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.

BETHESDA, Md. & WEST JEFFERSON, Ohio--(BUSINESS WIRE)--Vitrian, the leading end-to-end provider of investment capital and capacity building services for biomanufacturing, announced today that it closed a $50 million investment, with ability to scale to $65 million, into AmplifyBio’s Manufacturing Enablement Center (AMEC) in New Albany, Ohio as a first step of a larger commitment to support biomanufacturing in Central Ohio. AmplifyBio is a leading advanced therapy CRO and CDMO offering a full range of drug development and manufacturing services.

Novavax Inc. (NASDAQ: NVAX) has tapped AstraZeneca and Pfizer alum Åsa Manelius to oversee operations at the Swedish lab where it manufactures a key vaccine ingredient that's expected to help drive the Gaithersburg company's growth.

The company said this week it has named Manelius as its new managing director of the Novavax AB site in Uppsala, Sweden — where it makes Matrix-M, the adjuvant for its Covid-19 vaccine and other candidates it’s developing. She will assume the post in Feburary.

Manelius succeeds Magnus Savenhed, a nearly 20-year Novavax executive who held that position since 2018. He became CEO of Swedish biotech TdB Labs AB in September.

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10 groundbreaking startups to pitch at Richmond's Main Street Station on November 20, 2024

RICHMOND, Va., Nov. 4, 2024 /PRNewswire/ -- Activation Capital, an innovation ecosystem development organization, is thrilled to announce the Frontier BioHealth Showcase, an event highlighting the achievements of 10 fast-growing life science startups that have completed the inaugural Frontier BioHealth program. Taking place on November 20 at Main Street Station in downtown Richmond, VA, the event kicks off with networking and beverages in the Head House at 4 pm, followed by the Showcase in the Concourse Room at 5 pm, where each startup will deliver a five-minute pitch to an audience of mentors, investors, and community leaders.

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.[1]

In this episode of BioTalk, Rich Bendis sits down with Rachel Rath, the Head of JLABS @ Washington, DC, to discuss her journey and insights on building a thriving ecosystem for life sciences innovation. Rachel shares her academic and professional background, from roles at PCORI and BARDA Blue Knight to leading JLABS @ Washington, DC. She offers an in-depth look at JLABS’ national and international footprint, and the significant partnerships with organizations like Children’s National, Virginia Tech, and BARDA that strengthen the innovation landscape across the mid-Atlantic.

Tune in as Rachel shares the current priorities at JLABS, highlighting the diversity of its tenant portfolio, which spans MedTech, Pharma, and Integrated Healthcare Solutions. She also discusses how JLABS companies benefit from the support and resources available through Johnson & Johnson, including access to valuable connections, mentorship, and funding opportunities via JJDC.

Listen now via your favorite podcasting platform:

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TuneIn: https://bit.ly/4ecryv7

FREDERICK, MARYLAND, November 4, 2024: BioFactura, Inc. recently announced contract option activations totaling $7.8 million by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services, as part of BioFactura’s prime contract valued at up to $78 million for the advanced development of a Smallpox Biodefense Therapeutic. This monoclonal antibody cocktail therapeutic has the potential to augment current medical countermeasures, guard against potential resistance of the Smallpox virus, and fulfill an unmet need in our nation’s biothreat preparedness.

Nanochon’s mission is to develop a new approach to treat cartilage replacement and repair so that the hundreds of thousands of young, active patients with knee damage can return to their lifestyles without having to undergo costly and invasive short-term fixes. Founded in 2016, their technology is a minimally-invasive early intervention that could help avert the need for total knee replacement. Nanochon’s Chondrograft device is a sturdy medical advancement that is one part orthopedic load-bearing implant, one part tissue growth scaffold, and completely revolutionary. Their implant replaces lost or damaged cartilage and encourages new growth using innovative nanomaterial and 3-D printed designs. This technology has the potential to provide a more successful, faster, longer-lasting, and more affordable solution to joint disease and injury.

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.

Michelle Tarver, the new leader of the Food and Drug Administration’s medical device center, faces significant challenges ahead. 

