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620th Edition, August 6, 2024

By BHI Weekly News Archives

 

Exploring ARPA-H Innovations: Insights with Craig Gravitz and Jenica Patterson, Ph.D. on BioTalk 

In this episode of BioTalk, Rich Bendis, President and CEO of BioHealth Innovation, Inc., welcomes guests from ARPA-H: Craig Gravitz, Director of the Project Accelerator Transition Innovation Office (PATIO), and Jenica Patterson, Ph.D., Portfolio Lead at ARPA-H. Together, they provide a comprehensive overview of ARPA-H’s mission and innovative programs.

Craig Gravitz and Jenica Patterson share their educational and career backgrounds, setting the stage for a discussion about ARPA-H and its various initiatives. They provide insights into how ARPA-H differentiates itself from other agencies like HHS and NIH, while also highlighting their collaborative efforts.

Listen now via your favorite podcast platform:

Apple: https://apple.co/4dy5wmS
Spotify: https://spoti.fi/3yDIV9k 
Amazon Music: https://amzn.to/3AcL3FI 
TuneIn: https://bit.ly/3LV54Dg

Listeners will learn about the Project Accelerator Transition Innovation Office (PATIO) and its crucial role within ARPA-H. Jenica Patterson discusses her portfolio, including key areas and projects, and provides details on the new women’s sprint for health initiative and its funding tracks.

In this episode of BioTalk, Rich Bendis, President and CEO of BioHealth Innovation, Inc., speaks with Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News. Alex joins the podcast to discuss the latest Top 10 U.S. Biopharma Clusters list, where the BioHealth Capital Region secured its #3 ranking for the second consecutive year.

The conversation highlights the factors that contributed to the success of the top biopharma clusters, focusing on early investments in biotech, the generation of high-quality science, building networks with partners, and broadening clusters beyond anchor businesses. Alex elaborates on how these regions have sustained their scientific excellence and the long-lasting impact of pioneering efforts.

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BioHealth Capital Region Retains #3 Spot in GEN’s Top U.S. Biopharma Clusters for 2024

The BioHealth Capital Region (Maryland, Virginia, and Washington, D.C.) has successfully retained its position as the #3 biopharma cluster in the U.S. for 2024. This impressive ranking underscores the region’s ongoing strength in innovation and investment, highlighted by major expansions and investments from leading companies and institutions. Despite facing some challenges, the region continues to lead in patents, NIH funding, and lab space.

From 

Alex Philippidis’ remarks:

The BioHealth Capital Region has generated enough positive news to retain the number-three ranking it earned and celebrated last year. QIAGEN and Frederick County, MD, officials on July 12 announced completion of a 40,000-square-foot expansion of the company’s Frederick, MD, facility, creating a 75,000-square-foot site focused on next-generation sequencing, genomics, clinical healthcare, and forensics. AstraZeneca is investing $300 million in a new manufacturing facility in Rockville, MD, with plans to create 150 new jobs when the site opens in 2026. Across the state line, The University of Virginia is constructing the $300 million Paul and Diane Manning Institute of Biotechnology in Charlottesville; named for chairman and CEO of PBM Capital and his wife.

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Montgomery County Council Approves Great Seneca Plan: Connecting Life and Science

ROCKVILLE, Md., July 30, 2024—The Montgomery County Council voted today to approve the Planning Board Draft of the Great Seneca Plan: Connecting Life and Science with revisions. The plan covers 4,330 acres located in the heart of the I-270 Corridor between the cities of Gaithersburg and Rockville and the town of Washington Grove. The Plan makes recommendations to strengthen the economic competitiveness of the Life Sciences Center, guide future developments, and transform public spaces and amenities in the area to provide valuable links and social spaces. 

“The Great Seneca Science Corridor is one of Montgomery County’s most important strategic areas, as the heart of our globally recognized biohealth industry with world-class research, education, and health care facilities,” said Council President Andrew Friedson who also chairs the Planning, Housing and Parks (PHP) Committee. “This plan builds on that strength by creating a more sustainable and vibrant community with greater connectivity to improve quality of life and economic competitiveness.”

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Theriva™ Biologics Receives Rare Pediatric Drug Designation by the U.S. FDA for VCN-01 for the Treatment of Retinoblastoma

ROCKVILLE, Md., July 31, 2024 (GLOBE NEWSWIRE) — Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Drug Designation (RPDD) for VCN-01 for the treatment of retinoblastoma. VCN-01, Theriva’s lead product candidate, is a systemic, selective, stroma-degrading oncolytic adenovirus. Previously, the FDA granted orphan drug designation to VCN-01 for treatment of retinoblastoma.

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Sirnaomics Announces a Partnership with Gore Range Capital for Establishment of a JV, Sagesse Bio, to Advance Its RNAi Therapeutics into Aesthetic Medicine

HONG KONG, GERMANTOWN, Md. and SUZHOU, China, July 31, 2024 /PRNewswire/ — Sirnaomics Ltd. (the “Company“, Stock Code: 2257.HK, together with its subsidiaries, the “Group” or “Sirnaomics“), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, today announced a partnership with Gore Range Capital LLC (“Gore Range Capital“) (Dallas, TX, USA) for establishment of a joint venture, Sagesse Bio, Inc., to advance its novel RNAi therapeutic products into aesthetic medicine.

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Emergent BioSolutions Completes Sale of RSDL® (Reactive Skin Decontamination Lotion) Kit to SERB Pharmaceuticals for $75 Million

GAITHERSBURG, Md., July 31, 2024 (GLOBE NEWSWIRE) — Today, Emergent BioSolutions Inc. (NYSE: EBS) announced the sale of RSDL® (Reactive Skin Decontamination Lotion) kit to SERB Pharmaceuticals, a global pharmaceutical company, for a purchase price of approximately $75 million. In addition, SERB will pay Emergent a $5 million payment upon achievement of a milestone related to the sourcing of a certain component of RSDL®. The transaction has signed and closed simultaneously. 

In addition, SERB will acquire and maintain operations of Emergent’s leased manufacturing facility in Hattiesburg, Mississippi, and several site-based employees who support RSDL® will join SERB. SERB will also acquire the RSDL® product inventory as part of the transaction and will assume certain related contracts. Emergent’s Winnipeg facility will continue to manufacture and supply bulk lotion to SERB under a long-term supply agreement between the two companies.

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Georgiamune Announces First Patient Dosed in A First-In-Class Phase 1 Cancer Treatment Trial of GIM-531

GAITHERSBURG, Md., July 30, 2024 (GLOBE NEWSWIRE) — Today, Georgiamune Inc., a privately held, clinical-stage biotechnology company, announced that the first patient has been dosed with GIM-531 in a first-in-human, phase 1 clinical trial for the treatment of advanced cancer patients. GIM-531 development focuses on indications that are currently not addressed with existing or available immunotherapies including anti-PD-1 antibodies. It is an oral therapy that is a first-in-class selective T regulatory cell inhibitor.

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PMLIVE: GSK and Flagship Pioneering partner in deal worth up to $7bn to discover medicines and vaccines

GSK and Flagship Pioneering have entered into a partnership worth up to $7bn to discover and develop novel medicines and vaccines for a range of conditions.

Bringing together GSK’s expertise in disease and development capability via Flagship’s ecosystem of bioplatform companies, the collaboration aims to develop a portfolio of up to ten future medicines and vaccines, beginning in respiratory and immunology, which will each be subject to an exclusive option by GSK for further clinical development.

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WBJ: Metro, Montgomery County partner for major North Bethesda development

By Dan Brendel – Staff Reporter, Washington Business Journal -Jul 29, 2024 – Montgomery County and Metro have announced a formal partnership and preliminary developer solicitation to pave the way for up to 3.7 million square feet of life science-focused mixed-used development in North Bethesda, the economic development apple of Montgomery County’s eye.

The county and transit authority signed a memorandum of understanding and announced a request for qualifications on Monday, beginning the hunt for a development partner to build a University of Maryland-anchored project, integrated with a new North Bethesda Metro station entrance, on 14 noncontiguous acres of vacant Metro-owned land at the southeast corner of Rockville Pike and Old Georgetown Road.

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Frederick’s Tonix Pharmaceuticals Awarded Up to $34 Million U.S. Department of Defense Contract for Accelerated Development of Broad-Spectrum Antiviral Program

FREDERICK, Md., July 29, 2024 /PRNewswire-PRWeb/ — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced it has been awarded an Other Transaction Agreement (OTA) with a potential for up to $34 million over five years by the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense (DoD). The objective of the contract is to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments.

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619th Edition, July 30, 2024

By BHI Weekly News Archives

BioHealth Capital Region Maintains #3 Ranking: Insights with GEN’s Alex Philippidis on BioTalk 

In this episode of BioTalk, Rich Bendis, President and CEO of BioHealth Innovation, Inc., speaks with Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News. Alex joins the podcast to discuss the latest Top 10 U.S. Biopharma Clusters list, where the BioHealth Capital Region secured its #3 ranking for the second consecutive year.

The conversation highlights the factors that contributed to the success of the top biopharma clusters, focusing on early investments in biotech, the generation of high-quality science, building networks with partners, and broadening clusters beyond anchor businesses. Alex elaborates on how these regions have sustained their scientific excellence and the long-lasting impact of pioneering efforts.

Listening now on your favorite podcast platforms:
Apple: https://apple.co/4bYl81G 
Spotify: https://spoti.fi/3zVLIuU
Amazon Music: https://amzn.to/4d6dBiQ
TuneIn:https://bit.ly/4fBDs3R

 

 

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BioHealth Capital Region Retains #3 Spot in GEN’s Top U.S. Biopharma Clusters for 2024

The BioHealth Capital Region (Maryland, Virginia, and Washington, D.C.) has successfully retained its position as the #3 biopharma cluster in the U.S. for 2024. This impressive ranking underscores the region’s ongoing strength in innovation and investment, highlighted by major expansions and investments from leading companies and institutions. Despite facing some challenges, the region continues to lead in patents, NIH funding, and lab space.

From 

Alex Philippidis’ remarks:

The BioHealth Capital Region has generated enough positive news to retain the number-three ranking it earned and celebrated last year. QIAGEN and Frederick County, MD, officials on July 12 announced completion of a 40,000-square-foot expansion of the company’s Frederick, MD, facility, creating a 75,000-square-foot site focused on next-generation sequencing, genomics, clinical healthcare, and forensics. AstraZeneca is investing $300 million in a new manufacturing facility in Rockville, MD, with plans to create 150 new jobs when the site opens in 2026. Across the state line, The University of Virginia is constructing the $300 million Paul and Diane Manning Institute of Biotechnology in Charlottesville; named for chairman and CEO of PBM Capital and his wife.

Read More

 

WBJ: JLL experts explore the future and changes of life sciences real estate in D.C.

In the rapidly evolving world of life sciences, the real estate sector is experiencing significant shifts and opportunities. JLL’s latest report, U.S. Life Sciences Property Report, explores the dynamics of leasing, occupancy rates and market conditions.

To learn more about the life sciences market in Washington, D.C., we sat down with local experts, JLL Research Manager Kate Paine and Executive Managing Director Pete Briskman to delve deeper into these trends and gain valuable insights.

