BioHealth Innovation Weekly for October 22, 2024

Trouble Viewing This Email: Click Here

October 22, 2024

Revolutionizing Global Drug Manufacturing with Dr. Frank Gupton of Phlow and Medicines for All on BioTalk

In this episode of BioTalk, Rich Bendis speaks with Dr. Frank Gupton, Co-Founder of Phlow and CEO of the Medicines for All Institute, about his pioneering efforts to improve pharmaceutical manufacturing and global access to essential medications.

Dr. Gupton shares how Phlow is addressing vulnerabilities in the U.S. pharmaceutical supply chain by producing critical medicines domestically, and how the Medicines for All Institute is reshaping the way drugs are made by reducing costs and streamlining production. Drawing on his extensive experience in the pharmaceutical industry, Dr. Gupton discusses the ongoing challenges of ensuring that lifesaving medicines reach those in need worldwide.

Listen now on your favorite podcast platform:

Apple: https://apple.co/40fndE6
Spotify: https://spoti.fi/3BUBe00
Amazon Music: https://amzn.to/4hbHYqm
TuneIn: https://bit.ly/2M60Wmx

The discussion also touches on the future of pharmaceutical manufacturing, from emerging technologies like continuous processing to green chemistry's role in creating more sustainable production methods. Dr. Gupton provides insight into how partnerships and collaboration are vital to accelerating these innovations.

Join the conversation to hear about the impactful work being done to transform drug manufacturing and access on a global scale.

TDR: BioHealth Capital Region Forum: A recap of innovation and collaboration

By: Tammi Thomas, Chief Development and Marketing Officer, TEDCO

The 2024 BioHealth Capital Region Forum (BHCRF) once again solidified its position as the premier gathering for the life sciences industry in the region. Marking the tenth year of the impactful event, hundreds of industry leaders, government officials, academic researchers and investors were brought together to discuss the latest trends, challenges and opportunities in the field.

BrainScope Completes Proof-of-Concept for Groundbreaking Early Alzheimer’s Prediction Biomarker

ROCKVILLE, Md.--(BUSINESS WIRE)--BrainScope, a leader in brain diagnostics, today announced the successful completion of the proof-of-concept phase for a novel brain activity-based biomarker for the prediction of onset of Alzheimer’s disease at its earliest stage in normal elderly individuals with memory complaints. This breakthrough was supported by an investment from the Alzheimer’s Drug Discovery Foundation (ADDF).

Cartesian Therapeutics Announces Presentation of Results from Phase 2b Trial of Descartes-08 in Patients with Myasthenia Gravis at the 2024 MGFA Scientific Session of the AANEM Annual Meeting

Company continues to expect to hold an End-of-Phase 2 meeting with the FDA by year-end

GAITHERSBURG, Md., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced the presentation of data from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG) during the 2024 Myasthenia Gravis Foundation of America (MGFA) Scientific Session of the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting being held today in Savannah, Georgia. Positive topline results from the trial were previously announced in July 2024. A copy of today’s presentation will be available in the Publications and Presentations section of the Company’s website.

USP Acquires Stratix Labs, Enhancing Its Microbiology Portfolio with Innovative Technology

ROCKVILLE, MD - October 21, 2024 – Today, the U.S. Pharmacopeia (USP) announced the acquisition of Stratix Labs, a microbiology technology company based in Saint Paul, MN. This acquisition marks a significant milestone for USP’s portfolio, as it will expand its microbiological solutions supporting microbial contamination control with broad applications across pharmaceuticals, including biologics and compounded medications.

Microbiological quality control is essential to ensure fundamental contamination control measures are in place during pharmaceutical production and preparation. Increased demand and expedited timelines require the industry to identify and implement new approaches to quality control throughout the drug production process, particularly for sterile products. By acquiring Stratix Labs, USP will be better equipped to help drug manufacturers, developers, and compounding entities address industry gaps in microbial contamination control strategies, mitigating the risk of contaminated products reaching patients.

Seraxis Announces FDA IND Allowance for Clinical Study of SR-02 Replacement Islets for Type 1 Diabetes

GERMANTOWN, Md., October 15, 2024 (Newswire.com) - Seraxis Inc., a clinical-stage regenerative medicine company, has received the FDA’s allowance of an Investigational New Drug (IND) application for a Phase I/II clinical study of its novel islet replacement therapy SR-02. SR-02 is the first reprogrammed stem cell-derived pancreatic product candidate allowed by the FDA for testing in humans as a potential functional cure for insulin-requiring diabetes.

MacroGenics Enters Into Agreement With TerSera Therapeutics for the Sale of MARGENZA®

ROCKVILLE, Md. & DEERFIELD, Ill.--(BUSINESS WIRE)--Oct. 22, 2024-- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, and TerSera Therapeutics LLC, a privately-held biopharmaceutical company with a focus in oncology and non-opioid pain management, announced today that they have entered into an agreement in which TerSera will acquire global rights to MARGENZA® (margetuximab-cmkb).

