ROCKVILLE, Md., Jan. 30, 2025 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing solutions to advance the discovery, development and commercialization of next-generation cell therapeutics announced today the acquisition of SeQure Dx, a market leader of on-target and off-target editing assessment services for cell and gene therapies.

This strategic acquisition strengthens MaxCyte’s ability to serve ex vivo and in vivo cell and gene therapy (CGT) developers with an innovative suite of tools and services spanning early R&D through clinical development and commercialization. By integrating SeQure Dx into MaxCyte, Maxcyte will expand its service offerings and leverage its commercial and field application scientist teams to work with developers earlier in their research processes. SeQure Dx is revenue generating and expected to be accretive to MaxCyte’s revenue growth.

MONTGOMERY COUNTY, Md. — Businesses in Maryland’s Montgomery County experienced a surge in investment funding in 2024. Mergers and acquisitions, venture capital and private funding deals totaled $2.9 billion, a 36% increase over 2023’s total of $2.2b. Spanning 106 deals across 96 companies, this surge in mergers and acquisitions, venture capital, and private investment reflects Montgomery County’s continued prominence as a regional economic leader. 

Diverse Industries Driving Growth 

HANOVER, MD, Jan. 27, 2025 (GLOBE NEWSWIRE) — Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced the pricing of its “reasonable best efforts” public offering with participation from the Company’s Chief Executive Officer, certain board members, and existing institutional investors of the Company, along with a healthcare focused institutional investor, consisting of 8,050,672 shares of common stock (or pre-funded warrants in lieu thereof) and accompanying Series A warrants to purchase up to 8,050,672 shares of common stock (or pre-funded warrants in lieu thereof) and Series B warrants to purchase up to 4,025,336 shares of common stock at a combined purchase price per share (and accompanying warrants) of $0.615 for the institutional investors and $0.7975 for the Company’s Chief Executive Officer and certain board members.

ETC Baltimore, dedicated to elevating Baltimore as a national leader in tech startups, announces the opening of its inaugural ETC Venture Hub at Connect Labs Baltimore in the newly constructed 4MLK Building in the University of Maryland BioPark. This milestone marks a significant step in Baltimore’s efforts to strengthen its ecosystem for life science startups and attract high-potential companies to the city.

The ETC Venture Hub at Connect Labs Baltimore is a dedicated space designed to provide early-stage life science companies with the technology, capital, talent and resources needed to successfully grow and scale. Offering desk space, expert support, and a collaborative community, the hub serves as a launchpad for startups. This is part of ETC’s broader strategy to establish multiple footprints throughout the city. By expanding its reach, ETC aims to create a more inclusive and robust entrepreneurial ecosystem, ensuring innovators in all areas of Baltimore have access to the tools and support they need to thrive.

LEIDEN, Netherlands, January 28, 2025 / Biotech Newswire / — MIMETAS, a global leader in human disease modeling, has launched OrganoPlate UniFlow (UF), the first commercially available unidirectional, gravity-driven pumpless flow system for drug discovery and disease research. This innovative platform debuts at SLAS 2025 as a key addition to MIMETAS’ service portfolio.

OrganoPlate UF addresses challenges in traditional flow systems by enabling physiologically accurate tissue models that replicate natural biological conditions. With unidirectional, gravity-driven flow, this system eliminates the need for external pumps, simplifying operation while enhancing model accuracy. Supporting up to 512 chips in a single setup, the technology is ideal for rigorous scientific studies and large-scale screening, accelerating research without compromising biological relevance.

In this episode of BioTalk with Rich Bendis, Dr. Kolaleh Eskandanian, Vice President and Chief Innovation Officer at Children’s National Hospital, discusses her work driving pediatric healthcare innovation. Dr. Eskandanian introduces the BARDA SPARK Accelerator, a groundbreaking initiative focused on advancing medical countermeasures for children, and explains how it aligns with Children’s National’s mission to lead in pediatric healthcare innovation.

She also highlights the unique challenges in developing pediatric medical countermeasures and the importance of partnerships with organizations like Rainbow Babies, Mass General, and others. Additionally, Dr. Eskandanian shares insights into the hospital’s role in fostering innovation through the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) and the Children’s National Research and Innovation Campus.

Join us for an engaging conversation about the future of pediatric healthcare, the opportunities for innovation, and how the SPARK Accelerator is paving the way for advancements that will improve the lives of children worldwide.

Listen now via your favorite podcast platforms:
Apple: https://apple.co/4gcz9L3
Spotify: https://spoti.fi/3PHRYuP
Amazon Music: https://amzn.to/4h7PzWI
YouTube Music: https://bit.ly/4hp4WK0
TuneIn: https://bit.ly/42oIoVk

CES2025 once again brought the world’s brightest minds and groundbreaking innovations to Las Vegas. With over 4,500 exhibitors and more than 141,000 attendees, the event showcased technologies poised to shape industries across the globe. Among these, the health and wellness sector, centered at the Venetian Expo Center, stood out as a beacon of innovation. John Reinhart, Entrepreneur-in-Residence (EIR) at BioHealth Innovation (BHI), attended alongside colleagues from the National Institute on Aging (NIA) to explore the transformative field of AgeTech.