In the D.C. market, how have lease terms in the life sciences sector changed over time and what factors have influenced these changes?

Mirroring national leasing trends, lease terms in the D.C. market are shortening, especially among new leases and relocations. The average lease term for new leases (non-renewals) has fallen to just over five years, down from nearly 10 years in 2022. Shortening of lease term is a response to supply outpacing demand, which is giving the leverage back to tenants and allowing startups and pre-revenue tenants to negotiate for shorter terms. A key contributor to shortening lease terms over the past few years is the influx of spec suites that have delivered to the market, which are designed to be flexible space options for early-stage companies.

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BioHealth Innovation Celebrates Solaxa Inc.’s Recent TEDCO Investment

BioHealth Innovation, Inc. (BHI) proudly recognizes the $500,000 investment from TEDCO in Solaxa Inc., a Bethesda-based biopharmaceutical company. Led by Founder & CEO Christian Walker, Solaxa is a clinical-stage biopharmaceutical company developing a portfolio of aminopyridine drugs that both detect and treat ion channel dysfunction. Previous research has shown that aminopyridines can improve nerve signaling and muscle function in patients with Multiple Sclerosis, and Solaxa is presently researching additional benefits in patients with other nerve disorders. Solaxa is organized as a for-profit public benefit corporation, with a mission to advance scientific knowledge and deliver impactful and accessible therapies that improve outcomes for patients worldwide.   

Prior to this investment from TEDCO, Solaxa was recognized as the “Best of Montgomery” finalist at the 7th Annual BioHealth Capital Region Crab Trap Pitch Competition in September 2023. Even more recently, Solaxa was recognized as “Venture of the Year” by the Maryland Tech Council in May 2024.  

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Adventist HealthCare Names BHI Board Member John Sackett President and CEO

Gaithersburg, Md. – Adventist HealthCare has named John Sackett as its next president and CEO, effective Aug. 4, 2024.

Sackett has served as Adventist HealthCare’s chief operating officer since 2014 and served as president of Adventist HealthCare Shady Grove Medical Center from 2013–2019. During his tenure, Sackett helped launch Adventist HealthCare’s Leadership System and its Standard Management Approach that earned a Malcolm Baldrige Category Best Practice Recognition, one of the nation’s highest honors for performance excellence. He also guided the system’s expansion of comprehensive care through the integration of additional acute care hospitals and significant campus improvement projects.

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Emmes Group partners with Miimansa AI to accelerate adoption of Generative AI in clinical research

ROCKVILLE, Md., July 23, 2024 /PRNewswire/ — Emmes Group, a leading specialty tech-enabled global contract research organization (CRO), today announced a multi-year strategic partnership with Miimansa AI. A critical pillar of the partnership, aimed at revolutionizing clinical research at Emmes, is the acquisition of Miimansa’s Clinical Entity Modeling tools based on advanced large language modeling (LLM) techniques and generative AI.

Artificial intelligence (AI) promises to transform all aspects of healthcare including clinical research. Emmes Group is rapidly maturing its technology platform, Veridix AI, and Miimansa’s Clinical Entity Modeling technology will serve as a critical building block to accelerate the development of state-of-the-art automated text processing solutions tailored for clinical research.

 

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George Mason researchers lead breakthrough study to find functional cure for HIV

July 25, 2024 / By Laura Powers: Researchers in George Mason University’s Center for Infectious Disease Research (CIDR) and Tulane National Primate Research Center conducted a breakthrough proof-of-concept study, published in Nature’s Gene Therapy, that found a human immunodeficiency virus (HIV)-like virus particle that could cease the need for lifelong medications. Scientists have made great strides in the treatment of HIV over the past few decades, yet those with the virus must still take antiretroviral therapy for life as the disease is difficult to eradicate. 

CIDR researchers led by Yuntao Wu, a professor in George Mason’s School of Systems Biology and the principal investigator of the National Institutes of Health-funded study, developed a special HIV-like virus particle, called HIV Rev-dependent lentiviral vector, that uses an HIV protein, Rev, as a trigger to selectively target and activate therapeutic genes in HIV-infected cells.

The Mason team, including Brian Hetrick, Mark Spear, Jia Guo, Huizhi Liang, Yajing Fu, Zhijun Yang, and Ali Andalibi, has been developing the HIV Rev-dependent vector technology since 2002. 

According to Wu, patients need to take medications for the rest of their lives because of the persistence of HIV reservoirs, which are infected immune cells harboring the virus. Currently, antiretroviral therapy used by patients can effectively block the virus but cannot eliminate the viral reservoirs. Experimental approaches such as “shock and kill” and “block and lock” of the reservoirs have been in development to either eliminate or silence viral reservoirs.

Click here to continue reading. 

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TEDCO Invests in Azadi Health

COLUMBIA, Md., (July 29, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $100,000 Pre-Seed Builder Fund investment in Azadi Health. TEDCO’s Pre-Seed Builder Fund is housed under TEDCO’s Social Impact Funds which were created to engage and invest in economically underserved founders and communities.

“At Azadi, we are committed to creating a solution to allow marginalized communities more effective and accessible access to mental health care,” said Rodney Bell, co-founder and CEO of Azadi Health. “Thanks to TEDCO’s investment, we look forward to continuing this journey to provide improved care to all.”

Azadi Health, located in Baltimore, Md., is a company developing technology-based tools to support better access to mental health care. Taking decades of research in language, psychology, machine learning and data science, the company has created a tool that could provide a more accessible and effective solution for monitoring patients who may be a risk to themselves or others. Through this support the company aims to enable care teams and caretakers to intervene faster when needed.

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Precigen Appoints Phil Tennant as Chief Commercial Officer to Spearhead First Potential Gene Therapy Launch

GERMANTOWN, Md., July 23, 2024 /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 the appointment of Phil Tennant as the Company’s chief commercial officer. Mr. Tennant will be responsible for commercial strategy and execution across US and global markets. His initial focus will be on driving commercial readiness activities for the potential launch of the first- and best-in-class PRGN-2012 AdenoVerse gene therapy in recurrent respiratory papillomatosis (RRP). Mr. Tennant will report to Precigen’s President and CEO, Helen Sabzevari, PhD, and will join Precigen’s executive leadership team.

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TEDCO Announces SSBCI Investment in Solaxa Inc.

Maryland-based biopharmaceutical company receives funding from TEDCO’s Venture Funds’

COLUMBIA, Md., (July 23, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 investment in Solaxa Inc. This investment is from TEDCO’s Venture Funds, with $200,000 being allocated from the State Small Business Credit Initiative (SSBCI) funding.

“At Solaxa, we are developing neurorestorative treatments for children and adults suffering from rare neurodegenerative diseases and acute nerve injuries,” said Christian Walker, CEO and founder of Solaxa. “Thanks to TEDCO’s investment, we can accelerate our work to serve patients with spinocerebellar ataxias for whom our first drug has already been shown to deliver significant clinical improvement in gait, balance and speech.”

Read More

 
Discover Innovation at the 2024 NCI Technology Showcase

The National Cancer Institute’s (NCI) Technology Transfer Center invites you to the 2024 Technology Showcase on September 4th, at the Frederick National Laboratory Advanced Technology Research Facility in Frederick, MD. This free, in-person event will present a remarkable lineup of cutting-edge technologies ready for commercialization. Industry experts will share their insights through engaging presentations, panel discussions on successful collaborations, and a competitive poster session highlighting innovative research.

Attendees will have the opportunity to connect with industry leaders, investors, and entrepreneurs, fostering meaningful networking and potential partnerships. The keynote speaker, Steven Walker, will deliver a compelling address on the future of biotechnology and its impact on cancer research.

The event is an exceptional platform for biotech stakeholders to discover new technologies and explore collaborative ventures. Whether you’re a company, investor, or entrepreneur, the 2024 Technology Showcase offers invaluable insights and connections.

Read More

 
BioBuzz: Growth of Early-Stage Resident Companies Marks the Third Anniversary of Johnson & Johnson Innovation – JLABS @ Washington, DC

In celebration of the three-year anniversary of JLABS @ Washington, DC (JLABS DC), it’s great timing to highlight recent accomplishments and milestones reached by incubating and regional companies. Additionally, JLABS DC is excited to share new access to specialized lab equipment to support more innovators within the region. 

Since the start of 2024, there has been continued success for incubating companies that reside at JLABS DC. Examples with recent funding announcements include Nanochon, raising $4 million in a Series Seed Prime, Acclinate closing $7 million in a Series A round, and Tiny Cargo securing investment from Virginia Ventures Partners. 

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Washington DC’s 60 Degrees Pharmaceuticals Awarded Contract with U.S. Army for ARAKODA® Supply Chain Upgrade Support

WASHINGTON, July 25, 2024 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that it has been awarded a fixed-price contract with the United States Army Medical Materiel Development Activity to support commercial validation of new bottle and replacement blister packaging of ARAKODA® (tafenoquine), the Company’s malaria prevention product.

This follows the implementation of an increased tablet compression batch size in Q1 2024, planned in anticipation of increasing sales volume in 2024. Recently, 60 Degrees Pharmaceuticals announced that Q1 2024 ARAKODA net sales revenues increased 515% year-over-year to $105.7 thousand.

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Maryland Global Consulting Program – Unlocking Your Business’s Global Potential

Ready to take your business to the global stage? Join the Maryland Global Consulting Program through the Robert H. Smith School of Business Center for Global Business and tap into the vibrant export ecosystem right here in Maryland. Gain invaluable insights and resources to expand your company’s global footprint and tackle international business challenges head-on.

Benefits of the Program

  1. Customized Consulting Support: Work closely with a dedicated team of business students to develop strategies for global market expansion or address specific international business challenges tailored to your company’s needs. Student teams dedicate a minimum of 10 hours per week per semester to a single consulting project. 

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Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2024
All Rights Reserved.

 
 

 

 
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618th Edition, July 23, 2024

By BHI Weekly News Archives

 

 

 

Life Sciences Real Estate and Talent Trends: Insights from Matt Gardner, Head of Life Sciences, Americas, CBRE on BioTalk 

In this episode of BioTalk, Rich Bendis, President and CEO of BioHealth Innovation, Inc., speaks with Matt Gardner, Head of Life Sciences, Americas, at CBRE. With over 30 years of experience in the technology and life sciences sectors, Matt Gardner provides a comprehensive look at the latest trends and developments in the life sciences industry.

Matt shares key findings from CBRE’s recently released U.S. Life Sciences Talent Trends’ report for 2024, offering insights into what the life sciences sector can expect in the coming year. He discusses the national real estate market, highlighting the differences between office space and life science wet lab space, and emerging trends in the sector.

The conversation explores the strategic importance of the BioHealth Capital Region (BHCR), consistently ranked as a top market for life sciences research talent. Matt elaborates on what makes this region crucial for CBRE and the life sciences sector as a whole.