REGENXBIO Shares Positive Phase II Data on Wet AMD Treatment at AAO 2024

ROCKVILLE, Md., Oct. 21, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced positive data from the Phase II fellow eye sub-study evaluating the subretinal delivery of ABBV-RGX-314 in patients with bilateral wet age-related macular degeneration (wet AMD). The new data were presented at the American Academy of Ophthalmology (AAO) meeting by Arshad Khanani, M.D., M.A., FASRS, Director of Clinical Research at Sierra Eye Associates, Reno, NV.

Supernus Announces Promising Data from Open-Label Phase 2a Study of SPN-820 in Adults with Major Depressive Disorder

ROCKVILLE, Md., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced data from its exploratory open-label Phase 2a clinical study of SPN-820 in adults with major depressive disorder. The study examined the safety and tolerability of SPN-820 2400 mg given once every 3 days as an adjunctive treatment to the current baseline antidepressant therapy, as well as assessed the rapid onset of improvement in depressive symptoms. The analysis is based on 40 enrolled subjects, of which 38 completed the 10-day treatment period.

VEDP: University Partnerships Accelerate Innovation in Albemarle County, VA

Federal agencies, defense contractors spur growth at Rivanna Station, North Fork Discovery Park
On 462 acres in Albemarle County, a plot of land along U.S. Route 29 adjacent to a federal intelligence hotspot is the latest addition to a growing cluster of industries coming to define the Charlottesville area. County officials identified the plot as a place where academic institutions, private industry focused on defense and biotech, and government agencies could come together, develop partnerships, and benefit from their proximity and talent. The county Board of Supervisors finalized the agreement to purchase the property in late 2023, the largest parcel of land purchased in the county’s history.

The new plot is adjacent to Rivanna Station, the aforementioned intelligence cluster, and directly across from the University of Virginia’s (UVA) North Fork Discovery Park, another parcel that spans more than 500 acres and hosts a similar range of organizations. Together, the growing Rivanna Station and North Fork campuses allow the industries to grow in a region increasingly known for defense and biotech companies. The county plans to use the land to establish what it’s calling an Intelligence and National Security Innovation Acceleration Campus, where defense contractors, the U.S. Department of Defense, and academia can cooperate to solve national security problems.

Winners announced in $300,000 pediatric medical device competition focused on pediatric cardiology

WASHINGTON, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Six medical technology innovators focused on pediatric cardiology were selected to receive grants of $50,000 each in the “Make Your Medical Device Pitch for Kids!TM” competition in Toronto. The funds will help awardees bring their devices to the market and improve care for children with heart conditions.

Technical.ly: New life sciences building is the latest step in Jane Shaab's mission to make Baltimore embrace itself

AFP: Virginia Tech, Children’s National Hospital partnering to advance healthcare with AI

By Rebecca Barnabi: Published date:October 14, 2024 - Thought leaders from academia and medical practice explored how artificial intelligence can advance children’s health care at the second annual Children’s National Hospital-Virginia Tech Symposium on AI for Pediatric Health at the Children’s National Research & Innovation Campus in Washington, D.C.

Rowland Illing, chief medical officer and director of international public sector health at Amazon Web Services (AWS), discussed the transformative impact of AI, machine learning and cloud technology.

BioBuzz: Advancing Pediatric Medical Countermeasures Through the Newly BARDA-Funded Accelerator, SPARK for Innovations in Pediatrics

This article originally appeared in the Association for the Advancement of Medical Instrumentation’s (AAMI) new Insights into Innovation series is authored by Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National and principal investigator of SPARK Innovations in Pediatrics, the BARDA Accelerator Network Hub for Special Populations.

October 21, 2024- In the realm of public health and emergency preparedness, one of the most pressing challenges is ensuring that children and special populations are adequately protected. The ongoing global threats—whether pandemics, natural disasters, or acts of terrorism—have highlighted the vulnerability of these groups. Children in particular face unique physiological and developmental risks that necessitate specialized medical countermeasures (MCMs). Yet, the development of pediatric-specific MCMs has long been hindered by significant regulatory, ethical, and financial challenges.

Addressing these concerns, the SPARK Accelerator, led by Children’s National Hospital in partnership with the Biomedical Advanced Research and Development Authority (BARDA), is poised to accelerate the development of medical countermeasures tailored to the pediatric population. With a consortium of partners, including BioHealth Innovation (BHI), CIMIT, University Hospitals Rainbow Babies and Children’s Hospital, and strategic industry players such as Johnson & Johnson Innovation JLABS, SPARK is creating a global hub that primarily focuses on innovations for children.

BIO Investor Forum opens with encouraging news on financing

The tide has been rising in biotech investment in 2024—though it has not lifted all boats equally.

While the volume of investment improved in the first half of 2024, much of it went to a few “mega deals,” leaving many promising small biotechs still seeking funding, according to data presented during the Oct. 15 opening panel of the 2024 BIO Investor Forum in San Francisco, hosted by the Biotechnology Innovation Organization (BIO).

Still, the situation is improving, according to panelists in the session, “Understanding the Fundraising Environment for Biotech Companies,” which was moderated by Jesse Essaff, Director, Life Science & Healthcare, Commercial Banking – HSBC Bank USA.