AgeTech—focused on enhancing the quality of life for an aging population—has rapidly emerged as a critical area of innovation. With 1 in 4 people currently over the age of 50, and that number projected to rise to 1 in 3 by 2050, the need for solutions that address aging-related challenges is urgent and global. Reinhart’s insights from CES2025 underscored the immense potential of this growing field.

The AgeTech Collaborative from AARP led the way in promoting innovation at CES2025. With its pavilion now in its third year, AARP highlighted the collaborative ecosystem it has built to foster solutions for the 50+ demographic. Boasting 111 investor organizations, 105 business services partners, 68 testbed collaborators, and 177 startups, the growth of the Collaborative has been remarkable. Its programming featured a pitch competition and networking reception, providing a platform for startups to connect and showcase their solutions.

COLLEGE PARK, Md., January 14, 2025–(BUSINESS WIRE)–IonQ (NYSE: IONQ), a leader in the quantum computing and networking industries, today announced a landmark partnership with the University of Maryland and the State of Maryland with the aim to establish Maryland as the “silicon valley” of the quantum computing industry. The proposed initiative will aim to fuel the growing quantum economy of the U.S. capitol region, provide access to IonQ’s cutting-edge quantum technology, and dramatically strengthen Maryland’s workforce with new quantum-focused jobs.

As part of today’s announcement of the “Capital of Quantum” initiative’s goal of catalyzing more than $1 billion in investments towards Maryland becoming the “Capital of Quantum,” IonQ intends to anchor a state-of-the-art quantum intelligence campus based at the University of Maryland at College Park.

GAITHERSBURG, Md., Jan. 14, 2025 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has entered into an agreement to obtain exclusive commercial rights in the U.S. and Canada to Hikma Pharmaceuticals’ KLOXXADO^® (naloxone HCl) Nasal Spray, an 8 mg naloxone agent that is approved for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.¹ This six-year agreement complements and strengthens Emergent’s mission to protect, enhance, and save lives by helping to reduce opioid overdose deaths —providing compelling product options, combined with a commitment to increasing naloxone access, awareness, and education.

AIN becomes the second selected VCLP to support the next generation of technology innovation

COLUMBIA, Md., (January 15, 2025) — TEDCO, Maryland’s economic engine for technology companies, announces the selection of AIN Ventures as one of the early-stage venture capital fund managers supporting the management and investment of up to $10 million in U.S. Department of Treasury State Small Business Credit Initiative (SSBCI) funding.

“As a mission-driven organization, we are excited to work with early-stage entrepreneurs and TEDCO to strengthen Maryland’s innovation ecosystem and support the successful deployment of valuable SSBCI funding,” said Sherman Williams, co-founder and managing partner of AIN Ventures.

NORTH CHICAGO, Ill. and ROCKVILLE, Md., Jan. 13, 2025 /PRNewswire/ — AbbVie (NYSE: ABBV) and REGENXBIO Inc. (Nasdaq: RGNX) today announced updates to the ABBV-RGX-314 clinical program.

ABBV-RGX-314 in Wet Age-Related Macular Degeneration (wet AMD), Subretinal Delivery
Data from the ATMOSPHERE^® and ASCENT^™ pivotal trials evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in patients with wet AMD are expected in 2026.

ABBV-RGX-314 in Diabetic Retinopathy (DR), Suprachoroidal Delivery
AbbVie and REGENXBIO will plan a Phase 3 clinical program. The clinical program will utilize the in-office SCS Microinjector^® to deliver gene therapy to the suprachoroidal space of the eye.

January 13, 2025 – By Ruxandra Draghia-Akli, MD, PhD, Executive Vice President, Head of R&D and Elaine O’Hara, Executive Vice President, Chief Strategy Officer

As we enter the new year, Novavax is embarking on an ambitious new corporate growth strategy to maximize the impact of our cutting-edge technology. We are focused on forging strategic partnerships for both our early- and late-stage research and development (R&D) assets and our Matrix-M™ adjuvant with the goal of driving vaccine innovation that protects the health of people.

Our Innovative Technology Platform

Novavax’s technology platform combined with our deep vaccine expertise is the fuel for future innovation and partnerships. The unique platform features two key elements:

• Recombinant protein-based nanoparticle: This technology enhances immune recognition by presenting multiple copies of viral antigens on the surface of each nanoparticle. Antigens displayed in this manner tend to lead to greater stimulation of the immune system, resulting in a more efficacious vaccine.^1-3
• Matrix-M™ adjuvant: Our proprietary adjuvant works together with the nanoparticle to induce potent, durable and broad immune responses, with the potential to be antigen-sparing.^4-7 Matrix-M increases both antibody and cell-mediated immune responses to the vaccine, and has demonstrated a favorable tolerability and safety profile in clinical trials across a variety of different antigens.⁷ Matrix-M is used in our authorized COVID-19 vaccine and the R21/Matrix-M malaria vaccine.