Listen now via your favorite podcast platform:
Apple: https://apple.co/4bSOnmo
Spotify: https://spoti.fi/4bVsX8r 
Amazon Music: https://amzn.to/3zLNbUw 
TuneIn: https://bit.ly/2M60Wmx

 

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Elevate Your Startup: Apply to Compete in the 9th Annual Crab Trap Competition

Are you ready to showcase your company to some of the top minds in the industry? The 9th Annual Crab Trap competition, a highlight of the annual BioHealth Capital Region Week, is now accepting applications from emerging companies eager to demonstrate their groundbreaking solutions. Scheduled for September 18th at the US Pharmacopeia in Rockville, MD, this competition is an unmissable opportunity for startups looking to make a significant impact.

A Platform for Pioneers

The Crab Trap provides a unique platform for startups to present their innovations before a panel of esteemed judges and a live audience. This year’s competition promises exciting prizes, including cash and business services, to accelerate the winning entry’s growth and success.

Why Enter Crab Trap?

Participating in the Crab Trap competition offers numerous benefits:

  • Visibility: Gain exposure to a broad audience of industry professionals, investors, and potential partners.
  • Feedback: Receive valuable insights and feedback from leaders in the biohealth industry.
  • Prizes: Compete for a chance to win cash and services that can catalyze your company’s growth and development.

Apply Now

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Forbes: Meet The New Biotech Billionaire Putting Pig Hearts In Humans

In 1996, Martine Rothblatt’s six-year-old daughter was diagnosed with pulmonary arterial hypertension, a rare lung and heart disease without a cure. Undeterred, Rothblatt, a cofounder of Sirius Satellite Radio, launched her own biotech firm with the goal of finding one.

“There is nothing worse than being told that your daughter is going to die.” Forbes in 2018. “I just said I will find a way, or she was going to die, because all of the previous people with this illness had died.”

Nearly three decades later, Rothblatt’s daughter is healthy and in her 30s. Meanwhile, shares of the now publicly traded firm, United Therapeutics, are up 54 times its price at its 1999 IPO. This year alone, shares have surged, up 50% so far in 2024 and up 40% since April 30—enough to make Rothblatt the world’s newest billionaire.

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Children’s National Innovational District: Closing the ‘Valley of Death’: Pioneering – and paying for – new therapies

With the advent of life-changing cell and gene therapies (CGTs) to treat pediatric diseases, price is becoming a significant obstacle to care and cures.

Successful therapies can wind up shelved or in hard-to-reach clinical trials for a litany of reasons: high manufacturing costs, significant regulatory burdens, a lack of enthusiasm from the pharmaceutical industry in the small pediatric market and the simple fact that insurance companies resist paying the price of $1 million or more for a therapeutic. When successful treatments are set aside and become victims of this market failure, leaders in pediatric medicine say the drug has been relegated to the “Valley of Death.”

Experts at Children’s National Hospital and other leading U.S. research institutions are working to ferry drugs across it.

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Gaithersburg’s Shuttle Pharma’s new drug shows promise against estrogen receptor-positive breast cancer

Shuttle Pharma’s Selective HDAC Inhibitor Exhibits ATM Activation and Modulation of ER Expression Resulting in Substantial Growth Inhibition of Estrogen Receptor Positive Breast Cancer Cells, as Reported in PLOS ONE

GAITHERSBURG, Md., July 19, 2024 (GLOBE NEWSWIRE) — Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today announced the publication of a manuscript reporting on the ability of one of the Company’s HDAC inhibitor pre-clinical assets, SP-1-303, which exhibits ataxia-telangiectasia mutated protein (ATM) activation and modulation of estrogen receptor expression resulting in substantial growth inhibition of estrogen receptor positive breast cancer cells (ER + BC).

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Embracing Home as a Health Care Hub: FDA’s Virtual Stakeholder Listening Session

On July 25, 2024, the FDA will host a significant virtual public meeting, “Home as a Health Care Hub – Stakeholder Listening Session,” from 12:00 PM to 4:00 PM ET. This session aims to explore how integrating home environments into the healthcare system can enhance health equity and patient care. The FDA seeks input from various stakeholders to identify both barriers and opportunities in this integration. Additionally, the initiative includes developing VR prototypes for managing conditions like diabetes.

Stakeholders are encouraged to register, participate, and submit comments or presentations ahead of the event.

For more information and registration details, Click here.

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Discover Innovation at the 2024 NCI Technology Showcase

The National Cancer Institute’s (NCI) Technology Transfer Center invites you to the 2024 Technology Showcase on September 4th, at the Frederick National Laboratory Advanced Technology Research Facility in Frederick, MD. This free, in-person event will present a remarkable lineup of cutting-edge technologies ready for commercialization. Industry experts will share their insights through engaging presentations, panel discussions on successful collaborations, and a competitive poster session highlighting innovative research.

Attendees will have the opportunity to connect with industry leaders, investors, and entrepreneurs, fostering meaningful networking and potential partnerships. The keynote speaker, Steven Walker, will deliver a compelling address on the future of biotechnology and its impact on cancer research.

The event is an exceptional platform for biotech stakeholders to discover new technologies and explore collaborative ventures. Whether you’re a company, investor, or entrepreneur, the 2024 Technology Showcase offers invaluable insights and connections.

Read More

 

Capra Biosciences Lands $7.5 Million Project Agreement To Demonstrate Platform To Rapidly Scale Pharmaceutical Ingredient Manufacturing

BioMaP-Consortium Project Agreement Will Combine Sustainable Biochemical Production with AI To Demonstrate a Scalable Platform for the Quick Manufacture of Pharmaceutical Ingredients.

STERLING, Va., July 19, 2024 (GLOBE NEWSWIRE) — Many ingredients that make up the pharmaceuticals Americans rely on are manufactured overseas. When supply chain issues or shortages occur, as witnessed during the COVID pandemic, it can negatively impact millions of Americans and affect national security. The White House issued an Executive Order in 2022 to stimulate U.S. biomanufacturing. Increasing American biomanufacturing, will provide more control over pharmaceutical production, boost the economy, and encourage creation of greener manufacturing methods.

Under a new $7.5 million, two-year project agreement awarded to Capra Biosciences through the BioMaP-Consortium, Capra will demonstrate the ability of its platform to rapidly scale and manufacture biologically derived small molecule active pharmaceutical ingredients (APIs). Capra has a demonstrated history of using its biofilm-forming microbes and proprietary bioreactors to transform low-cost feedstocks into a variety of chemicals, including their first commercial product, retinol.

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Danaher Announces Two New Centers of Innovation in Diagnostics to Transform Precision Medicine Development

WASHINGTON, July 17, 2024 /PRNewswire/ — Danaher Corporation (NYSE: DHR) (“Danaher”), a global science and technology innovator, announced the launch of two new Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP)-certified labs intended to accelerate the development of Companion Diagnostics (CDx) and Complementary Diagnostics (CoDx).

“Our investments in these centers of innovation uniquely position Danaher as a global connector across the innovation ecosystem, leveraging diagnostic technology to simplify and speed pharma translational research,” said Julie Sawyer Montgomery, Executive Vice President at Danaher. “I am excited about this new way of potentially enabling our partners to more quickly bring precision treatments to market – ultimately benefiting more patients everywhere.” 

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FDA Rare Disease Innovation Hub to Enhance and Advance Outcomes for Patients

By: Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research and Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research

An estimated 10,000+ rare diseases affect more than 30 million people – approximately one out of every 10 people – in the U.S., and about half of these people are children. Many rare conditions are life threatening, and most do not have approved treatments. Fundamental to the mission of the U.S. Food and Drug Administration is to engage patients and caregivers – to understand their unique perspectives and experiences and keep these front of mind as we review medical products for rare disease patients.

The Rare Disease Innovation Hub
Recent rapid advances in the identification of promising drug targets and development of gene therapies offer momentum and potential to meet the needs of patients with rare diseases. In 2023, over half of all the novel drugs and biologics approved by the FDA’s Center for Drug Evaluation and Research (CDER) and the FDA’s Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease or condition.

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WBJ: D.C. maternal mental health startup Seven Starling raises $11M Series A round

D.C.-based maternal mental health startup Seven Starling has raised $10.9 million in an oversubscribed round to expand its virtual care services — which include supporting postpartum, early parenthood, infertility, miscarriage and loss and other experiences — further across the country.

San Francisco women’s health-focused venture firm RH Capital led the round and existing investors Menlo Park, California’s Pear VC; San Francisco’s Expa; Santa Monica, California’s Magnify Ventures; Palo Alto, California’s Emerson Collective; and Emeryville, California’s Inflect Health also took part.

Emerson Collective is led by Laurene Powell Jobs, who is an investor in D.C.’s Monumental Sports & Entertainment, the owner of the Washington Wizards, Capitals, Mystics and other sports ventures. Emerson counts The Atlantic magazine, which is based in the District, among its holdings.

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617th Edition, July 16, 2024

By BHI Weekly News Archives

Strengthening Ties: U.S.-Tunisia Cooperation in Science and Technology with Ambassador Joey R. Hood on the BioTalk Podcast 

In this episode of BioTalk with Rich Bendis, we have the honor of speaking with the U.S. Ambassador to the Republic of Tunisia, Joey R. Hood. With an impressive diplomacy and international relations background, Ambassador Hood sheds light on the vital collaboration between the U.S. and Tunisia in scientific research, innovation, and technology transfer.

Ambassador Hood discusses the current status of U.S.-Tunisia cooperation in scientific research and technology transfer, emphasizing these areas’ critical role in Tunisia’s development. He highlights the importance of scientific research, innovation, and technology transfer in Tunisia and explains how the U.S. can support and enhance these efforts.

Click here to listen via your favorite Podcast platform:

Apple: https://apple.co/4cX1YKr
Spotify: https://spoti.fi/4cG6xJt
Amazon Music: https://amzn.to/3WneYDC
T
uneIn: https://bit.ly/2M60Wmx

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BioHealth Capital Region Week 2024 Registration Now Open

Join us this September for the BioHealth Capital Region Week 2024, a gathering that epitomizes the spirit of innovation in the biopharma industry. Hosted once again at US Pharmacopeia in Rockville, MD, from September 17th, 18th, and 19th, 2024, this event is made possible by the generous support of our sponsors, ensuring it remains free for all attendees. This year, we are featuring three cornerstone events: the 10th Annual BioHealth Capital Region Forum, the 9th Annual Crab Trap Competition, and the 7th Annual Investment Conference. Each event is tailored to foster unique opportunities for networking, learning, and investment, drawing together industry leaders, innovators, and investors from across the nation. We extend our heartfelt thanks to US Pharmacopeia for hosting us and to our sponsors whose contributions are vital in making these gatherings accessible to all. Click here to register and apply.

A Decade of Advancement and Achievement

This year marks the 10th anniversary of the BioHealth Capital Region Forum, and we are celebrating a decade of advancements that have positioned our region at the forefront of the biopharma industry. The Forum, spanning the first two days (September 17-18), will feature a lineup of speakers who are pioneers and thought leaders in the industry. Attendees will gain invaluable insights through keynote speeches, panel discussions, and sessions that delve into the latest innovations and trends shaping healthcare and biopharmaceuticals.

Crab Trap Competition: Where Innovation Meets Opportunity

The excitement peaks on September 18th with the 9th Annual Crab Trap Competition. This event showcases emerging companies as they pitch groundbreaking solutions to a panel of esteemed judges for a chance to win significant funding and support. It’s not just a competition; it’s a launchpad for the next generation of BioHealth innovations, providing startups with the visibility they need to attract investors and partners.

