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.

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.

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.

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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.

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.

Baltimore’s reputation for life sciences innovation largely rests on the people, products and capital from its biggest research universities

Even with the resources of institutions like the University of Maryland (UM) BioPark, the city’s biotech boosters spent years trying to clear a hurdle they said stifled the sector’s development: a lack of wet lab space and related facilities where scientists and spinouts could actually work.

Come January 2025, more of this space will open up in West Baltimore, just across Martin Luther King Jr. Boulevard from downtown, when UM BioPark launches the first phase of 4MLK. 

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.

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.

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.

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).

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.  

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.

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.

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.

BALTIMORE, MD, October 14, 2024 – BioBuzz Networks, Inc. and ScienceWerx, Inc., a 501c(3) nonprofit organization based in Frederick, MD, have entered into a strategic technology partnership. Through this new partnership, ScienceWerx will lead the technology development of BioBuzz’s AI-powered life science community platform and talent marketplace. The companies will also be working together to deploy their collective expertise to support regional economic and workforce development initiatives within emerging innovation ecosystems.

COLUMBIA, Md., (October 10, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $100,000 Pre-Seed Builder Fund investment in PerSoN, a company creating digital health solutions to support complex mental health conditions. Businesses receiving an investment from TEDCO’s Pre-Seed Builder Fund, housed under TEDCO’s Social Impact Funds, receive access to a variety of benefits designed to nurture business growth.

Italy, October 10th, 2024 – For the fourth consecutive year, PQE Group is among the winners in the 7th edition of the Best Managed Companies Award, which recognizes entrepreneurial excellence in Made in Italy. This award is promoted by Deloitte Private in collaboration with ELITE-Euronext Group, Piccola Industria Confindustria, and with the methodological and strategic support of ALTIS Graduate School of Sustainable Management at the Catholic University of the Sacred Heart.

Olivia Schwern - Associate @ J.P. Morgan | Life Sciences Private Capital

Our take from Q3, in short:

• Attracting new LP capital is still a feat. According to Carta, less than 10% of 2021 private funds have returned any capital to their LPs after three years, limiting allocators' ability to assess new opportunities.
• Healthcare has been a consistent bright spot. Over 1-in-4 LP dollars deployed into VC in 2024 have gone into healthcare-focused funds – the highest share in over five years.
• This dynamic has led to a revival in deal activity. If the current pace holds, private healthcare companies will raise ~$70 billion in 2024, an impressive >40% pickup from last year.
• Valuations continued to find support. We still believe life sciences investors today are more likely to get into quality companies at attractive prices relative to recent years.
• Finally, the healthcare exit market is staging a comeback. Q3 saw 97 VC-backed companies exit – 18 via IPO, 79 via M&A.
  
  

BURLINGTON, Mass., October 09, 2024--(BUSINESS WIRE)--MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, has opened its new €290 million biosafety testing facility in Rockville, Maryland, USA. Biosafety testing and analytical development are fundamental components of drug development and commercialization for traditional and novel modalities. Global demand for these services is growing at a double-digit rate¹.

Children’s National Hospital in Washington, D.C., was ranked as a top hospital in the nation by the U.S. News & World Report 2024-25 Best Children’s Hospitals annual rankings. This marks the eighth straight year Children’s National has made the Honor Roll list. The Honor Roll is a distinction awarded to only 10 children’s hospitals nationwide.

This year, U.S. News ended ordinal rankings on its Honor Roll. Instead of assigning a numerical rank from 1 to 10, all hospitals on the Honor Roll will be recognized as having attained the highest standards of care in the nation.

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CHARLOTTESVILLE, Va., October 8, 2024 -- AMPEL BioSolutions announced a precision medicine blood test that could save lives by predicting heart disease before it happens and providing decision support for prophylactic therapies.  Inflammatory and immune system abnormalities identified in the blood of individuals predisposed to heart disease by AMPEL two years ago were confirmed and extended in the peer-reviewed Cell iScience paper announced today. Examination of genes expressed in single cells isolated from atherosclerotic coronary artery plaques revealed biomarkers that can be measured by AMPEL's CardioGENE^® blood test.