Like his fellow Type 1 diabetics, Alec Smith took insulin every day to regulate his blood sugar. Costs to treat his condition topped $1,000 per month, most of that going to insulin, and Alec made the difficult decision to ration his insulin to save money after aging off his mother’s health insurance plan.

Rationing insulin is a delicate process for diabetics. The body’s insulin needs can fluctuate significantly due to changes in diet, exercise, stress, poor sleep, or other medications, and diabetics must constantly monitor their glucose levels even when taking insulin as directed. When a person’s blood sugar gets too high, the body goes into diabetic ketoacidosis, which releases dangerous amounts of acid into the bloodstream and, if left untreated, can result in death — as it unfortunately did for Alec Smith in 2017. His mother, Nicole Smith-Holt, told CBS News, “I think if the price of insulin in 2017 had been $35, Alec would still be alive today.”

ROCKVILLE, Md., Jan. 7, 2025 /PRNewswire/ — Essex Management, an Emmes Group company and a leader in biomedical informatics and health information technology, is pleased to announce the appointment of David Loose as Chief Executive Officer (CEO), effective immediately. David succeeds Kevin Hurley, who has served as CEO since February 2019 and will transition to the role of Executive Advisor.

David Loose joined Essex Management as a partner in February 2009 and has played a pivotal role in the company’s growth. Starting as Vice President for Business Operations and Development, he later served as Chief Business Officer, overseeing critical operations, driving client-focused innovation, and delivering strategic initiatives such as NCI’s Clinical Trials Reporting Program (CTRP). His leadership and dedication to Essex’s mission have been instrumental in building its reputation as a trusted partner in the biomedical and health technology sectors.

“David’s leadership and dedication to Essex’s mission make him the ideal choice to guide the company forward,” said Sastry Chilukuri, CEO of Emmes Group. “His focus on innovation and client success will ensure Essex continues to deliver transformative solutions in biomedical informatics and health IT.”

*NOTE: Solution Summary due: February 14, 2025
 

The Big Question  

What if we could end the rare disease diagnostic odyssey?

The Problem  

Collectively, rare diseases are far from rare — more than 10,000 unique conditions affect over 350 million people worldwide, including one in ten Americans. The lengthy diagnostic “odyssey” endured by patients with a rare disease lasts six years on average but can extend for decades. Diagnostic delays stem from multiple factors, including overlapping symptoms, low disease incidence, and limited specialist expertise. It’s estimated that half of all individuals with a rare disease remain undiagnosed or misdiagnosed, leading to inappropriate care, irreversible disease progression, and rising medical costs.  

BHI is excited to highlight Rachel Rath’s recent LinkedIn Post, where she reflects on her first 90 days as Head of JLABS @ Washington, DC. Rachel, who recently joined the BHI Board of Directors, discusses the Mid-Atlantic’s strengths—including its talent pool, investor activity, and opportunities for deeper collaboration.

We look forward to continuing to work with Rachel and JLABS to drive growth and innovation in the BioHealth Capital Region.

90 Days In: Reflections on an Evolving Life Science Landscape in the Mid-Atlantic

December 30, 2024

The views and opinions expressed in this article are those of the author.

Time flies when you’re having fun! My first 90 days as Head of JLABS @ Washington, DC (JLABS DC) have been both energizing and eye-opening. While I’ve spent nearly 20 years in the DMV (DC-Maryland-Virginia), been part of Johnson & Johnson and the JLABS team for 5 years, and been based at JLABS DC since the site opened, it’s been fulfilling to move from a global role into a role that allows me to deep-dive into the local ecosystem that I call home. The DMV region and broader Mid-Atlantic region boast incredible strengths, but these first few months in the job have underscored the work that remains to unlock the region’s full potential. Here are three reflections as I recognize the strengths of this region and look at how JLABS DC can continue to help spur the region’s trajectory:

DEC 20, ANNAPOLIS, MD — Governor Wes Moore today signed an executive order to strengthen Maryland’s business climate and catalyze more economic growth in the state. The governor signed the order during a visit to the Frederick Hotel and Conference Center project site in Frederick—a public-private development project that is expected to generate $1.5 billion in new private sector spending over the next 25 years, more than 200 jobs, and more than $4 million in state and local tax revenue annually. 

ROCKVILLE, MD, Jan. 6, 2025 /PRNewswire/ — I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today highlighted its strategic outlook for 2025 and a re-prioritization of resources, with a focus on advancing its lead program, givastomig, a CLDN18.2 x 4-1BB bispecific antibody, targeting first-line metastatic gastric cancers, with further potential in other solid tumors.

Italy, December 23, 2024. PQE Group is proud to announce its most recently-received official recognitions: ISO/IEC 27001 and A Women’s Business Enterprise (WBE) Certifications, which provide additional reasons to recognize PQE Group’s extensive capabilities; the ISO/IEC 27001 provides clients assurance that their information management systems are risk-aware and that PQE Group’s solutions can proactively identify and address weaknesses; the WBE Certification ensures that PQE Group has met the stringent eligibility criteria to be classified as a women-owned enterprise.

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.