Connecting Innovators with Investors

The week concludes with the 7th Annual Investment Conference on September 19th, a must-attend for startups seeking investment and investors looking for the next big thing in BioHealth. This conference facilitates direct connections between up-and-coming companies and seasoned investors through curated meetings, fostering a dynamic environment for deal-making and partnership formation.

 

Read More

 

Elevate Your Startup: Apply to Compete in the 9th Annual Crab Trap Competition

Are you ready to showcase your company to some of the top minds in the industry? The 9th Annual Crab Trap competition, a highlight of the annual BioHealth Capital Region Week, is now accepting applications from emerging companies eager to demonstrate their groundbreaking solutions. Scheduled for September 18th at the US Pharmacopeia in Rockville, MD, this competition is an unmissable opportunity for startups looking to make a significant impact.

A Platform for Pioneers

The Crab Trap provides a unique platform for startups to present their innovations before a panel of esteemed judges and a live audience. This year’s competition promises exciting prizes, including cash and business services, to accelerate the winning entry’s growth and success.

Why Enter Crab Trap?

Participating in the Crab Trap competition offers numerous benefits:

  • Visibility: Gain exposure to a broad audience of industry professionals, investors, and potential partners.
  • Feedback: Receive valuable insights and feedback from leaders in the biohealth industry.
  • Prizes: Compete for a chance to win cash and services that can catalyze your company’s growth and development.

Apply Now

Read More

 
Maximize Your Impact: Sponsorship Opportunities at the 10th Annual BioHealth Capital Region Forum

As we gear up for the 10th Annual BioHealth Capital Region Forum on September 17th-18th, 2024, at the US Pharmacopeia in Rockville, MD, we invite your organization to become a sponsor. This year’s forum marks a decade of innovation and collaboration within the biohealth sector and offers unique sponsorship opportunities that promise substantial visibility and engagement. You can become a sponsor with unique new sponsorship opportunities this year, including “Lunch Sponsor” and “Reception Sponsor” for both days.

Sponsoring the forum ensures that your organization’s logo will be prominently displayed on all event materials, daily presentation decks, and standees positioned strategically throughout the venue. This visual branding extends throughout the event, ensuring your message reaches all attendees. Furthermore, all sponsors are invited to an exclusive VIP Leadership Dinner, providing a prime networking opportunity with top industry leaders.

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TEDCO Invests in OmniSpeech

COLUMBIA, Md., (July 16, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 investment in OmniSpeech. This investment was made in two parts, with $300,000 coming from TEDCO’s Venture Funds and the remaining $200,000 coming from TEDCO’s Social Impact Funds.

“After decades of research and development, we are excited to expand our reach to improve more apps and devices with AI/ML-powered speech,” said Carol Espy-Wilson, founder and chief technology officer at OmniSpeech. “With TEDCO’s generous investments, we are excited to advance our innovative AI and machine learning technologies.”

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TEDCO Invests in Phycin, Inc.

Maryland-based company seeks to revolutionize green algae growth factors 

COLUMBIA, Md., (July 11, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 Pre-Seed Builder Fund investment in Phycin, Inc. TEDCO’s Pre-Seed Builder Fund is housed under TEDCO’s Social Impact Funds which were created to engage and invest in economically underserved founders and communities.

“At Phycin, we are focused on revolutionizing growth factor production, allowing researchers to continue their efforts with an efficient and cost-effective alternative,” said Jun Wang, CEO of Phycin, Inc. “Thanks to TEDCO’s investment, we can continue our research and development and hopefully offer more affordable and efficient solutions for various industries.”

Read More

 
Finalists selected for inaugural Bio Centrifuge Africa Competition – BHI’s Rich Bendis to be a Judge

As the first of its kind in South Africa, through a partnership between Eduvos and Task and supported by Wesgro, the inaugural Bio Centrifuge Africa competition will be selecting the winners on 17 July at the exclusive live pitching event in Cape Town.

The competition was launched this year to highlight South African talent in the expanding biotech sector and serve as a bridge between the country and the USA’s BioHealth Capital Region (BHCR). This groundbreaking event promises to propel visionary health-focused innovators and biomedicine students onto the global stage.

South Africa, through the Western Cape’s biotech hub, has forged a partnership with the BioHealth Capital Region in the US. As part of this collaboration, the winner of Bio Centrifuge Africa will have the opportunity to compete at the prestigious Crab Trap competition, scheduled for September 18, 2024, in Rockville, Maryland.

Read More

 

TEDCO Announces Graham Dodge as the New Vice President, Innovation Connectors

COLUMBIA, Md., (July 11, 2024) — TEDCO, Maryland’s economic engine for technology companies, announces the appointment of Graham Dodge as the vice president of the Innovation Connectors department. Dodge will be responsible for providing leadership and oversight to TEDCO’s Cultivate Maryland and Innovation Connectors.

The Innovation Connectors department, previously known as TEDCO’s Entrepreneur & Ecosystem Empowerment (E3) department, is responsible for driving strategic collaborations, supporting entrepreneurial innovation and defining strategies to leverage networks and resources for innovative success. The department houses influential programs intentionally created to support entrepreneurial growth, such as the Rural Business Innovation InitiativeUrban Business Innovation InitiativeNetwork AdvisorsPrelude Pitch and more.

Read More

 
Axios – How AI is driving the venture capital market

Artificial intelligence is keeping the venture capital ecosystem afloat. It accounted for more than 40% of new private U.S. “unicorns” in the first half this year, and over 60% of the increase in total venture-backed valuation, per PitchBook.

The big picture: There were 13 new U.S. AI unicorns — private companies that reached valuations of over $1 billion — between Jan. 1 and June 25 of this year.

  • Elon Musk’s xAI on its own added $24 billion in valuation, while all AI unicorn companies combined added $116 billion in aggregate value.
  • Overall U.S. unicorn value has grown by $162 billion so far this year.

Follow the money: Over the past few years, AI accounted for about 15%-17% of venture dollars invested in North America and Europe. That number increased to about 20% in 2023 and is rising even more in 2024, according to PitchBook senior emerging technology analyst Brendan Burke.

Click here to continue reading.

Read More

 

Emergent, J&J settle COVID vaccine supply deal dispute

July 8 (Reuters) – Emergent BioSolutions (EBS.N), opens new tab said on Monday Johnson & Johnson (JNJ.N), opens new tab has agreed to pay $50 million to settle claims related to a terminated manufacturing deal for the latter’s COVID-19 vaccine. Shares of the company rose about 2% in extended trading. In 2022 J&J informed Emergent of its decision to terminate the deal, citing breaches including failure to supply COVID-19 vaccine drug substance on the part of the contract manufacturer.

Emergent had said J&J breached the agreement by failing to buy the minimum quantity of COVID-19 vaccines made by the company.

Under the five-year agreement, opens new tab, signed in 2020, Emergent would provide contract manufacturing services to produce the COVID-19 vaccine drug substance for commercial manufacturing. It was valued at about $480 million for the first two years.

The U.S. health regulator had limited the use of the J&J vaccine in 2022 due to the risk of a rare blood clotting syndrome.

Read More

 
AMPEL BioSolutions: Lupus Treatment with Omega3-Rich Krill Oil Improves Disease Activity

CHARLOTTESVILLE, VA – July 15, 2024 – Today AMPEL BioSolutions, with collaborators Lupus Therapeutics and Aker Biomarine, revealed peer-reviewed results that supplementation with Omega3-rich Krill Oil improves disease activity of autoimmune Lupus patients. 

Omega3 lipids called polyunsaturated fatty acids (PUFAs) that are found in microscopic shrimp-like crustaceans called Krill from the waters around Antarctica are key to maintaining a low inflammatory state.  Some studies indicate that Krill contains Omega3 in an easily digested phospholipid form that may achieve more effective integration into cellular membranes compared with the triglyceride-rich form predominant in fish oil.  And the concentrated Superba Boost Krill Oil (AKBM-3031) was highly ranked by the evidence-based CoLTs (Combined Lupus Treatment Scoring) published approach for testing in the ORKIDS clinical trial.

Read More

 

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616th Edition, July 9, 2024

By BHI Weekly News Archives

BioHealth Capital Region Week 2024 Registration Now Open 

Join us this September for the BioHealth Capital Region Week 2024, a gathering that epitomizes the spirit of innovation in the biopharma industry. Hosted once again at US Pharmacopeia in Rockville, MD, from September 17th, 18th, and 19th, 2024, this event is made possible by the generous support of our sponsors, ensuring it remains free for all attendees. This year, we are featuring three cornerstone events: the 10th Annual BioHealth Capital Region Forum, the 9th Annual Crab Trap Competition, and the 7th Annual Investment Conference. Each event is tailored to foster unique opportunities for networking, learning, and investment, drawing together industry leaders, innovators, and investors from across the nation. We extend our heartfelt thanks to US Pharmacopeia for hosting us and to our sponsors whose contributions are vital in making these gatherings accessible to all. Click here to register and apply.

A Decade of Advancement and Achievement

This year marks the 10th anniversary of the BioHealth Capital Region Forum, and we are celebrating a decade of advancements that have positioned our region at the forefront of the biopharma industry. The Forum, spanning the first two days (September 17-18), will feature a lineup of speakers who are pioneers and thought leaders in the industry. Attendees will gain invaluable insights through keynote speeches, panel discussions, and sessions that delve into the latest innovations and trends shaping healthcare and biopharmaceuticals.

Crab Trap Competition: Where Innovation Meets Opportunity

The excitement peaks on September 18th with the 9th Annual Crab Trap Competition. This event showcases emerging companies as they pitch groundbreaking solutions to a panel of esteemed judges for a chance to win significant funding and support. It’s not just a competition; it’s a launchpad for the next generation of BioHealth innovations, providing startups with the visibility they need to attract investors and partners.

Connecting Innovators with Investors

The week concludes with the 7th Annual Investment Conference on September 19th, a must-attend for startups seeking investment and investors looking for the next big thing in BioHealth. This conference facilitates direct connections between up-and-coming companies and seasoned investors through curated meetings, fostering a dynamic environment for deal-making and partnership formation.

 

Read More

 
Elevate Your Startup: Apply to Compete in the 9th Annual Crab Trap Competition

Are you ready to showcase your company to some of the top minds in the industry? The 9th Annual Crab Trap competition, a highlight of the annual BioHealth Capital Region Week, is now accepting applications from emerging companies eager to demonstrate their groundbreaking solutions. Scheduled for September 18th at the US Pharmacopeia in Rockville, MD, this competition is an unmissable opportunity for startups looking to make a significant impact.

A Platform for Pioneers

The Crab Trap provides a unique platform for startups to present their innovations before a panel of esteemed judges and a live audience. This year’s competition promises exciting prizes, including cash and business services, to accelerate the winning entry’s growth and success.

Why Enter Crab Trap?