Program aims to reduce drug safety failure rate and improve efficacy prediction before clinical trials start 

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new funding opportunity through its Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST) program. CATALYST intends to create human physiology-based computer models to accurately predict safety and efficacy profiles for Investigational New Drug (IND) candidates.  

The Maryland MedTech ecosystem is unique for several reasons, particularly its rich blend of resources, institutions, and infrastructure that support innovation in medical technology. Here are some key features that make it stand out:

1.      Proximity to Leading Research Institutions

• • Johns Hopkins University and the University of Maryland are world-class research institutions that have robust medical and biomedical engineering programs. These universities foster cutting-edge research and serve as breeding grounds for MedTech innovation.

• • Maryland is also home to the National Institutes of Health (NIH), the world’s largest medical research agency, which provides funding, research collaborations, and access to critical expertise.

2.      Federal Agencies and Regulatory Bodies

• • The presence of FDA headquarters in Maryland gives local companies close access to regulatory experts. This is crucial for MedTech startups, as navigating the regulatory approval process is often one of the biggest challenges they face.
  • Other federal agencies like the Centers for Medicare & Medicaid Services (CMS) and various defense agencies that have a stake in health technologies are also located nearby.

3.      Vibrant Start-up and Investment Scene

• Maryland’s ecosystem has a growing number of incubators and accelerators focused on MedTech.  Notable ones include the LaunchPort Accelerator, which supports medical device startups by providing them with the resources to prototype, manufacture, and commercialize their innovations.
• There is strong financial support from angel investors and venture capital firms specializing in healthcare technologies, creating opportunities for funding and scaling businesses.

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Federal Reserve Bank of Richmond’s R. Andrew Bauer and Fulton Bank’s Joe Durham will be the morning keynote at the upcoming premier event

COLUMBIA, Md., (October 3, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced the two morning keynote speakers for its Entrepreneur Expo – R. Andrew (“Andy”) Bauer of the Federal Reserve Bank of Richmond and Joe Durham of Fulton Bank. The upcoming event will take place on December 4, 2024, at the Renaissance Baltimore Harborplace Hotel.

The NIH Common Fund is funding five new research awards to Health Equity Research Hubs that will support community-led research projects. These awards total more than $37 million over five years, pending availability of funds.

Structural factors in communities such as access to education, health care, and social context shape the health of those communities and contribute to ongoing health disparities. Developing new programs that target the causes of these disparities is integral to improving equal access to health resources. The needs of communities vary, so input from individuals and local leadership is critical to develop successful, sustainable initiatives. The Community Partnerships to Advance Science for Society (ComPASS) Program was designed for community-based organizations to lead the way in researching, designing, implementing, and assessing projects that address community needs and reduce health disparities.

GAITHERSBURG, Md., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it entered into a new credit agreement on September 30, 2024 providing for an asset-based revolving loan facility (ABL) with the lenders party thereto and Wells Fargo Bank, National Association, as administrative agent. The credit agreement provides for revolving loan commitments in an aggregate principal amount up to $100 million (availability is based on a borrowing base set forth therein) with a fixed maturity date of September 30, 2029, subject to early maturity triggers based on the maturity of its other material indebtedness. The new credit facility brings additional liquidity to support Emergent’s multi-year transformation plan. As of September 30, 2024, Emergent had a cash balance of approximately $150 million and undrawn access to $100 million under the ABL.

