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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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Rich and Alex 250 250 px

How the BioHealth Capital Region Became a Top 3 BioPharma Cluster: Insights from Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News

By BioTalk with Rich Bendis Podcast, News

Rich and Alex 250 250 pxHow does a BioPharma Cluster ascend the ranks to secure a Top 3 position? What are the key factors propelling the BioHealth Capital Region to achieve its ambitious goal of ranking 3rd by 2023? Join us in this episode of BioTalk, where our host Rich Bendis speaks with Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News.

In this installment, Alex unveils the intricacies behind his latest Top 10 U.S. Biopharma Clusters, highlighting the impressive rise of the BioHealth Capital Region to its 3rd position. Learn about the origins of these rankings, the trends that have been identified for 2023, and the dynamic shifts within the BioPharma landscape on a regional scale.

Listen now via your favorite podcasting platform:

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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

By News, News Archive

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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biobuzzct

BioBuzz: Catching Up with 2022 Crab Trap Winners Neuroene and Polaris

By News

biobuzzctWith federal funding and solutions that address major risks and aim to improve outcomes for warfighters and civilians, Polaris and Neuroene are set to continue their momentum as showcase companies in the DMV life science scene.

By Sam Hopkins

August 8, 2023

As the BioHealth Capital Region and other life sciences sectors continue to evolve and innovate, it’s crucial for start-ups and entrepreneurs to seize every opportunity to showcase their groundbreaking work. 

One of those incredible opportunities is this year’s 8th Annual BioHealth Capital Region Crab Trap competition, part of the 9th Annual BioHealth Capital Region Forum. This event has evolved significantly over the years, attracting applicants not only from the region but also from across the country and around the world. 

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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

By News, News Archive

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

By News, News Archive

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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Brad and Rich 250 250 px

Navigating Growth and Collaboration in Life Sciences: A Conversation with Brad L. Stewart, SVP of Business Development, MCEDC

By BioTalk with Rich Bendis Podcast, News

Brad and Rich 250 250 pxHow does a region evolve to become a leading driver in the BioHealth Capital Region? What are the secrets behind the successful collaboration between various organizations like MCEDC (Montgomery County Economic Development Corporation), MTC (Maryland Tech Council), and the Maryland Department of Commerce? How does a serial biotech entrepreneur leverage his experience to grow a diverse cross-section of businesses, including life sciences, technology, cybersecurity, defense, and hospitality?

In this episode of BioTalk, host Rich Bendis chats with Brad L. Stewart, SVP of Economic Development for Montgomery County Economic Development Corporation (MCEDC). Brad’s multifaceted career spans from being a Chief Executive Officer to leading expert teams in strategy and innovation, plus economic development specialists in Montgomery County.

Listen now via your favorite podcasting platform:

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BHCR Top 3 image

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

By News, News Archive

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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