Participating in the Crab Trap competition offers numerous benefits:

  • Visibility: Gain exposure to a broad audience of industry professionals, investors, and potential partners.
  • Feedback: Receive valuable insights and feedback from leaders in the biohealth industry.
  • Prizes: Compete for a chance to win cash and services that can catalyze your company’s growth and development.

Apply Now

Read More

 

Cartesian Therapeutics Announces $130 Million Private Placement Equity Financing

GAITHERSBURG, Md., July 02, 2024 (GLOBE NEWSWIRE) — Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that it has entered into a securities purchase agreement for a private investment in public equity (“PIPE”) financing that is expected to result in gross proceeds of approximately $130.0 million to the Company, before deducting placement agent fees and other offering expenses. The PIPE financing is expected to close on or about July 3, 2024, subject to satisfaction of customary closing conditions.

The PIPE financing included participation from both new and existing investors, including HBM Healthcare Investments (Cayman) Ltd., Invus, Schooner Capital, Surveyor Capital (a Citadel company), Timothy A. Springer, Ph.D., a leading mutual fund manager, and other institutional investors.

Read More

 
Cartesian Therapeutics Announces Positive Topline Results from Phase 2b Trial of Descartes-08 in Patients with Myasthenia Gravis

GAITHERSBURG, Md., July 02, 2024 (GLOBE NEWSWIRE) — Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“Cartesian” or the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced positive topline results from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG).

Descartes-08, Cartesian’s lead product candidate, is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) directed against the B cell maturation antigen (BCMA). It is designed to be administered as an outpatient treatment without the need for lymphodepleting chemotherapy required to achieve activity with conventional CAR-T cell therapies. Descartes-08 was previously granted Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of MG.

Read More

 

TEDCO Announces Second Year of Maryland Makerspace Initiative Program Awardees

18 projects will receive funding to support their growth and development

COLUMBIA, Md., (June 27, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced the 2024 Maryland Makerspace Initiative Program (“Makerspace Program”) awardees. Funding will be awarded to 18 projects spanning across nine (9) counties and Baltimore City.

“TEDCO is committed to supporting the continued growth of innovation in Maryland. The Makerspace Program is just one tool that TEDCO has to promote this expansion,” said Terry Rauh, chief finance and operations officer at TEDCO. “And after witnessing the success and growth of last year’s awardees, we are hopeful that these awardees will continue the trend.”

Read More

 
Emergent BioSolutions Awarded $250+ Million in Contract Modifications to Supply U.S. Government with Four Critical Medical Countermeasure Products

GAITHERSBURG, Md., July 02, 2024 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced it has received more than $250 million in contract modifications from the Administration for Strategic Preparedness and Response (ASPR) at the United States Department of Health and Human Services (HHS), to deliver millions of doses of four medical countermeasures (MCMs). These contract modifications will help ensure continued supply/stockpiling of critical MCMs to address biological threats and emergencies against anthrax, smallpox and botulism.

Read More

 

Maryland Awards $500K to Early Charm Ventures for Biomanufacturing Incubator at Harford County Facility

BEL AIR, Md., (July 1, 2024) – Maryland Department of Commerce has awarded $500K to Baltimore-based Early Charm to develop a biomanufacturing incubator at a Harford County-owned facility near Aberdeen Proving Ground (APG). The funding from the state’s Build Our Future grant will be used to upgrade the CONVERGE Innovation Center, formerly known as the HEAT Center, located at the I-95/Aberdeen interchange.

Biomanufacturing is the use of biological processes to build new materials such as body armor made from spider silk, three times the strength of Kevlar. This technology has the potential to revolutionize manufacturing.

Read More

 
EDA: Biden-Harris Administration Announces Next Funding Round of $504 Million for 12 Tech Hubs Across America

WASHINGTON, DC — The Biden-Harris Administration, through the U.S. Department of Commerce’s Economic Development Administration (EDA), announced another funding round of approximately $504 million in implementation grants to 12 Tech Hubs to scale up the production of critical technologies, create jobs in innovative industries, strengthen U.S. economic competitiveness and national security, and accelerate the growth of industries of the future in regions across the United States.

The Tech Hubs Program is a flagship initiative of President Biden’s Administration to invest in and grow the economies in communities across the country, advancing America’s global leadership in critical technologies, and strengthening our national and economic security.

Read More

 

Sirnaomics Announces Interim Results for Successful Completion of the Second Cohort of Phase I Clinical Study of GalNAc-Based RNAi Therapeutic STP122G for Anticoagulant Therapeutics

HONG KONG and GERMANTOWN, Md. and SUZHOU, China, July 8, 2024 /PRNewswire/ — Sirnaomics Ltd. (the “Company“, together with its subsidiaries, the “Group” or “Sirnaomics“; stock code: 2257), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, today announced the interim results for successful completion of the second cohort of its Phase I clinical study of GalNAc-based RNAi therapeutic STP122G, targeting Factor XI as a novel form of anticoagulation agent.

Read More

 
Arlington’s Kerecis Expands Silicone Fish-Skin Combination Product Range with Shield Spiral, Offering Advanced Customizable Wound Care Solutions

ARLINGTON, Va.–()–Kerecis, the company pioneering the use of sustainably sourced fish skin and fatty acids in cellular therapy and tissue regeneration and protection, today announced the availability of Shield Spiral, an extension of the Kerecis Shield silicone fish-skin combination product range.

The patented, intact fish-skin graft and silicone combination, features perforated fenestration marks cut in a unique spiral pattern, allowing easy customization. The 30 mm graft can be reduced to as small as 15 mm by peeling away the 2 mm outer spiral sections and cutting to the desired size, providing unmatched flexibility and precision in treatment.

Read More

 

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615th Edition, July 2, 2024

By BHI Weekly News Archives

 

 

 

Shaping the Future of Health Computing in the BioHealth Capital Region: Insights from Dr. Bradley Maron on BioTalk 

Join us for an episode of BioTalk with Rich Bendis featuring Dr. Bradley Maron, Senior Associate Dean for Precision Medicine and Executive Co-Director of the University of Maryland-Institute for Health Computing at the University of Maryland School of Medicine. With his extensive background in cardiovascular research and precision medicine, Dr. Maron offers a wealth of knowledge and innovative perspectives.

In this episode, Dr. Maron shares his professional journey, discussing his various roles at the University of Maryland and what drew him to the region. He provides a comparative analysis of the ecosystems in Boston/Harvard and Maryland/University of Maryland, highlighting the unique attributes and opportunities within each.

Dr. Maron introduces the Institute for Health Computing (IHC), explaining its creation, mission, and strategic partnerships with the University System of Maryland and Montgomery County. He outlines the significance of data science in improving health and wellness, addressing its increasing role and challenges.

Listen Now Via Your Favorite Podcast Platforms:

Apple:https://apple.co/3VMHpt9 
Spotify: https://spoti.fi/3VEOTOI 
Amazon Music: https://amzn.to/4eIj14H 
TuneIn:https://bit.ly/4eJvgxU

Read More

 
BioHealth Capital Region Week 2024 Registration Now Open

Join us this September for the BioHealth Capital Region Week 2024, a gathering that epitomizes the spirit of innovation in the biopharma industry. Hosted once again at US Pharmacopeia in Rockville, MD, from September 17th, 18th, and 19th, 2024, this event is made possible by the generous support of our sponsors, ensuring it remains free for all attendees. This year, we are featuring three cornerstone events: the 10th Annual BioHealth Capital Region Forum, the 9th Annual Crab Trap Competition, and the 7th Annual Investment Conference. Each event is tailored to foster unique opportunities for networking, learning, and investment, drawing together industry leaders, innovators, and investors from across the nation. We extend our heartfelt thanks to US Pharmacopeia for hosting us and to our sponsors whose contributions are vital in making these gatherings accessible to all. Click here to register and apply.

A Decade of Advancement and Achievement

This year marks the 10th anniversary of the BioHealth Capital Region Forum, and we are celebrating a decade of advancements that have positioned our region at the forefront of the biopharma industry. The Forum, spanning the first two days (September 17-18), will feature a lineup of speakers who are pioneers and thought leaders in the industry. Attendees will gain invaluable insights through keynote speeches, panel discussions, and sessions that delve into the latest innovations and trends shaping healthcare and biopharmaceuticals.

Crab Trap Competition: Where Innovation Meets Opportunity

The excitement peaks on September 18th with the 9th Annual Crab Trap Competition. This event showcases emerging companies as they pitch groundbreaking solutions to a panel of esteemed judges for a chance to win significant funding and support. It’s not just a competition; it’s a launchpad for the next generation of BioHealth innovations, providing startups with the visibility they need to attract investors and partners.

Connecting Innovators with Investors

The week concludes with the 7th Annual Investment Conference on September 19th, a must-attend for startups seeking investment and investors looking for the next big thing in BioHealth. This conference facilitates direct connections between up-and-coming companies and seasoned investors through curated meetings, fostering a dynamic environment for deal-making and partnership formation.

Read More

 

From Tunisia to Maryland: FluoInk’s Journey at the SelectUSA Investment Summit

Professor Ramzi Maalej, CTO and Founder of FluoInk, recently traveled from Tunisia to Maryland to attend the SelectUSA Investment Summit. FluoInk is currently working on its innovative Bacti Cleaner technology, which adds antibacterial properties to paints. It is making strides in the eco-friendly and non-toxic product space with the development of this product.

BioHealth Innovation Inc. (BHI) is collaborating with FluoInk, along with partners from The Tunisian Health Center for University Research Excellence and Sustainability (CURES) and FHI 360, to help grow their business. While in Maryland, Professor Maalej connected with key figures in the BioHealth Capital Region, including Brian Castleberry, Senior Regional Manager – Middle East, Africa, and UK at the Maryland Department of Commerce, and Brian Darmody, AURP Chief Strategy Officer.

“Visiting Maryland and participating in the SelectUSA Investment Summit was an incredible experience. The networking opportunities and the collaborative environment, facilitated by BHI and FHI 360, were beyond my expectations,” said Professor Ramzi Maalej, CTO and Founder of FluoInk. “This summit has opened new doors for transforming our academic research into impactful commercial products.”

Read More

 
ARPA-H announces small business funding opportunity

Agency seeks proposals for innovative research and development from small businesses 

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced new funding opportunities through the Small Business Innovation Research (SBIR)/ Small Business Technology Transfer (STTR) program. 

The ARPA-H SBIR/STTR solicitation seeks proposals from small businesses that aim to rapidly achieve better health outcomes across patient populations, communities, disease, and health conditions.

Read More

 

TEDCO Announces Second Year of Maryland Makerspace Initiative Program Awardees

18 projects will receive funding to support their growth and development

COLUMBIA, Md., (June 27, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced the 2024 Maryland Makerspace Initiative Program (“Makerspace Program”) awardees. Funding will be awarded to 18 projects spanning across nine (9) counties and Baltimore City.

“TEDCO is committed to supporting the continued growth of innovation in Maryland. The Makerspace Program is just one tool that TEDCO has to promote this expansion,” said Terry Rauh, chief finance and operations officer at TEDCO. “And after witnessing the success and growth of last year’s awardees, we are hopeful that these awardees will continue the trend.”

