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Zalgen Labs

Frederick’s Zalgen Immunotherapeutic Confers Complete Protection Against Advanced Multilineage Lassa Infections in Nonhuman Primates

By News, News Archive

Zalgen LabsFREDERICK, Md.Aug. 18, 2023 /PRNewswire/ — Zalgen Labs LLC (Zalgen), a biotechnology and diagnostics company focused on high-impact, neglected infectious diseases, including Lassa Fever (LF), today announced publication of data demonstrating that Arevirumab-3®, its lead immunotherapeutic candidate, is an effective therapeutic for the treatment of Lassa virus infections, with activity against all major viral lineages that cause severe disease in humans, and at very low dosages. 

The study emanated from an extensive and ongoing research collaboration of Zalgen, Tulane University (Tulane), UTMB, and other members of the Viral Hemorrhagic Fever Consortium (VHFC) [www.vhfc.org] and the Viral Hemorrhagic Fever Immunotherapeutic Consortium (VIC) [www.vhfimmunotherapy.org] working on advanced alternatives to treat Lassa fever and other hemorrhagic viral infections.

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Japanvisit

International Delegation from Japan Visits BioHealth Innovation, Inc. in a Bid to Strengthen Biotech Ties

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JapanvisitOn August 16th, BioHealth Innovation, Inc. (BHI) in Rockville, Maryland, hosted a distinguished group of professionals from Japan, representing the International Visitor Leadership Program (IVLP) in collaboration with the U.S. Department of State. This visit marked a significant step towards fostering international relations in the biotechnology sector.

The delegation from Japan arrived with specific objectives for their visit. They aimed to deepen their understanding of technology transfer and the best practices in commercialization. Additionally, they sought to forge strong ties with U.S. technology transfer experts, laying the groundwork for future collaborations. A significant focus was on amplifying biotechnology research and fostering commercial partnerships between the U.S. and Japan. They also aspired to strengthen Japan’s bioeconomy sector, envisioning it as a global epicenter for biotech products and ensuring its biotechnology ecosystems resonate with democratic principles. Furthermore, the delegation intended to heighten the interest of U.S. investors in early-stage biotechnology towards Japanese startups and to broaden the horizons for Japanese companies in the global venture capital arena.

The esteemed group from Japan comprised:

  • Dr. Rei Uematsu, Deputy Director, R&D Division, Industrial Science, Technology and Environment Policy Bureau, Ministry of Economy, Trade, and Industry (METI)
  • Dr. Jun Sato, Attending Physician, Department of Experimental Therapeutics, National Cancer Center Hospital of Japan
  • Dr. Eriko Ogawa, Manager, R&D Division, Amino Up Co., Ltd.
  • Dr. Noriyuki Nishimura, Principal Scientist, National Agriculture and Food Research Organization (NARO)
  • Dr. Masahiro Taniguchi, R&D General Manager, KAICO Ltd.
  • Dr. Minako Sumiyoshi, Regulatory Affairs Officer, Sanatech Seed Co., Ltd.

Representing BioHealth Innovation were Rich Bendis, President and CEO; Luis Gutierrez, Executive in Residence; Albine Martin, Entrepreneur in Residence; and Ethel Rubin, Entrepreneur in Residence.

The visit provided an opportunity for the delegation to learn more about BHI’s mission and services, fostering a deeper understanding and potential for future collaborations.

Rich Bendis, President and CEO of BHI, remarked, “It’s always an honor to host international delegations, especially one as esteemed as this group from Japan. Collaborative efforts like these pave the way for global advancements in biotechnology. We look forward to a future filled with shared knowledge and mutual growth.”

This visit underscores the importance of international collaboration in the biotechnology sector. As the world becomes more interconnected, partnerships like these will be crucial in driving innovation and ensuring the global community benefits from advancements in biotechnology.

MyMD250

FDA Accepts Baltimore’s MyMD Pharmaceuticals’ Investigational New Drug Application (IND) for Phase 2 Study of oral TNF-α inhibitor MYMD-1® in Rheumatoid Arthritis (RA)

By News, News Archive

MyMD250BALTIMORE–()–MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug Application (IND) to evaluate the safety, efficacy, pharmacodynamics and pharmacokinetics of oral TNF-α inhibitor MYMD-1® in patients with active rheumatoid arthritis (RA). The application was based on preclinical data showing that MYMD-1 significantly reduced swelling and other clinical arthritis measures compared to widely used RA therapy, Enbrel® (etanercept).The Company plans to initiate discussions with CRO vendor IQVIA on timing of a Phase 2 study in this indication.

