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GSK has announced it is investing over £270m to build a new vaccine manufacturing facility at its Wavre campus in Belgium.

The investment follows the launch of the company’s new respiratory syncytial virus (RSV) vaccine, Arexvy.

Designed to increase the efficiency of manufacturing processes and reduce environmental impact, the new unit will handle freeze-dried vaccines, including Arexvy, as well as the company’s fast-growing shingles vaccine, Shingrix, and its malaria vaccine, Mosquirix.

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US-based biotech company VLP Therapeutics, Inc. (VLPT) and its Tokyo-based group company VLP Therapeutics Japan, Inc. (VLPT Japan) together announced on September 5 the second closing of its financing round, which secured investments from two existing investors: MUFG Bank, Ltd., and Miyako Kyoto University Innovation II L.P., as well as two new investors: FFG Venture Business Partners Co., Ltd. and toberu Fund run by Phoenixi Co., Ltd.

With this funding the VLPT group plans to: 1) bolster its vaccine research and development underway in the US for cancer treatment and infectious disease prevention, such as malaria and dengue; and 2) establish a manufacturing facility, which is expected to begin operation in 2024–2025 and will enable VLPT Japan to produce investigational vaccines in-house in Fukuoka, Japan.

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ROCKVILLE, MD, Sept. 05, 2023 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that its partner, Gilead Sciences, Inc. (NASDAQ: GILD), nominated the first of two research programs, leveraging MacroGenics’ DART® and TRIDENT® platforms for generating bispecific antibodies. This nomination grants Gilead an exclusive option, upon achievement of a pre-defined preclinical milestone, to license worldwide rights to the research program.

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Join us for an insightful episode of BioTalk as host Rich Bendis welcomes back Rachel King, the visionary CEO of the Biotechnology Innovation Organization (BIO), bringing with her a remarkable journey spanning roles as an entrepreneur, board member, and advocate for the biotech industry.

In this engaging installment, Rachel offers a glimpse into her evolution from consulting to industry, including her role as co-founder and former CEO of GlycoMimetics, Inc. (GMI). Discover the essence of BIO, its mission, and the global perspective it brings to the biotech landscape. Delve into Rachel's advocacy role and the critical issues facing the industry today, including pricing, congressional relations, and investment challenges. Gain insights into the state of the biotech industry and Rachel's projections for both the near and long term.

Listen as we unravel the dynamic journey of Rachel King, a trailblazing leader in biotechnology, and gain a comprehensive perspective on the industry's present and future. Available now on all major podcasting platforms.

 

Listen now via your favorite podcasting platform:

AmgenHorizon

THOUSAND OAKS, Calif. and DUBLINSept. 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen's acquisition of Horizon.

As a result of the consent order agreement, Amgen and Horizon expect that the parties will jointly file stipulated proposed orders to dismiss the preliminary injunction motion and dissolve the temporary restraining order (TRO) in the U.S. District Court for the Northern District of Illinois, and that Amgen and Horizon will quickly seek the final approvals required under Irish law to close the acquisition.

Narcan

GAITHERSBURG, Md., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions Inc. (NYSE: EBS) announced NARCAN® Naloxone HCl Nasal Spray 4 mg will be available on shelves nationwide and online beginning in September. Over-the-counter (OTC) access to NARCAN® Nasal Spray offers more people the ability to respond in an opioid emergency, helping to save lives and keep loved ones and communities safe. Expanding access and awareness is critical given the staggering toll of the epidemic mainly driven by synthetic opioids, like fentanyl.1 Last year, approximately every seven minutes one life was lost due to an opioid overdose, and today it is the leading cause of accidental death in the U.S.2,3 The average response time for emergency services to arrive is approximately 10 minutes.4 Having NARCAN® Nasal Spray in a first-aid kit, or carrying it on the go in case of an opioid emergency, can make a difference and help reverse the effects of opioids while waiting for emergency personnel to arrive.

Emerald

Los Angeles, CA; September - CellKey, a leading provider of innovative bioanalytical solutions, is thrilled to announce the signing of a Memorandum of Understanding (MOU) with Emerald Cloud Lab (ECL), a pioneer in cloud-based laboratory facilities, to collaborate on the development of a cutting-edge glycoprotein analysis platform. This strategic partnership aims to revolutionize glycosylation studies, essential for diagnosing and treating cancer and various other diseases, as evidenced by the groundbreaking work of the recent Nobel laureate in Chemistry at Stanford University.

tech showcase

The Frederick National Laboratory Advanced Technology Research Facility in Frederick, MD, is set to host the 2023 Technology Showcase on September 6, 2023. This annual event serves as a platform for potential industry partners to engage with the National Cancer Institute (NCI) and Frederick National Laboratory (FNL).

