BHI Weekly News Archives

WASHINGTON, Dec. 11, 2024 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (60 Degrees Pharmaceuticals or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today it has entered into a clinical trial agreement with Brigham and Women’s Hospital (BWH) in Boston to conduct a double-blind, placebo-controlled study evaluating the safety and efficacy of tafenoquine in combination with standard of care treatment for hospitalized babesiosis patients.

GAITHERSBURG, Md., Dec. 13, 2024 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced progress in Q4 2024 advancing its corporate growth strategy through its partnership with Sanofi. The Company has achieved a milestone associated with its Phase 2/3 clinical trial for its COVID-19 vaccine in children, triggering the first $50 million milestone payment from Sanofi.

The National Cancer Institute (NCI) Technology Transfer Center is hosting a webinar on an exciting new technology that could revolutionize MRI metabolic imaging. Scheduled for Wednesday, December 18, 2024, at 11:00 AM ET, this free webinar will introduce a novel Signal Amplification By Reversible Exchange (SABRE) catalyst technology, co-developed by the National Heart, Lung, and Blood Institute (NHLBI) and NCI. This innovation promises to enhance MRI imaging capabilities, enabling groundbreaking advancements in the detection and monitoring of cancer, cardiovascular disease, stroke, and traumatic brain injury. 

ANNAPOLIS, Md., Dec. 10, 2024 /PRNewswire/ —  Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today that the U.S. Patent and Trademark Office (USPTO) has granted the company a patent covering compositions and methods of use for the drug formulation of Zabalafin Hydrogel (AB-101a) for atopic dermatitis (AD). The patent covers Zabalafin Hydrogel through 2042 and is eligible for listing in the U.S. Food and Drug Administration’s (FDA) Orange Book, which provides additional protective benefits once Zabalafin Hydrogel receives FDA approval.

Multiplexed, extraction-free, full-length library preparation technology facilitates large-scale RNA sequencing, combining ever more content with high throughput

FREDERICK, Md., Dec. 9, 2024 /PRNewswire-PRWeb/ — Alithea Genomics, a leader in the field of large-scale RNA sequencing and transcriptomics, announced today the launch of MERCURIUS™ Full-Length DRUG-seq library preparation technology, which combines, for the first time, massive sample multiplexing, an extraction-free workflow and full transcript coverage in a unique RNA-seq workflow. The technology is compatible with both 96- and 384-well plate formats and up-to 384 full-length RNA-seq library preps can be performed in a single tube without RNA isolation.

MSCRF invites applications across seven key grant programs to propel innovation in regenerative medicine

COLUMBIA, Md. (November 14, 2024) – The Maryland Stem Cell Research Commission (MSCRC) announces the release of a Request for Applications (RFA) for the Maryland Stem Cell Research Fund’s (MSCRF) second funding cycle of Fiscal Year 2025 (FY25). This funding opportunity spans seven diverse grant programs: Manufacturing Assistance, Clinical, Validation, Commercialization, Discovery, Fellowship and Launch. The application deadline is January 13, 2025.

MSCRF grants support both young and established scientists, companies and research organizations to accelerate and advance the commercialization of innovative stem cell technologies for positive impact on human lives. 

FREDERICK, Md., Dec. 03, 2024 (GLOBE NEWSWIRE) — Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced updated efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with generalized myasthenia gravis (MG) and provided details on the design of its planned Phase 3 AURORA trial. The updated data will be presented today at the 2^nd Annual Cell Therapy for Autoimmune Disease Summit being held in Philadelphia.

There are several keys to successful entrepreneurship—a great idea that solves a unique problem, the willingness to take risks, leadership skills, networking, and, of course, capital. The last element listed can be especially challenging for those without significant savings, investment from wealthy family members, or generational wealth, says Graham Dodge, vice president, Venture Development at TEDCO, (Maryland Technology Development Corporation), an independent instrumentality of the State of Maryland to facilitate the creation of businesses and support their growth in all regions of the State.

Firm Remains Focused on Partnering with Healthcare Business Owners on Control Growth Transactions

WASHINGTON, Nov. 20, 2024 /PRNewswire-PRWeb/ — NaviMed Capital, a Washington, DC-based private equity firm focused exclusively on the healthcare industry, today announced the closing of its third fund, NaviMed Partners III (“Fund III”). The substantially oversubscribed new fund closed at its hard cap of $450 million of commitments. With the new fund, NaviMed now manages more than $850 million of capital commitments.