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10XAdd

Addimmune, a Clinical Stage Hiv-Focused Gene Therapy Company, to go Public Through Business Combination With 10x Capital Venture Acquisition Corp. III

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10XAddNEW YORK CITY, NEW YORK and ROCKVILLE, MARYLAND, Aug. 09, 2023 (GLOBE NEWSWIRE) — NEW YORK CITY, NEW YORK and ROCKVILLE, MARYLAND, Aug. 9, 2023 (GLOBE NEWSWIRE) – American Gene Technologies International Inc. (“AGT”) and 10X Capital Venture Acquisition Corp. III (“10X III”) (NYSE: VCXB), a special purpose acquisition company, today announced that they have entered into a merger agreement for a business combination that would result in the combined company being a publicly listed company (the public company following the business combination to be renamed “Addimmune”). The combined company is expected to trade under the ticker symbol “HIV”. Addimmune is a clinical-stage gene and cell therapy company developing a functional cure for HIV. Prior to the combination, the non-HIV assets will spin-off into an entity that will retain the American Gene Technologies name.

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Georgiamune

Gaithersburg’s Georgiamune Inc. Achieves US FDA Clearance for Investigational New Drug (IND) Application and Secures $75 Million in Series A Financing

By News, News Archive

GeorgiamuneGAITHERSBURG, Md.Aug. 9, 2023 /PRNewswire/ — Today, Georgiamune Inc., a privately held, clinical stage biotechnology company, announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for GIM-122, a dual-functioning monoclonal antibody. Furthermore, the company successfully completed a $75M Series A financing, positioning Georgiamune as a promising new biotechnology company in the fields of oncology and autoimmune diseases.

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Precigen

Precigen Announces FDA Confirmation that the Ongoing Phase 1/2 Study of PRGN-2012 AdenoVerse Immunotherapy Will Serve as the Pivotal Study to Support Accelerated Approval

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PrecigenGERMANTOWN, Md.Aug. 9, 2023 /PRNewswire/ — Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has agreed that the ongoing Phase 1/2 single arm study (NCT04724980) of the first-in-class investigational PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP) will serve as pivotal for the purpose of filing an accelerated approval request for licensure. The FDA also confirmed no additional randomized, placebo-controlled trial will be required to support submission of a biologics license application (BLA). Based on the FDA guidance, the Company plans to initiate a confirmatory study prior to submission of the BLA.

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techtransfer

The Technology Transfer Society – Washington D.C. Chapter will be offering an Introduction to Technology Transfer and Commercialization Fall 2023 course in conjunction with Montgomery College

By News, News Archive

techtransferThe Technology Transfer Society – Washington D.C. Chapter will be offering an Introduction to Technology Transfer and Commercialization Fall 2023 course in conjunction with Montgomery College. The course will be given in a hybrid format to allow for both virtual and in-person attendance.

This course is intended to provide students with an overview of the entire technology transfer process – moving technologies from the lab to market. This course is a great overview for anyone interested in learning more about the operations of a technology transfer office or those looking to understand how to commercialize their own invention. Students will hear from experienced professionals, including those from federal labs, to broaden their understanding of technology transfer.

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Qiagen250

QIAGEN receives FDA approval for companion diagnostic to Blueprint Medicines’ AYVAKIT® (avapritinib) in gastrointestinal stromal tumors

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Qiagen250QIAGEN’s therascreen PDGFRA RGQ PCR kit approved in U.S. to aid in identifying patients with unresectable or metastatic gastrointestinal stromal tumors positive for the PDGFRA D842V mutation who may be eligible for treatment with AYVAKIT® (avapritinib) // First FDA-approved companion diagnostic to detect mutation in the platelet-derived growth factor receptor alpha gene associated with primary resistance to other drugs // Approval adds to QIAGEN’s leading portfolio in precision medicine, including now 12 FDA approved companion diagnostics

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BHCR Top 3 image

BioHealth Capital Region Achieves Top 3 Ranking: A Triumph of Collaboration and Innovation

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BHCR Top 3 imageIn 2016, during the Annual BioHealth Capital Region Forum at MedImmune/AstraZeneca in Gaithersburg, Maryland, an ambitious goal was set: to make the BioHealth Capital Region (BHCR) a Top 3 BioHealth cluster in the United States by 2023. That vision has been realized in the latest Genetic Engineering & Biotechnology News “Top 10 U.S. Biopharma Clusters” rankings, marking a significant milestone in the region’s relentless pursuit of excellence, collaboration, and innovation in the BioHealth field.

Rich Bendis, President & CEO of BioHealth Innovation, Inc., stated, “It’s been an incredible journey working with so many dedicated individuals and organizations in the region over the years to meet this goal. The spirit of collaboration and innovation that defines the BioHealth Capital Region has been the driving force behind this success, and I’m proud to be part of this remarkable community.”

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AUTM

Record Growth in Research Funding and Startups: Highlights from the 2022 AUTM Licensing Survey

By News, News Archive

AUTMThe Association of University Technology Managers (AUTM) has released its annual Licensing Survey for 2022, revealing promising trends in technology transfer across the United States and Canada. The survey’s findings underscore the significant growth in research funding, the robustness of startup companies, and the evolving landscape of licensing.

U.S. Survey Highlights

In the United States, the survey reported record-breaking research expenditures, topping $91 billion in 2022. This marks a 9.5% increase from the previous year and the highest total in the survey’s 30-year history.

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