Registration and Attendance

Interested parties can register to attend the showcase either in person or online. Each mode of attendance has its own unique registration link, offering flexibility for participants.

What to Expect

The Technology Showcase is a free hybrid event featuring a variety of activities and opportunities:

  • Inventor Highlights: NCI and FNL inventors will present technologies ripe for commercialization and collaboration.

  • Programmatic Insights: Leaders from NCI and FNL will share avenues for potential collaboration.

  • Partnership Perspectives: The event will provide insights into what partnering with NCI and FNL entails, including viewpoints from companies that have successfully collaborated.

  • Panel Sessions: These will feature success stories and topics relevant to the commercialization of biomedical technology.

  • Lightning Pitch Competition and Poster Session: These segments will spotlight NIH technologies available for co-development or licensing, presented by the NCI Technology Transfer Ambassadors Program.

polaris

Maryland-based veteran-owned biotech company is working to transform mental health care

COLUMBIA, Md. (August 28, 2023) – Charles Cathlin, CEO of Polaris Genomics (TEDCO Portfolio company)TEDCO, Maryland’s economic engine for technology companies, announced its Venture Funds invested $500,000 State Small Business Credit Initiative (SSBCI) funds in Polaris Genomics, a Maryland-based biotech company.

Fierce15

It’s been a tough year for biotech, so how about a little good news? In between all the layoffs, restructurings and last-ditch strategic option hunting, we wanted to take a moment to shine a spotlight on 15 innovative and truly fierce biotechs.

That didn't surprise us, because everyone we talk to in the Fierce Biotech universe tells us that science doesn't stop for the markets. Financing might be a little tough right now, but innovation, breakthroughs and discoveries are all still being made. 

The latest crop of Fierce 15 honorees consists of companies pushing the envelope not only in the lab, in the clinic or on the conference circuit: They are also defining what it means to be a modern biotech company, with modalities ranging from radiopharmaceuticals to cell therapy. Indications as diverse as oncology, neurodegenerative disorders, Pompe disease and even pregnancy complications made the list this year.

Danaher

Danaher’s wide-ranging offerings for the life sciences sector will get broader and deeper with the $5.7 billion acquisition of Abcam, a company that makes reagents and tools used in scientific research, drug discovery, and diagnostics.

According to deal terms announced Monday, Washington, D.C.-based Danaher agreed to pay $24 cash for each Abcam share, which is a modest 2.7% premium to that company’s $23.36 closing stock price on Friday. However, shares had already spiked sharply in June after Abcam announced it would pursue a strategy to increase shareholder value as it fended off attempts by company’s founder and former CEO to wrest control of the business. Abcam also said in June it would explore strategic alternatives, including the potential sale of the company. Abcam said Monday that its process engaged with more than 30 entities, a list that narrowed to 20 potential acquirers before leading to the Danaher acquisition agreement.

LUPUS

WASHINGTONAug. 28, 2023 /PRNewswire/ -- The Lupus Foundation of America and Lupus Canada are pleased to announce Joan Wither, MD, PhD, FRCPC has been awarded the 2023 Lupus Canada Catalyst Award for her study "Interferon and Prediction of Treatment Responses in Lupus Nephritis," focused on interferon (IFN)-induced genes (an inflammatory marker) to predict treatment response in lupus nephritis with a new technique that could be incorporated into routine analysis of kidney biopsies.

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Explore the world of scientific mentorship and education with Dr. Judy Staveley, an accomplished Chief Biotechnologist and STEM advocate. In this episode of BioTalk, Dr. Staveley discusses her journey in supporting young scientists and her roles in organizations like the National Association of Academies of Science (NAAS) and the American Junior Academy of Science (AJAS).  

Discover the upcoming NAAS/AJAS STEM EDUCATION CONFERENCE/FUNDRAISER on September 16th and its impact on inspiring the next generation of innovators. Learn about AJAS's life science support programs that encourage young talents to pursue careers in STEM.  

Dr. Staveley shares insights into STEM education in the BioHealth Capital Region and her personal goals for nurturing young scientists. Join us to uncover the pivotal role of mentorship in shaping the future of STEM.

Listen now via your favorite podcasting platform:

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Rockville, MD – BioHealth Innovation (BHI), a founding member of the BioHealth Capital Region (BHCR), announces its strategic partnership with Big4Bio, an national aggregator of news and developments in the life sciences sector. This collaboration aims to share pivotal news and information from the BHCR, which has recently achieved a significant milestone by ranking as a Top 3 BioPharma Cluster in the Genetic Engineering & Biotechnology News “Top 10 US Biopharma Clusters” rankings, to a larger audience beyond the region.

