridayAug 04, 2023 3:33 pm

BioMedNewsBreaks – Genprex Inc.’s (NASDAQ: GNPX) Third Fast Track Designation Validates REQORSA(R)’s Potential

Genprex (NASDAQ: GNPX), a gene therapy company, recently received U.S. FDA Fast Track Designation (“FTD”) for its lead product candidate, REQORSA(R) immunogene therapy, in combination with Tecentriq(R), a cancer immunotherapy treatment developed and sold by Genentech, Inc., in patients with extensive-stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. “The FTD is for the company’s Acclaim-3 patient population, and Genprex expects to initiate its Acclaim-3 clinical trial by enrolling the first patient in the third quarter of 2023… The company previously received two other FTDs. In 2020, Genprex…

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FridayAug 04, 2023 11:10 am

BioMedNewsBreaks – Jupiter Wellness Inc. (NASDAQ: JUPW) Delays SRM Entertainment Inc. Spin-Off, Distribution of Common Stock

Jupiter Wellness (NASDAQ: JUPW), a wellness company focused on hair metabolism and skin therapies, has temporarily postponed the spin-off and common stock distribution of its majority-owned subsidiary, SRM Entertainment Inc. According to the announcement, the distribution of shares of common stock at $0.0001 per share has been delayed; the distribution had been planned for Aug. 3, 2023, with the trading date of SRM common stock on the NASDAQ exchange beginning on Aug. 4, 2023. The announcement did note that the previously announced record date of July 7, 2023, remains the same. “The company remains intent on effectuating the distribution as soon…

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ThursdayAug 03, 2023 12:47 pm

BioMedNewsBreaks – CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Reports on Berubicin Pivotal Study, Announces Participation in Biotech Conference

CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, released an update on its ongoing clinical study evaluating Berubicin for the treatment of recurrent GBM, an aggressive and incurable form of brain cancer. According to the report, the company continues to see rapid progression and acceleration of enrollment for the study, with 180 patients of the 243 expected currently enrolled across 46 clinical trial sites. In addition, CNS has documented the necessary number of patients reaching the primary efficacy endpoint, or overall survival, to conduct…

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