NaviMed will continue to focus on control investments in fast growing lower middle-market healthcare companies. The firm specializes in acquiring businesses that provide business process outsourcing services to hospitals and other healthcare providers, health insurers, and the pharmaceutical and medical device industries. NaviMed seeks to invest in profitable private companies with up to $10 million of EBITDA and double-digit annual revenue growth.

The Biomedical Advanced Research and Development Authority (BARDA) has announced the launch of the SPARK Hub Prize Challenge, offering up to $50,000 in funding to innovators working on medical countermeasures (MCMs) designed specifically for children. The challenge supports technologies and products that enhance health security for pediatric populations and is open for submissions until December 16, 2024. https://www.mcm4kids.org/funding/

About BARDA and the Challenge
BARDA plays a pivotal role in safeguarding public health by advancing the development of MCMs for various health security threats, including chemical, biological, radiological, and nuclear (CBRN) hazards, pandemic influenza, and emerging infectious diseases. The SPARK Hub Prize Challenge is an extension of this mission, focusing on solutions tailored to pediatric needs. BARDA’s aim is to ensure that medical countermeasures are accessible to all segments of the population, including children, who have unique requirements during public health emergencies.

MSCRF invites applications across seven key grant programs to propel innovation in regenerative medicine

COLUMBIA, Md. (November 14, 2024) – The Maryland Stem Cell Research Commission (MSCRC) announces the release of a Request for Applications (RFA) for the Maryland Stem Cell Research Fund’s (MSCRF) second funding cycle of Fiscal Year 2025 (FY25). This funding opportunity spans seven diverse grant programs: Manufacturing Assistance, Clinical, Validation, Commercialization, Discovery, Fellowship and Launch. The application deadline is January 13, 2025.

MSCRF grants support both young and established scientists, companies and research organizations to accelerate and advance the commercialization of innovative stem cell technologies for positive impact on human lives. 

COLUMBIA, Md., (November 12, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 Seed Funds investment in NextStep Robotics. TEDCO’s Seed Funds aim to reach prospective businesses showing potential of being venture fundable or other forms of corporate venture, such as follow-on funding.

“Foot drop is a disability that results from underlying neurological or muscular injuries and affects millions of Americans each year,” said Bradley Hennessie, CEO of NextStep Robotics. “With traditional treatments, patients were left with uncomfortable orthotics or assistive devices. However, with this latest investment from TEDCO, we are excited to continue moving forward to provide more appealing solutions and support patients and physical therapists alike.”

WASHINGTON, D.C., (November 14, 2024) – Johnson & Johnson (NYSE: JNJ) today announced results from additional analyses of the Phase 2 DAHLIAS study highlighting improvement in key measures of disease activity and significant IgG reduction by over 77% following treatment with investigational nipocalimab in adult patients with moderate-to-severe Sjögren’s disease (SjD). These data were included in a plenary session presentation (Abstract #2527) and two posters (Abstracts #1427 and #2294) and are among the Company’s 43 oral and poster presentations at the American College of Rheumatology (ACR) Convergence 2024.

LONDON, Nov. 12, 2024 /PRNewswire/ — Ascend Advanced Therapies (Ascend), a gene-to-GMP development partner, has partnered with EW Healthcare Partners to expand the footprint and capabilities of the company in the US and to continue investing further in infrastructure. Advanced BioScience Laboratories (ABL), a biotherapy, oncolytic and viral vector contract development, and manufacturing organization (CDMO) located in Rockville, MD, a portfolio company of EW Healthcare Partners, will become part of Ascend. EW will also make a significant capital investment in Ascend to support continued growth of the company.

The NIH Office of Technology Transfer is recruiting for a Deputy Director (GS-15 level) to lead its License Compliance and Administration Unit. This critical role involves managing NIH’s large and diverse invention license portfolio.

Position Details:
Title: Supervisory Technology Transfer Specialist (GS 601-15)
Location: Montgomery County, MD
Open Date: Monday, November 18, 2024
Close Date: Friday, November 22, 2024

This is an All-Sources announcement with two application pathways:
? Current or former USG employees: https://lnkd.in/eYJuHMpV
? U.S. citizens: https://lnkd.in/etYHqykM

Don’t miss this chance to join a dynamic team and make an impact on technology transfer at NIH!

GAITHERSBURG, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and agreement on the design of a Phase 3 registrational program for its product candidate, pemvidutide, in the treatment of obesity.

GAITHERSBURG, Md., Nov. 11, 2024 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Novavax’s Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The FDA has cleared the Company to begin enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues. Novavax will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible.