In an era where the life sciences sector is experiencing unparalleled innovation and investment, staying updated with key information is paramount. Big4Bio, focused on its comprehensive coverage of the cornerstone “Big 4” in biosciences and health - drugs, devices, diagnostics, and digital (the “four D’s”), offers daily email newsletters that provide readers with easy-to-scan headlines sourced from hundreds of credible industry sources across eight US Biotech markets. Their commitment to producing individual summaries for the world’s most significant life sciences markets aligns with BHI’s and the BHCR’s vision of fostering growth and innovation in the biotech and life sciences industries.

Bloomberg Business School

The new 250,000-square-foot facility will support the Bloomberg School's mission through dynamic workspaces, state-of-the-art classrooms, and a variety of study, collaboration, and event spaces.

The Johns Hopkins Bloomberg School of Public Health shared the latest updates on their planned new building at the Baltimore City Urban Design & Architecture Advisory Panel (UDAAP) meeting this morning.

The new building will be located on existing Johns Hopkins property at the corner of McElderry and Washington streets—adjacent to the division's main Wolfe Street building and at the heart of the East Baltimore campus. The school has been working with award-winning, London-based architectural firm Hopkins Architects as design architect and Baltimore-based Hord Coplan Macht Inc. as architect of record to design a facility that will meet the demands of public health education, research, and practice well into the future.

Totaling approximately 250,000 gross square feet across seven floors, the new facility will support the school's mission of inspiring and educating the next generation of public health leaders through dynamic workspaces, state-of-the-art classrooms, and a variety of study, collaboration, and event spaces, including for events and meetings with community groups.

Currently, the school's academic departments have outgrown their existing spaces, primarily comprised of two separate buildings on North Wolfe Street and North Broadway. The new facility will connect to the Wolfe Street building, bring the core activities of all 10 departments together in one location, and accommodate the Bloomberg School's growth. The new building will also add much-needed green space to the campus, including an expansion of the existing School of Nursing courtyard that will provide a shared collegial space for rest and relaxation between the two schools.

"We are thrilled to be able to move this building to the next phase of planning, with a thoughtful design for a modern facility that connects to our current Wolfe Street building, in order to foster interdisciplinary collaboration, enhance our teaching and learning experience, and provide new opportunities for community engagement and convening," said Bloomberg School of Public Health Dean Ellen J. MacKenzie. "Our goal is to create a vibrant space where researchers, practitioners, policymakers, and students collaborate seamlessly to address the most pressing challenges facing us today. We are excited to create an environment that nurtures innovation and incubates ideas that can advance public health globally."

Click here to read more via JHU's HUB.

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ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., a privately held, clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, today announced dosing of the first patient in its Phase 1 clinical trial evaluating ITI-1001, a plasmid DNA (pDNA) vaccine, for the treatment of Glioblastoma Multiforme (GBM), a rare but aggressive form of brain cancer. The study is being conducted at the Dana-Farber Cancer Institute in Boston, Massachusetts and is being led by Dr. David Reardon, Clinical Director, Center for Neuro-Oncology.

“Dosing of the first patient in the Phase 1 clinical trial of ITI-1001 in patients with GBM is a significant clinical development milestone for Immunomic, representing the first time this pDNA vaccine is being administered in humans,” stated Dr. Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics. “We are eager to evaluate the safety and preliminary efficacy in this patient population, who have only limited treatment options for this devastating disease and expect to read out top-line data in the second quarter of 2025.”

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Horizon Therapeutics and Roche rank among the top pharma companies in terms of reputation among rare disease patient groups, according to a recent report compiled by U.K. consultancy PatientView. 

Published Tuesday, the 2022 Corporate Reputation of Pharma survey asked 426 rare disease patient groups representing some 3.3 million patients to assess the performance of 34 drugmakers in the space.

The report noted that pharma has steadily improved its reputation among rare disease patient groups over the past five years. Most respondents praised drugmakers’ abilities to provide products that are beneficial to patients and innovating on breakthrough treatments.

Still, the industry scored lower in 2022 for key activities that are meaningful to these patient populations, including fair pricing policies and access to medicines.

Out of the 34 companies, Horizon was ranked first among rare disease patient groups familiar with the brand, followed by Roche and Takeda Pharmaceuticals. Out of 31 companies, Roche was assessed as the top company by rare disease patient groups working with the company.

Click here to continue reading.