Read More

 
TJP: 2023 Crab Trap Finalist EyeControl creates revolutionary medical technology

EyeControl improves clinical outcomes, prevent cognitive decline, and enhance the patient and family experience.“We are honoured to be able to support every patient – but especially our soldiers.”

When Yoav Tzivoni, a combat soldier seriously wounded in the northern Gaza Strip, awoke after six months in the intensive care unit of the Samson Assuta Ashdod University Hospital, he shockingly asked the nurse for his favorite heavy metal music.

“I was shaking from excitement when the nurse texted and said Yoav is asking for his music!” recounts Michal Finkelstein, product specialist, and speech and language pathologist by training, in charge of customer relations and success at the Israeli company EyeControl.

“What? Is he awake?” Finkelstein wondered, saying that she was “shaking from excitement.”

Tzivoni and his fellow wounded ICU soldiers are benefiting from a recently discovered additional and potentially internationally game-changing use of EyeControl, a wearable device that enables patients – including those on ventilators – to communicate with medical staff and family members via eye gestures and a bone conduction headset, to hear the recorded messages of loved ones – and to listen to one’s favorite music.

EyeControl helps improve clinical outcomes, prevent cognitive decline, and enhance the patient and family experience. It is currently being tested in prestigious university hospitals in and out of Israel to see if it reduces delirium in ICU patients.

Read More

 

Gain Therapeutics Appoints Gene Mack as Interim CEO

BETHESDA, Md., June 27, 2024 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announces that Matthias Alder has departed the Company in order to pursue other opportunities. Upon Mr. Alder’s departure, the Company appointed Gene Mack, the Company’s current Chief Financial Officer, as interim Chief Executive Officer, effective June 25, 2024. Mr. Mack will retain his role as Chief Financial Officer. Khalid Islam, Ph.D., founder and Chairman of the Company’s Board of Directors, will bolster management as Executive Chairman until a permanent CEO is appointed.

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Fierce Healthcare: AWS doles out part of $10M grant to major children’s hospitals to advance pediatric cancer treatment

WASHINGTON, D.C. — Amazon Web Services committed $10 million to fund pediatric rare disease research, including cancer, on Wednesday at its annual summit in the nation’s capital.

The tranche of cash is first being allocated through three, $1 million grants to Children’s National Hospital in Washington, D.C.; Nationwide Children’s Hospital in Columbus, Ohio; and the Children’s Brain Tumor Network, located at the Children’s Hospital Of Philadelphia. 

AWS says the unrestricted cash grant will allow the children’s cancer centers, which are already using AWS software, to continue innovation in accelerating pediatric research, improving well-being for children and empowering the professional pediatric workforce and caregivers of children. 

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CraniUS™ Awarded Competitive $1 Million Grant from the State of Maryland’s Build Our Future Innovation Infrastructure Program

BALTIMORE–()–CraniUS, an R&D company focused on groundbreaking diagnostics and treatments for patients with chronic brain disease, has been awarded a competitive $1 million grant from the State of Maryland as part of Governor Wes Moore’s Build Our Future Innovation Infrastructure Pilot Program. This funding milestone – the first ever granted by the state program – will help CraniUS expand its research capabilities, accelerate product development into human studies, and enhance its contributions to Maryland’s innovation ecosystem.

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Welldoc Announces Collaboration to Support Cardiometabolic Health by Integrating AI-Driven Digital Coaching with Instacart’s Innovative Technology Platform to Increase Access to Nutritious Groceries

COLUMBIA, Md., June 25, 2024 — Welldoc®, a leading digital health company specializing in AI-driven cardiometabolic health, today announced a collaboration with Instacart, the leading grocery technology company in North America, to transform healthcare delivery for health plans and members by bridging the gap between nutrition and health. Through enhanced access to quality care and nutritious food, Welldoc aims to improve health outcomes and reduce overall costs of care for individuals managing cardiometabolic conditions.

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614th Edition, June 25, 2024

By BHI Weekly News Archives

Transforming Healthcare: The FDA’s Dr. Michelle Tarver on New Initiatives and the Future of Medical Devices on the BioTalk Podcast 

Join us for a compelling episode of BioTalk with Rich Bendis as we welcome Dr. Michelle E. Tarver, Deputy Center Director and Chief Transformation Officer at the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA). With a distinguished background as a board-certified ophthalmologist and epidemiologist, Dr. Tarver is at the forefront of transforming the evaluation and inclusion of medical devices in underserved and underrepresented populations.

In this episode, Dr. Tarver introduces the FDA and the CDRH Division, explaining the definition of a medical device by FDA standards. She discusses the creation of the Chief Transformation Officer role within the FDA, highlighting its importance and the strategic vision behind it.

Listen now via your favorite podcast platforms.

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TuneIn: https://bit.ly/4czGVO0

We explore the critical importance of diversity, equity, and inclusion (DEI) in evaluating medical devices, and how these efforts are essential for ensuring equitable healthcare for all. Dr. Tarver introduces the innovative “Home as a Health Care Hub” initiative by the FDA/CDRH, explaining its potential to revolutionize healthcare delivery.

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Emergent BioSolutions Announces Sale of Baltimore-Camden Manufacturing Site to Bora Pharmaceuticals for $30 Million

GAITHERSBURG, Md., June 20, 2024 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced that it has entered into a definitive agreement to sell its drug product facility in Baltimore-Camden to an affiliate of Bora Pharmaceuticals Co., Ltd. (“Bora”, TWSE: 6472), a leading international pharmaceutical services company, for a total value of approximately $30 million. The Camden site, which is part of Emergent’s Contract Development and Manufacturing Organization (CDMO), has clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services. Alongside the facility, approximately 350 current Emergent employees are expected to join Bora as part of the transaction.

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Ascentage Pharma Announces Closing of US$75 Million Equity Investment by Takeda

ROCKVILLE, Md. and SUZHOU, China, June 20, 2024 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that the agreed equity investment by Takeda has been closed on June 20, 2024, with all proceeds already received. Pursuant to the terms of the Agreement, Ascentage Pharma has allotted and issued an aggregate of 24,307,322 subscription shares to Takeda International at the share purchase price of HK$24.09850 (equivalent to approximately US$3.08549).

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REGENXBIO Announces Expansion of AFFINITY DUCHENNE® Trial to Include a New Cohort of Younger Patients

WASHINGTON, June 13, 2024 /PRNewswire/ — Vanda Pharmaceuticals Inc. (“Vanda” or the “Company”) (Nasdaq: VNDA) today confirmed that it has received a revised unsolicited proposal from Future Pak, LLC (“FP”) to acquire Vanda for $8.50-$9.00 per share in cash plus certain Contingent Value Rights.

Consistent with its fiduciary duties, and in consultation with its financial and legal advisors, Vanda’s Board will carefully review and evaluate the revised, non-binding proposal to determine the course of action that it believes is in the best interests of the Company and its shareholders.

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RichmondBizSense: Life sciences startup support program looks to boost biohealth industry in Richmond

Ianne Salvosa June 18, 2024 – Efforts are afoot to make Richmond more of a player in the biohealth industry.

Downtown-based Activation Capital is launching the Frontier BioHealth program to provide training and mentorship for up to 10 startups from August to November to groom life sciences companies in the area for the long term.

Activation Capital Vice President of Entrepreneurship Jim Pannucci said the program is a nod to the group’s original mission to help the region and the VA Bio+Tech Park be a hub of biotechnology. Activation Capital operates the park, while supporting entrepreneurship and startups in the region through various programs.

The Bio+Tech Park was established about three decades ago to turn Richmond into a center of biotechnology and now about 70 companies and research facilities operate in the area, with interests ranging from smoke-free tobacco alternatives to organ donation.

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Unlock Your Innovation Potential with BioHealth Innovation’s Grant Mapping Services

Navigating the complex landscape of non-dilutive funding can be daunting for many innovators and researchers. Identifying suitable grants that align with specific project goals is often challenging, requiring a deep understanding of the funding landscape and specific program criteria.

We recognize these challenges at BioHealth Innovation (BHI) and are committed to supporting your journey. Our comprehensive grant mapping services are designed to pinpoint the most relevant funding opportunities tailored to your unique needs. With our expert guidance, you can confidently navigate the intricate world of grants, ensuring that your projects receive the support they deserve.

In addition to our grant mapping services, BHI offers dedicated SBIR/STTR grant writing assistance. Our team of seasoned professionals will work closely with you to craft compelling grant proposals that stand out to funding agencies. We understand the nuances and expectations of these programs, which significantly enhances your chances of success.

Partner with BHI to leverage our expertise and maximize your chances of securing the right non-dilutive funding for your innovative projects. With our support, you can focus on what you do best—innovating and pushing the boundaries of biohealth and life sciences

Let BHI be your trusted partner in navigating the funding landscape and unlocking the full potential of your groundbreaking work. If you’re seeking assistance, don’t hesitate to reach out to Jon NelsonatJNelson@BioHealthInnovation.org.

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613th Edition, June 18, 2024

By BHI Weekly News Archives

 

Leading the Charge in Tech-Based Economic Development: A Conversation with Dan Berglund of SSTI on BioTalk 

Join us for an enlightening episode of BioTalk with Rich Bendis as we welcome Dan Berglund, President and CEO of SSTI. With nearly four decades of experience in tech-based economic development (TBED), Dan has been a pivotal figure in shaping the landscape of innovation and entrepreneurship across the nation.

In this episode, Dan shares the history and evolution of Technology Based Economic Development, discussing key initiatives in states like Ohio and Pennsylvania, and at the federal level. He highlights the importance of partnerships, detailing a compendium of state and federal cooperative technology programs that have driven progress in the field.

We explore the early years of SSTI, looking into its creation, mission, and initial goals, and how it has grown to support a nationwide network dedicated to fostering tech-based economies. Dan discusses the evolution and growth of state TBED programs, and the changing role of the federal government in supporting these initiatives through agencies like STCS, OSTP, Commerce, NIST, and EDA.

Apple: https://apple.co/3RwdqEJ
Spotify: https://spoti.fi/3RrmIlh
Amazon Music: https://amzn.to/3vpZDHI
TuneIn: https://amzn.to/3xvGFjX

Dan also emphasizes the importance of private/public TBED partnerships, sharing insights into how these collaborations have bolstered economic growth and innovation. As he prepares to step down from his role after 28 years,and assume a part time role,  Dan discusses the recruitment of a new CEO and reflects on SSTI’s achievements, his legacy, and his vision for the organization’s future.

Additionally, Dan talks about Rich Bendis’s role as an original founding board member of SSTI, and his significant help in the early development of the organization. He also highlights the presence of several SSTI members in the BioHealth Capital Region.

 

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Unlock Your Innovation Potential with BioHealth Innovation’s Grant Mapping Services

Navigating the complex landscape of non-dilutive funding can be daunting for many innovators and researchers. Identifying suitable grants that align with specific project goals is often challenging, requiring a deep understanding of the funding landscape and specific program criteria.

We recognize these challenges at BioHealth Innovation (BHI) and are committed to supporting your journey. Our comprehensive grant mapping services are designed to pinpoint the most relevant funding opportunities tailored to your unique needs. With our expert guidance, you can confidently navigate the intricate world of grants, ensuring that your projects receive the support they deserve.