The Accelerate Investor Conference spurs the region’s innovation and startup ecosystem engagement to a new level and showcases the Virginia, Maryland, and metropolitan Washington, D.C., region as a destination for business development, venture investment, and job creation.

Each year the event grows in size and stature. This year Mason Enterprise, which plans the event, reports there were 480 registered attendees, 19 speakers, 48 company pitches, 72 investors judged and participated, and 14 student teams that pitched. 

The competition targeted entrepreneurs with early to mid-seed stage, high-growth businesses with the potential to have an immediate and positive impact on our local economy, as well as student concepts with longer-term business viability. After days of networking, engagement, and education, the winners were selected.

The Indo US Bridging RARE Summit 2024 is set to be an unmissable event for those dedicated to advancing rare disease research and fostering global collaborations. Taking place from November 16-18, 2024, this second annual summit is hosted by the Indo US Organization for Rare Diseases (IndoUSrare) in partnership with AIIMS (All India Institute of Medical Sciences, New Delhi) and other key partners. The main venue is the Indian National Science Academy (INSA) Campus, New Delhi, with an opening gala at the outdoor AIIMS Swimming Pool Venue on the evening of November 16th. Virtual participation will be available, offering opportunities for online networking, exhibits, and posters.

GAITHERSBURG, Md., Oct. 29, 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), announced today that the first three patients in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma have been successfully dosed.

Ropidoxuridine (IPdR) is Shuttle Pharma’s lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure. Shuttle has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.

Germantown, Maryland, and Venlo, the Netherlands, Nov. 04, 2024 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Meningitis/Encephalitis Panel for clinical use.

This marks the fourth QIAstat-Dx syndromic test to receive U.S. regulatory clearance in 2024.

Meningitis (inflammation of the membrane surrounding the brain and spinal cord) and encephalitis (inflammation within the brain) are medical emergencies that require immediate treatment. One in five cases of bacterial meningitis results in permanent complications, such as hearing loss, brain damage and seizures and without prompt treatment, about half of patients will die.

Baltimore, MD (October 24th, 2024) – Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced the closing of its $15 million Series A-2 financing. The round attracted several new institutional investors, strong participation from existing shareholders, and industry veterans in vascular and dialysis. New investors include Unorthodox Ventures, GenHenn Capital, JSTAR Capital, Oakwood Circle Ventures, Riptide Ventures and Partners Investment.

ROCKVILLE, Md., Oct. 23, 2024 /PRNewswire/ — Rise Therapeutics announced today that it has received funding from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institute of Health (NIH) to enable infrastructure improvement that will scale GMP production and accelerate quality assurance (QA) and quality control (QC), significantly enhancing its biologics drug manufacturing capabilities. This Commercial Readiness Pilot (CRP) Program SBIR award will also support Phase 2 clinical GMP manufacturing to advance Rise Therapeutics’ R-3750 program currently completing a Phase 1 proof-of-concept clinical trial in patients suffering from ulcerative colitis.

FREDERICK, Md., Oct. 23, 2024 /PRNewswire/ — Theradaptive, a privately held, clinical stage biologics company developing protein therapeutics for spine, orthopedics, soft tissue repair and targeted immuno-oncology, announced today that OsteoAdapt™ SP  has received the Gold Level Award for Best Technology in Spine 2024 by Orthopedics This Week.

COLUMBIA, Md., (October 24, 2024) –– TEDCO, Maryland’s economic engine for technology companies, announces the “Breaking Barriers and Building Futures: The Evolution of Women Entrepreneurs in Maryland” session at the 10^th Entrepreneur Expo, taking place on December 4, 2024, at the Renaissance Baltimore Harborplace Hotel.

The dynamic growth of women-led entrepreneurship in Maryland will take center stage in this insightful panel discussion featuring Jasmine Clemons, director of the Maryland Board of Public Works, Danette Nguyen, managing director of the Maryland Women’s Business Center and Samantha Scott, PhD, CEO and founder of JuneBrain. The conversation will explore the unique challenges women face in today’s business landscape, with a particular focus on access to capital, scaling strategies and the support systems necessary for sustained success.

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced the teams selected by its Sprint for Women’s Health to receive awards. The agency committed over $110 million to fund solutions for health conditions that uniquely or disproportionately affect women. This effort will advance the White House Initiative on Women’s Health Research and help spur the type of innovation and private sector engagement long needed to improve women’s health.  

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.

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.

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.

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.  

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.  

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.

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.

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.

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.

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.