Gillian Henker

We’re excited to introduce you to the always interesting and insightful Gillian Henker. We hope you’ll enjoy our conversation with Gillian below.

Hi Gillian, thanks for joining us today. So let’s jump to your mission – what’s the backstory behind how you developed the mission that drives your brand?

At Sisu Global, we set our vision for a world where medical technology enables access to healthcare in every community. In 2010 at Komfo Anokye Teaching Hospital (KATH), I set out to create medical devices to fit the unmet needs of those in resource-limited settings — medical devices that are simple in nature yet impactful in design, serve as a lifesaving intervention for patients, and directly influence the entire healthcare ecosystem.

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COLUMBIA, Md., August 23, 2023 — Welldoc®, a digital health leader revolutionizing chronic care, today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar® . This clearance immediately follows Welldoc’s 10th 510(k) clearance announcement earlier this month, solidifying the company’s continued leadership in chronic care innovation.

Welldoc’s latest 510(k) enables BlueStar to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. This feature enhances BlueStar’s existing digital coaching capabilities, which guide dietary and lifestyle decisions and assist individuals in self-managing their diabetes. Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin.

HHS logo

Funding includes $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody, and $100 million to explore novel vaccine and therapeutic technologies

Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), awarded more than $1.4 billion for Project NextGen to support the development of a new generation of tools and technologies to protect against COVID-19 for years to come.

The awards announced today follow extensive coordination with industry partners and include support for clinical trials that will enable the rapid development of even more effective and longer-lasting coronavirus vaccines, a new monoclonal antibody, and transformative technologies to streamline manufacturing processes.

“Project NextGen is a key part of the Biden-Harris Administration’s commitment to keeping people safe from COVID-19 variants,” said HHS Secretary Xavier Becerra. “These awards are a catalyst for the program – kickstarting efforts to more quickly develop vaccines and continue to ensure availability of effective treatments.”

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What does it take to pioneer groundbreaking T-cell immunotherapies and vaccines for infectious diseases and cancer? Join us for this episode of BioTalk, where we sit down with Bill Enright, a seasoned biotech executive with a remarkable track record spanning over three decades. Bill brings a wealth of experience in building and financing both privately held and publicly traded companies, making his mark in various roles within the life science/biotech industry.

Bill offers a compelling update in this installment since his previous appearance on BioTalk. Learn about the intriguing journey that led Vaccitech, a clinical-stage T cell immunotherapy and vaccine company, to select Montgomery County, MD, within the thriving BioHealth Capital Region, for its new site. Delve into the intricacies of their pioneering platform, which harnesses the power of immunotherapy to elicit robust T cell responses and antibodies against infectious agents and tumors.

Listen now via your favorite podcasting platform:

Japanvisit

On 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.

Zalgen Labs

FREDERICK, 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.

TEDCONOSTO

COLUMBIA, Md. (August 17, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Social Impact Builder Fund investment of $250,000 into Nostopharma, LLC., a small business developing treatments to restore the health of orthopedic patients.

“Nostopharma is on a mission to revolutionize orthopedic surgery. We hope to offer a complication-free future for trauma patients, athletes and chronic inflammation victims and are developing treatments to help surgeons control trauma complications, including trauma induced abnormal bone growth, a problem that the first application of our platform is looking to solve,” said Ekaterina Vert-Wong, cofounder and CEO of Nostopharma. “We are creating products that minimize abnormal bone growth from the start, helping patients avoid painful and costly revision surgeries.”

linshom medical logo

BALTIMORE, MARYLAND, UNITED STATES, August 15, 2023/EINPresswire.com/ -- Linshom Medical, a Maryland startup medical device company producing innovative advances in respiratory monitoring, received investments of $250K and $400K from Abell Foundation and TEDCO respectively as part of a Series A preferred equity round.

Accurate respiratory monitoring and rapid detection of early respiratory decline are foundational to ensuring positive patient outcomes. Linshom is first to deliver operating room (OR) quality respiratory data to the patient’s bedside. Patients on the general care floor, in the emergency room, in the post anesthesia care unit, and at home do not have the quality of monitoring available in the OR or intensive care unit (ICU). Those technologies are too big, complex and expensive for bedside use. Linshom addresses these barriers by delivering a small, low cost, wearable sensor that delivers highly accurate, continuous, predictive respiratory monitoring (CPRM) to the patient’s bedside.

MyMD250

BALTIMORE--()--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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How 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:

biobuzzct

With 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. 

Georgiamune

GAITHERSBURG, 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.

Precigen

GERMANTOWN, 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.

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. 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.

10XAdd

NEW 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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How 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:

BHCR Top 3 image

In 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.”