In addition to our grant mapping services, BHI offers dedicated SBIR/STTR grant writing assistance. Our team of seasoned professionals will work closely with you to craft compelling grant proposals that stand out to funding agencies. We understand the nuances and expectations of these programs, which significantly enhances your chances of success.

Partner with BHI to leverage our expertise and maximize your chances of securing the right non-dilutive funding for your innovative projects. With our support, you can focus on what you do best—innovating and pushing the boundaries of biohealth and life sciences

Let BHI be your trusted partner in navigating the funding landscape and unlocking the full potential of your groundbreaking work. If you’re seeking assistance, don’t hesitate to reach out toJon NelsonatJNelson@BioHealthInnovation.org.

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Seraxis Wins Maryland Stem Cell Research Fund Grant to Accelerate Development of Allogenetically Compatible Pancreatic Islet Replacement Therapy for Functional Cure of T1D

GERMANTOWN, MD / ACCESSWIRE / June 14, 2024 / Seraxis, Inc., a regenerative medicine company developing pancreatic islet replacement therapies to transform the lives of patients with Type 1 and insulin-requiring Type 2 diabetes, has been notified that the company is the awardee of a $400,000 Commercialization Program grant from the Maryland Stem Cell Research Fund (MSCRF) that aims to foster Maryland research to enhance and propel stem cell treatments. Seraxis will use the MSCRF grant to accelerate the validation and manufacturing of Seraxis’ genetically modified pancreatic cell line (SR-03) that is designed to be a universal allogenic transplant that will not require lifelong anti-rejection immune suppression.

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Vanda Pharmaceuticals Confirms Receipt of Revised Unsolicited Takeover Proposal from Future Pak

WASHINGTON, June 13, 2024 /PRNewswire/ — Vanda Pharmaceuticals Inc. (“Vanda” or the “Company”) (Nasdaq: VNDA) today confirmed that it has received a revised unsolicited proposal from Future Pak, LLC (“FP”) to acquire Vanda for $8.50-$9.00 per share in cash plus certain Contingent Value Rights.

Consistent with its fiduciary duties, and in consultation with its financial and legal advisors, Vanda’s Board will carefully review and evaluate the revised, non-binding proposal to determine the course of action that it believes is in the best interests of the Company and its shareholders.

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TEDCO’s Maryland Innovation Initiative Announces Kulshreshtha as the New Executive Director

COLUMBIA, Md., (June 13, 2024) — The Maryland Innovation Initiative (MII) Board of Directors announces the appointment of Abishek Kulshreshtha as the executive director of TEDCO’s MII program. In this position, Kulshreshtha will oversee all MII activities starting July 1, 2024.

As an independent unit within TEDCO, the Maryland Technology Development Corporation, MII was created to promote the commercialization of research conducted in five of Maryland’s academic research institutions (Johns Hopkins University; Morgan State University; University of Maryland, Baltimore; University of Maryland, Baltimore County; and University of Maryland, College Park) while leveraging each institution’s strengths. This collaborative program has supported more than 170 startup companies, created 370 jobs and procured more than $737 million in follow-on funding since its inception nearly 12 years ago.

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Northwest Biotherapeutics Announces Exclusive In-License of Portfolio of Dendritic Cell Technology and Intellectual Property

BETHESDA, Md., June 17, 2024 /PRNewswire/ — Northwest Biotherapeutics, Inc. (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP).  The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies.  The license is the culmination of more than 2 years of discussions and negotiations.

The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them.  The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.

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Novavax Submits Application to U.S. FDA for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine

GAITHERSBURG, Md., June 14, 2024/PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that it has submitted an amendment to its Emergency Use Authorization to the U.S. Food and Drug Administration (FDA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. The submission is in line with guidance from the U.S. FDA, European Medicines Agency (EMA) and the World Health Organization (WHO) to target the JN.1 lineage this fall.1-3 

Novavax’s JN.1 vaccine has demonstrated broad cross-neutralizing antibodies against multiple variant strains, including KP.2 and KP.3, indicating the potential to protect against forward drift variants. As discussed at the recent FDA Vaccines and Related Biological Products Advisory Committee meeting, there is a public health benefit to target JN.1, the parent strain of the most common currently circulating variants.

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Ascentage Pharma Signs Option Agreement with Takeda to Enter into Exclusive Global License for Olverembatinib, a Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI)

ROCKVILLE, Md. and SUZHOU, China, June 14, 2024 /PRNewswire/ — Ascentage Pharma (6855 HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today the signing of an option agreement with Takeda to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class third-generation BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukemia (CML) and other hematological cancers. If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of among others, mainland China, Hong Kong, Macau, Taiwan, China.

Despite the impact TKIs have had in the treatment of patients with CML, there remains a significant unmet need for patients whose disease is resistant to these therapies or who develop hard-to-treat mutations following these treatments.

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REGENXBIO Announces Leadership Transition

ROCKVILLE, Md., June 12, 2024 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced that Curran Simpson, Chief Operating Officer, has been appointed as President, Chief Executive Officer and a member of the Board of Directors, effective July 1, 2024. Co-Founder Kenneth T. Mills will step down as President and Chief Executive Officer following 15 years of leadership at the Company, and he is taking on an expanded role on the Board as Chairman. In connection with these changes, Board member Daniel Tassé has been appointed as REGENXBIO’s Lead Independent Director, a role previously held by Jerry Karabelas, Ph.D. Dr. Karabelas and Co-Founder Allan Fox, who has served as Chairman since 2020, will remain on the Board.

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TEDCO Invests in Kubanda Cryotherapy

Biotechnology company innovates treatment for pets with lumps, bumps and cancer

COLUMBIA, Md., (June 11, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 Pre-Seed Builder Fund investment in Kubanda Cryotherapy. The Pre-Seed Builder Fund is housed under TEDCO’s Social Impact Funds, which were created to engage and invest in economically underserved founders and communities.

“Most pet tumors go untreated, and existing treatment options are inaccessible due to high costs and slow healing times,” said Bailey Surtees, CEO of Kubanda Cryotherapy. “We saw this gap in care and built an alternative, non-surgical solution, which offers less down time and better healing outcomes for pets. With TEDCO’s support, we can continue our mission of breaking down barriers to high-quality care.”

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KeViRx, Inc. Awarded $1.99 Million to Advance Small Molecule Technology for Acute Lung Injury

CHARLOTTESVILLE, VA / ACCESSWIRE / June 11, 2024 / KeViRx, Inc., an innovative, early-stage pharmaceutical company, announced today the receipt of $1.99 million in grant funding from the U.S. Department of Defense’s Peer Reviewed Medical Research Program. This grant funding will allow KeViRx to advance its first-in-class small molecule platform technology, KVX-053, toward IND for pulmonary microvascular leakage and inflammation during acute lung injury (ALI). In the U.S., ALI affects 200,000 patients every year and can result from viral infection, sepsis, pneumonia or inhalation of chemical toxins. The most severe form of ALI is referred to as acute respiratory distress syndrome or ARDS.

“There are very limited treatment options for patients with ALI and 40% will die of ARDS,” KeViRx Co-founder John S. Lazo said. “KVX-053 is a host-directed, insult-agnostic small molecule that targets the central pathways that are dysfunctional in ARDS. If we are successful, KVX-053 would be transformative for this disease.”

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612th Edition, June 11, 2024

By BHI Weekly News Archives

Linshom Medical Picked by TechConnect as Finalist in the Medical Threat Challenge 

BALTIMORE, MD, US, June 10, 2024 /EINPresswire.com/ — Linshom Medical, a start-up medical device company was selected to present at the TechConnect World Innovation Conference on June 18, 2024 in Washington DC. After a competitive evaluation of over 100 applications, Linshom Medical was chosen as 1 of 13 companies to present at the Medical Threat Reduction Challenge, to an expert panel of judges, including federal funders, Medical CBRN Defense Consortium (MCDC) representatives, investors, and private corporations for a chance to earn a portion of $50,000 in non-dilutive prize money.

Linshom Medical is first to deliver an operating room quality respiratory profile to the patient bedside for continuous, predictive respiratory monitoring (CPRM). Recent data shows that the wearable, FDA cleared sensor provides health care providers 15 minutes of advance notice of respiratory decline compared to current standard of care. Clinical care team intervention during this early notice window is typically simple and inexpensive vs. the costly later alternatives when patients experience respiratory decline and are in trouble. These include rapid response activation, rescue events (codes), ICU transfers and potentially death.

 

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HyperSpectral Announces $8.5M Series A Funding to Accelerate Deployment of Spectral Artificial Intelligence Software

Company Focused on Bringing Industry-Leading Technology to Market in Food Safety and MedTech Industries 

ALEXANDRIA, Va., June 5, 2024 /PRNewswire/ — HyperSpectral, the world’s first AI-powered spectral intelligence company with hardware-agnostic solutions for particle detection, emerged from stealth today with $8.5 million in a Series A funding round. HyperSpectral’s Series A round was co-led by RRE Ventures and  Kibo Ventures with participation from Correlation Ventures, and GC&H Investments. The funds will allow the company to ramp up development of the technology, hire key talent, and create wider AI datasets through lab partnerships and testing.

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I-Mab Announces Collaboration with Bristol Myers Squibb to Evaluate Givastomig in a Combination Study for Newly Diagnosed Gastric and Esophageal Cancers

ROCKVILLE, Md., June 5, 2024 /PRNewswire/ — I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer, today announced that it has entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY). The collaboration will evaluate the combination of givastomig, an investigational Claudin 18.2 x 4-1BB bispecific antibody jointly developed by I-Mab and ABL Bio (KOSDAQ: 298380), with Bristol Myers Squibb’s immune checkpoint inhibitor, nivolumab, and chemotherapy (FOLFOX or CAPOX), as a potential first-line treatment for patients with advanced Claudin 18.2-positive gastric and esophageal cancers.

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Innovators Wanted: Secure Federal Funding with BioHealth Innovation’s Help

Did you know? Each year, the federal government dedicates around $3.6 billion towards SBIR and STTR programs, resulting in awards to over 5,000 innovative projects!

The next deadline for NIH SBIR/STTR proposals is September 5th. As an innovation intermediary, BioHealth Innovation (BHI) is here to help you secure federal funding.

If you’re seeking assistance, don’t hesitate to reach out to Jon Nelson at JNelson@BioHealthInnovation.org. Let’s innovate together!

Read More

 

IGC Pharma Publishes Study in European Society of Medicine Investigating the Impact of CYP2C9 Genetic Polymorphism on Pharmacokinetics of Delta 9 Tetrahydrocannabinol

— Study Deepens Understanding of Treatments for Alzheimer’s Patients, Enabling More Effective Treatments —

POTOMAC, Md.–(June  10, 2024)–IGC Pharma, Inc. (NYSE American: IGC) (“IGC” or the “Company”), today announced the publication of a significant research article in the European Society of Medicine Journal. The study investigates the effects of CYP2C9 polymorphisms on the pharmacokinetics (“PK”) of delta-9-tetrahydrocannabinol (“THC”) and its active metabolite in Alzheimer’s disease (“AD”) patients.