NIJMEGEN, Netherlands and BOSTON, Oct. 1, 2024 /PRNewswire/ -- Tagworks Pharmaceuticals BV ("Tagworks"), a precision oncology company using its proprietary Click-to-Release treatment platform to develop a new standard of care for patients suffering from solid tumors by targeting clinically validated tumor markers that so far have remained out of reach of current therapies, today announced the appointment of Ken Mills as Chief Executive Officer and member of the Board of Directors. As part of this planned CEO leadership transition, Marc Robillard, Ph.D., the founding CEO of Tagworks, will continue in the role of Chief Scientific Officer and as a board member.

WASHINGTON, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Ten medical technology innovators focused on pediatric cardiology have been selected to compete for $300,000 in grants in the “Make Your Medical Device Pitch for Kids!TM” competition on Oct. 14 in Toronto, Canada.  

The competition is presented by the Alliance for Pediatric Device Innovation (APDI), a nonprofit consortium led by Children’s National Hospital and funded through the Food and Drug Administration (FDA), and Additional Ventures, a nonprofit focused on accelerating research progress and improving clinical care for individuals born with single ventricle heart defects. Selected by an internal committee, ten finalists will compete for up to $50,000 each in grant funding and opportunities to access support services and technical expertise provided by APDI and Additional Ventures, including engineering, regulatory, reimbursement, clinical trials study design and data science services.  

Join us for our Fourth Annual IPWatchdog LIVE Conference

Bringing together the intellectual property community – from politicos, to business executives, to attorneys, and inventors, IPWatchdog LIVE gives everyone from all sides of the debate the opportunity to have a fulsome discussion of the most important issues facing the industry from their perspectives. With a focus on exceptional networking opportunities, and A+ content. Our philosophy has always been that “Content is King”, and that will show clearly at this Conference. With A+ speakers and top-level content, we will create a center of gravity to attract the IP community. Making networking a priority, we will have THREE (3) networking cocktail receptions, two breakfasts, two lunches, and 5 networking breaks, where attendees can and do mingle with numerous high-ranking in-house counsel (just look at our speaker list), current and former government officials, current and former Judges, top lobbyists, and Hill Staffers. #IPWLIVE2024

GAITHERSBURG, Md., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced completion of patient enrollment in IMPACT, its Phase 2b biopsy-driven trial evaluating pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) and provided an update on additional development and regulatory initiatives related to pemvidutide.

By Alan Kline – Senior Editor, Washington Business Journal - Sep 26, 2024 - Children’s National Hospital has landed another large gift from the government of the United Arab Emirates (UAE), this time to help support prenatal and neonatal care and research. 

The $35 million donation, announced Thursday, comes some five years after the UAE donated $30 million to help Children’s build its research and innovation campus at the former Walter Reed Medical Center and 15 years after it provided a gift of $150 million for construction of the Sheikh Zayed Institute for Pediatric Surgical Innovation, named for the UAE’s founding father.

The UAE’s support of Children’s National dates to the early 1990s, when the UAE opened a medical office in D.C. Since then, the partnership has yielded 82 U.S. patents and “countless medical breakthroughs for kids and their families,” Children’s National said in a news release. 

The UAE government also counts on Children’s National to provide care to dozens of Emirati families that travel to D.C. each year to access the hospital’s advanced services and treatments. 

The donation, among the largest in Children's history, is biggest the hospital has received since Michelle Riley-Brown replaced Kurt Newman as president and CEO about 15 months ago. Just before Newman retired, an anonymous family donated $96 million to help fund research and treatments for pediatric brain tumors. 

“I am deeply grateful for the UAE’s most recent gift,” Riley-Brown said in a statement. “The contribution will positively impact children and families and support the teams of researchers and specialists who dedicate their lives to developing innovative medical care.”

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GAITHERSBURG, Md., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) (“Emergent”) today announced that two contract options have been secured to procure additional treatment courses of TEMBEXA^® (brincidofovir) to sustain the U.S. government’s national preparedness posture against human smallpox. TEMBEXA^® is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. The order is valued at $67.4 million and executes procurement options CLIN0004A and CLIN0005A under Emergent’s existing 10-year contract.