CoapTech Awarded Seed Fund Grant from Pennsylvania Pediatric Device Consortium

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CoapTech, Inc, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today it has been awarded a $50,000 grant by the Children’s Hospital of Philadelphia-based Pennsylvania Pediatric Medical Device Consortium (“PPDC”) for its PUMA-G Peds System, a device designed to provide a safer way to place feeding tubes in children.

Maxim Biomedical Inc. Receives EUA for New ClearDetect™ COVID-19 Antigen Home Test

Image of COVID-19 antigen test box
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Maxim Biomedical (MaximBio) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for their new ClearDetect™ COVID-19 Antigen Home Test (ClearDetect™). The at-home diagnostics market is growing rapidly and is expected to value over USD 7.6 billion and register a CAGR of over 5.4% by the end of 2028.  MaximBio designed, tested, and will manufacture their new assay in the United States to help meet this growing demand for home testing.

TOUCH, The Black Breast Cancer Alliance, and Breastcancer.org unite for a groundbreaking new movement to advance the science for Black Breast Cancer

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TOUCHBBCA and Breastcancer.org announced the upcoming launch of When We Tri(al), a movement dedicated to empowering and educating Black women on the importance of clinical trial participation. The movement aims to change the devastating breast cancer mortality rates for Black women, who are 41% more likely to die from breast cancer than white women.

SwanBio Therapeutics Announces FDA Investigational New Drug Clearance for First AAV-Based Gene Therapy for the Treatment of Adrenomyeloneuropathy

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SwanBio Therapeutics, a gene therapy company advancing AAV-based therapies for the treatment of devastating, genetically defined neurological conditions, today announced that its Investigational New Drug (IND) application for its lead candidate, SBT101, for the treatment of adrenomyeloneuropathy (AMN), was cleared by the U.S. Food and Drug Administration (FDA).

Cartesian Therapeutics Doses Patient with First Allogeneic RNA Cell Therapy for Multiple Myeloma

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Cartesian Therapeutics, a fully integrated clinical-stage biotechnology company pioneering RNA cell therapy in and beyond oncology, today announced that it has dosed the first patient in a Phase 1/2a multicenter clinical study evaluating Descartes-25 in patients with multiple myeloma.  To the company’s knowledge, Descartes-25 is the first off-the-shelf RNA cell therapy to enter clinical trials for any cancer and marks the company’s fifth FDA Investigational New Drug (IND) allowance in five years.  Descartes-25 is produced at Cartesian’s wholly owned cGMP manufacturing facility with the company’s proprietary RNA Armory® cell manufacturing platform.  This platform now includes an internally developed, Part 1271-compliant Master Cell Bank of human umbilical cord Mesenchymal Stem Cells (MSC) that was used to engineer Descartes-25.

Applied Pharmaceutical Science Inc. Announces FDA Approval of Investigational New Drug Application for APS03118, a Next generation RET Original New Drug for Unlimited Cancers

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Applied Pharmaceutical Science, Inc. (“APS” or “the Company”), has recently announced the Investigational New Drug (IND) application for its self-developed breakthrough new drug APS03118, a next generation selective RET inhibitor, has been approved by the U.S. Food and Drug Administration (FDA). The clinical application is also in the process of being submitted to the National Medical Products Administration (NMPA) in China, and a global multi-center clinical trial is in the pipeline for initiation in the second quarter of 2022 in the U.S., China and Australia etc.

Arbutus Announces 2022 Corporate Objectives and Provides Financial Update

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Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced its 2022 corporate objectives and provided a financial update.

CASI Pharmaceuticals Partner, BioInvent, Announces BI -1206 Granted Orphan Drug Designation By The U.S. FDA For The Treatment Of Patients With Follicular Lymphoma

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CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announced today, that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its partner BioInvent International AB, for BI-1206, an investigational anti-FcyRllB antibody, for the treatment of follicular lymphoma (FL), the most common form of slow-growing Non-Hodgkin lymphoma (NHL).

LyGenesis Announces a New Peer-Reviewed Publication Expanding its Liver Regeneration Technology

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LyGenesis, a clinical-stage biotechnology company developing cell therapies for patients with end stage liver disease, Type 1 diabetes, end stage renal disease, single enzyme deficiencies, and aging, announced today the publication of a new peer-reviewed paper published in journal Hepatology on its organ regeneration technology.

PhenoVista Biosciences Raises Growth Capital From BroadOak Capital Partners

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PhenoVista Biosciences announced today that it has secured funding from BroadOak Capital Partners, a life science-focused investor. Since its founding in 2014, PhenoVista has democratized access to high-content analysis of physiologically relevant cell models. The investment will be used to develop new complex products, such as models of the blood-brain barrier and platforms for better understanding neurodegenerative diseases.