The publication is titled “A study on CYP2C9 polymorphism in Puerto Rican Alzheimer’s Patients and its role in the Pharmacokinetics of ∆-9-tetrahydrocannabinol” and is available at https://esmed.org/MRA/mra/article/view/5380.

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Barinthus Bio’s VTP-300 Trials Demonstrate Ability to Achieve Undetectable HBsAg levels and Statistical Significance in Lowering HBsAg Levels in People with Chronic Hepatitis B

OXFORD, United Kingdom, June 06, 2024 (GLOBE NEWSWIRE) — Barinthus Biotherapeutics plc (NASDAQ: BRNS), a biopharmaceutical company developing novel T cell immunotherapeutic candidates, today announced the presentation of updated data from two clinical trials in people with chronic hepatitis B (CHB) at the European Association for the Study of the Liver (EASL) Congress 2024. The presentations include updated interim data from the Phase 2b clinical trial (HBV003), as well as new interim EOT data from the Phase 2a clinical trial (IM-PROVE II, AB-729-202) in partnership with Arbutus Biopharma (NASDAQ: ABUS), both in people with CHB receiving ongoing SoC NUC therapy.

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REPROCELL USA Receives Funding from Maryland Stem Cell Research Fund (MSCRF)

REPROCELL USA is proud to announce that it has received funding from MSCRF for both proposals it has submitted for the MSCRF’s January 2024 grant cycle. These two grants will help us produce Master Cell Banks (MCB) for cell therapy and enhance our capacity to produce therapeutic cell products.

BELTSVILLE, Md., June 5, 2024 /PRNewswire/ — REPROCELL is a leader in producing clinically relevant human induced pluripotent stem cells (hiPSCs). These hiPSCs are generated from healthy donors that have been screened for eligibility using the questionnaire established by the US Food & Drug Administration (FDA). Further viral testing is performed to satisfy the requirements of FDA, European Medicines Agency (EMA) and Pharmaceutical and Medical Devices Agency (PMDA) of Japan. The first grant titled: “Generation of human iPSC and MSC MCBs and derivative products in an enclosed GMP system” will help REPROCELL offer two GMP grade cell lines in the next 8 to 12 months for commercialization. These products will be tested for quality and ready for off-the-shelf distribution and further differentiation internally, by other companies in Maryland and the rest of the world. This grant is funded by MSCRF under their commercialization grant that provides funding for commercializing the products.

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US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk

PHILADELPHIA, June 07, 2024–(BUSINESS WIRE)–GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. In the US, the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making.

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611th Edition, June 4, 2024

By BHI Weekly News Archives

Advancing Biotech: Insights from Michael J. Tarlov, Chief of the Biomolecular Measurement Division at NIST on BioTalk 

Join us for an enlightening episode of BioTalk with Rich Bendis, featuring Michael J. Tarlov, Chief of the Biomolecular Measurement Division at the Material Measurement Laboratory, NIST. With a distinguished career in analytical chemistry and extensive experience in biochemical sensing and bioprocess measurements, Michael leads critical initiatives to advance biotechnology and healthcare.

In this episode, we delve into the pivotal role of NIST as a non-regulatory agency within the Department of Commerce, highlighting its profound impact on measurement science, gene therapy, gene editing, synthetic biology, and regenerative medicine. Michael shares insights into NIST’s collaborations, including local companies like MedImmune/AstraZeneca and Novavax, and the importance of partnerships with academic institutions like the University of Maryland in driving local biotech advancements.

Listen now via:

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Innovators Wanted: Secure Federal Funding with BioHealth Innovation’s Help

Did you know? Each year, the federal government dedicates around $3.6 billion towards SBIR and STTR programs, resulting in awards to over 5,000 innovative projects!

The next deadline for NIH SBIR/STTR proposals is September 5th. As an innovation intermediary, BioHealth Innovation (BHI) is here to help you secure federal funding.

If you’re seeking assistance, don’t hesitate to reach out to Jon Nelson at JNelson@BioHealthInnovation.org. Let’s innovate together!

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BioHealth Innovation Inc. Celebrates miRecule’s Triumph at INVEST Pitch Perfect

At BioHealth Innovation Inc. (BHI), we are happy to celebrate the achievements of our partner company, miRecule, which has recently been named a winner at the INVEST Pitch Perfect competition. miRecule’s innovative approach to RNA therapies represents a significant advance in the treatment of cancer and muscular dystrophy. By leveraging genomic data to design highly specific therapeutics, miRecule stands at the forefront of personalized medicine, underscoring our commitment to supporting ground-breaking healthcare solutions.

This recognition is not just a win for miRecule; it’s a testament to the power of strategic partnerships and the impact of innovative biotechnological advances in addressing complex health challenges. BHI is proud to be associated with pioneers like miRecule, as we continue to foster a thriving ecosystem that brings revolutionary treatments from the lab to the patients who need them most.

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Linshom Medical Receives $100K MIPS award and Launches Clinical Study with Univ. of Maryland School of Medicine Faculty

BALTIMORE, MD, US, May 29, 2024 /EINPresswire.com/ — Linshom Medical, a Maryland-based startup developing a wearable respiratory monitoring system, announced today that it has been awarded a $100,000 grant from the Maryland Industrial Partnerships (MIPS) program to support a clinical study of its respiratory monitoring device.

The study, “Advanced Prediction of Respiratory Depression Episodes with Linshom Continuous Predictive Respiratory Monitoring (CPRM),” will evaluate the Linshom Medical device’s ability for early detection of patient respiratory decline in the Post Anesthesia Care Unit. Dr. Samuel M. Galvagno, Executive Vice Chair of Anesthesiology and Interim Chair of the Department of Anesthesiology, will lead this effort for UMSOM as the principal investigator.

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Precision for Medicine Acquires Algorics, Enhancing Clinical Technologies and APAC Presence

The acquisition adds two proprietary clinical technologies to its portfolio and enhances Precision’s global capabilities in clinical data management, biostatistics and programming.

BETHESDA, Maryland, May 29 – Precision for Medicine, a global leader in biomarker-driven clinical research and development supporting life sciences companies, today announced the acquisition of Algorics, one of the fastest-growing clinical technologies and biometrics service providers to the biopharma industry. The addition of Algorics brings two innovative clinical technologies and further bolsters Precision for Medicine’s reach in the Asia-Pacific region. The acquisition also enhances Precision’s global capabilities in clinical data management, biostatistics, and programming.

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Frederick’s Theradaptive Secures $1M in Funding from Maryland Stem Cell Research Fund for Human Clinical Trials

FREDERICK, Md., May 22, 2024 /PRNewswire/ — Theradaptive, Inc., a regenerative medicine company developing targeted therapeutics, announced today it has been awarded funding from the Maryland Stem Cell Research Fund (MSCRF) to support human clinical trials for its lead product, OsteoAdapt SP.  OsteoAdapt SP is currently in Phase I/II clinical studies for transforaminal lumbar interbody spinal fusion (TLIF) to treat degenerative disc disease, spondylolisthesis, and retrolisthesis.

Theradaptive was granted an Investigational Device Exemption (IDE) in January 2024 by the U.S. Food and Drug Administration (FDA) to begin its human clinical trial. This $1 million award from the MSCRF Clinical Program will enable Theradaptive to expand its OASIS human clinical study to sites in Maryland. More details can be found at ClinicalTrials.gov: identifier NCT06154005. Theradaptive also holds three Breakthrough Medical Device designations for various spine indications including TLIF, ALIF, and PLF.

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Alda Mizaku named chief data and artificial intelligence officer at Children’s National Hospital

Washington, D.C., June 03, 2024 (GLOBE NEWSWIRE) — Children’s National Hospital is pleased to welcome Alda Mizaku in a newly established role of vice president and chief data and artificial intelligence officer (CDAIO). In this role, Mizaku will lead the execution of enterprise data, analytics and artificial intelligence (AI) strategy at Children’s National.

Mizaku has a track record of leading initiatives with measurable organizational value, from reducing unnecessary length of stay to enhancing operational efficiency and patient outcomes. Prior to joining Children’s National, Mizaku spent 11 years working for Mercy Health System in St. Louis, where she served in various roles, including executive director of Data Engineering and Analytics, and vice president of Analytics Product Management.

 

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AMPEL BioSolutions Building Evidence for Prognostic Potential of Lupus Molecular Subtyping Test

NEW YORK – AMPEL BioSolutions is recruiting individuals with systemic lupus erythematosus (SLE) into an observational study of its blood-based prognostic gene expression assay LuGene to demonstrate a correlation between test results and standard clinical evaluations.

In addition, the company has been conducting a study to see whether different lupus subtypes as defined by its test correlate with therapeutic response.

These studies follow another one published in October in the journal Genome Medicine that showed evidence for eight transcriptionally defined SLE endotypes, or subgroups, and demonstrated LuGENE’s ability to predict patients at risk for episodes of worsening symptoms called flares with high sensitivity and specificity.

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ATCC Announces Award from NIAID to Provide Antiviral Screening Assays Relevant to Human Diseases

MANASSAS, Va.–()–ATCC, the world’s premier biological materials management and standards organization, today announced that it has been awarded a task order with a ceiling value of $15.5 million, inclusive of base and options, by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Under this task order 75N93019D00002-75N93024F00001, ATCC will develop well-characterized challenge material (WCCM) for the In Vitro Assessment for Antimicrobial Activity (IVAAA) program. This program aims to evaluate candidate countermeasures against microbial pathogens and vectors, including those derived from clinical specimens. The assessments are conducted in vitro and focus on antiviral screening assays for biosafety level (BSL)-3/4 viruses relevant to human diseases, as well as other rapidly emerging viruses that employ similar assay methodologies.

Due to the rise in countermeasures requiring the use of well-characterized viral stocks for animal studies and human clinical trials, researchers are examining the potential impact of cell substrates on the genetic stability and quality of progeny virus following serial propagation. In mammalian cells, serially propagating viruses can lead to rapid increases in genetic variants and instability, which have been shown to impact the interpretation of data from animal studies as well as from clinical trials. Ensuring the genomic homogeneity of WCCM, as well as improving the production capacity of WCCM used in drug screening studies, is essential for therapeutic drug development.

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New TEDCO Study Outlines Steps for Developing Maryland’s Cybersecurity Workforce

COLUMBIA, Md., (May 29, 2024) — TEDCO, Maryland’s economic engine for technology companies, unveiled the recently completed “Cybersecurity Workforce Analysis and Study” (“Study”). The Study was commissioned by TEDCO to better understand the current status of Maryland’s cybersecurity workforce pipeline. This knowledge will be used to guide the Cyber Maryland Program (“Program”) and its 18-member board of directors as they develop a statewide cybersecurity workforce development strategic plan.

“The Study confirms what businesses and government agencies in Maryland already know: demand for skilled cybersecurity professionals—who protect our communities from criminals threatening our way of life—is incredibly nuanced. Thankfully, there is support and momentum amongst key stakeholders to bridge our talent gap,” said Roger Austin, chair of the Cyber Maryland board of directors. “My fellow board members and I are committed to address this critical need by developing innovative solutions to overcome our cyber skills talent gaps and provide good, paying jobs for our state’s residents.”

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