The FDA Just Approved the First Generic Nasal Spray to Reverse Opioid Overdoses

Time | April 19, 2019

The Food and Drug Administration (FDA) on Friday announced that it granted final approval to the first generic naloxone hydrochloride nasal spray, which can be used to reverse opioid overdoses. The approval is part of the FDA’s wider effort to make tools for stopping or preventing opioid overdoses more accessible and widely used. The agency is also working with drug companies to bring over-the-counter versions of naloxone to market, and is prioritizing the approval of other generic naloxone products. Friday’s announcement, which makes official a tentative approval previously granted to Teva Pharmaceuticals, means there will soon be a generic alternative to Narcan, the widely used naloxone nasal spray sold by Emergent BioSolutions.

Spotlight

Exosomes are tiny cell-derived vesicles which have captured the attention of cell biologists, and diagnostic and therapeutic industries. At first, it was thought that exosomes contained debris with no biological significance. However, recent studies have revealed that there is more to them than first thought.

Spotlight

Exosomes are tiny cell-derived vesicles which have captured the attention of cell biologists, and diagnostic and therapeutic industries. At first, it was thought that exosomes contained debris with no biological significance. However, recent studies have revealed that there is more to them than first thought.

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CSA Medical Inc | October 22, 2020

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BUSINESS INSIGHTS

Sinorda Biomedicine and Porton Advanced to Fast-track the Development of Cell Therapies for Solid Tumors

Porton Advanced | April 25, 2022

Suzhou Porton Advanced Solutions Ltd. and Guizhou Sinorda Biomedicine Co. Ltd. announced a long-term strategic relationship in cell and gene therapy research and development and platform development. Porton Advanced provides plasmids, cell therapy, gene therapy, oncolytic virus, mRNA treatment, and bacterial therapy as part of an end-to-end gene and cell therapy CDMO service platform. Sinorda Biomedicine focuses on the R&D of revolutionary drugs for digestive tract disorders, tumor immunotherapy, and oncolytic virus therapy and has multiple new drug projects in the clinical stage, thanks to its extensive expertise in domestic and international new drug filing. Jiangsu Tairui Sinorda Biomedicine Pharmaceutical Technology Co. Ltd., a subsidiary, conducts pre-clinical and clinical research on tumor immune pharmacology and efficacy. Under the terms of the agreement, Porton Advanced will help Sinorda Biomedicine speed up the development, production, and registration of breakthrough cell therapies, such as its T-cell immunotherapy product for colorectal cancer, SND002 and other pipelines. Sinorda Biomedicine will partner with Porton Advanced to support its cell and gene therapy R&D and production. The first collaborative initiative, SND002, has been approved for Phase II clinical trials in Europe. The product had previously been recognized by the Chinese National Science and Technology Major Project for "the Breakthrough New Drugs." The beginning of this key initial initiative allows Porton Advanced and Sinorda to combine resources and expertise, promising increased synergy in the clinical development and approval of Sinorda's SLN-T program. "Sinorda Biomedicine has a proven track record in drug development in China, US and Europe. The company possesses great expertise in immunology and oncolytic viruses, as well as cutting-edge immune functional assays, technologies, and capabilities. I am excited to see how our end-to-end cell and gene therapy CDMO platforms and quality systems can complement these capabilities and enhance Sinorda's pipeline. Supporting Sinorda's development, production and regulatory filing and accelerating its cell therapy drugs to market is a great cause and a great opportunity. We look forward to the opportunity to help Sinorda establish advanced therapies that benefit patients globally." Dr. Yangzhou Wang, CEO of Proton Advanced

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IMI Releases Tamper Evident Caps with DoseID Certified RFID

International Medical Industries, Inc. | February 28, 2022

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