Tarver is taking over as director of the Center for Devices and Radiological Health as the regulator grapples with questions around artificial intelligence in medical devices, racial bias in pulse oximeters, concerns about the recall process after Philips pulled millions of respiratory machines, and scrutiny of its former leader’s potential conflicts of interest. 

COLUMBIA, Md., (October 31, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Seed Funds investment in NeuroIntact. 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.

“Elevated pressure in the brain as a result of a cerebral edema can be not only damaging, but also life-threatening without proper treatment,” said Bryan Nicholson, president of NeuroIntact. “That’s why we’re working on creating a solution and thanks to this recent investment from TEDCO, we can continue progressing in our research and development efforts.”

Germantown, Maryland, and Venlo, the Netherlands, Oct. 29, 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 Respiratory Panel Mini test for clinical use. It is the third test to receive FDA clearance for use with QIAstat-Dx systems in 2024.

The QIAstat-Dx Respiratory Panel Mini is designed to support clinical decision making in diagnosing upper respiratory infections in outpatient settings and covers five common viral causes of illness: influenza A, influenza B, human rhinovirus, respiratory syncytial virus (RSV) and SARS-CoV-2. The panel leverages QIAstat-Dx’s ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of co-infections, and are instantly viewable on the instrument touchscreen with no additional software required.

ROCKVILLE, Md., October 29, 2024--(BUSINESS WIRE)--GlycoMimetics, Inc. (NASDAQ: GLYC) announced today it has entered into an acquisition agreement with Crescent Biopharma, Inc. ("Crescent"), a privately held biotechnology company advancing a pipeline of oncology therapeutics designed to treat solid tumors. Upon completion of the transaction, the Company plans to operate under the name Crescent Biopharma, Inc.

In support of the acquisition, a syndicate of investors led by Fairmount, Venrock Healthcare Capital Partners, BVF Partners, and a large investment management firm, with participation from Paradigm BioCapital, RTW Investments, Blackstone Multi-Asset Investing, Frazier Life Sciences, Commodore Capital, Perceptive Advisers, Deep Track Capital, Boxer Capital Management, Soleus, Logos Capital, Driehaus Capital Management, Braidwell LP, and Wellington Management, has committed $200 million to purchase GlycoMimetics common stock and GlycoMimetics pre-funded warrants to purchase its common stock. The transaction is expected to close in the second quarter of 2025. The financing is expected to close immediately following the completion of the transaction. The Company’s cash balance at closing is anticipated to fund operations through 2027, including advancement of the Company’s lead program CR-001, a tetravalent PD-1 x VEGF bispecific antibody, through preliminary proof of concept clinical data in solid tumor patients expected in the second half of 2026.

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.

At Washington, D.C.’s recent Start-Up & Technology Week on October 25th, BioHealth Innovation’s Executive-in-Residence, Luis Gutierrez, led a pivotal panel as part of the life science track sponsored by J-Labs.   It was titled “The Quest for Resources: Unlocking Opportunities for Life Sciences Start-Ups.” Panelists included Ashim Subedee (BARDA DRIVe), Amy Adams (George Mason University), Jack Miner (TEDCO), Sara Adams (DMPED), and Deborah Hemingway (Ecphora Capital), all sharing insights on resource maximization in the BioHealth Capital Region (BHCR).

The invited teams highlight the broad interest in the NSF Engines program and show great promise in building regional ecosystems that will accelerate breakthrough technologies, leading to economic development.

The U.S. National Science Foundation Regional Innovation Engines (NSF Engines) program announced that 71 teams spanning nearly every state and territory in the nation are advancing to the next stage of the second-ever competition. The program is charting a new frontier for American innovation pursuant to the bipartisan "CHIPS and Science Act of 2022." The teams selected to submit full proposals stand to build upon an inaugural cohort of regions nationwide that are bringing technology-driven economic and workforce development to all parts of the United States. Explore the interactive map.  

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.

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.

For Immediate Release: Wednesday, October 23, 2024 - Montgomery County Executive Marc Elrich today announced the launch of a $10 million Job Creation Fund, a new initiative aimed at driving economic growth and encouraging job creation in the County’s key industries. The program, established by a special appropriation through County Council Resolution 20-491, led by Council President Andrew Friedson, will provide financial incentives of up to $500,000 for businesses that create high-paying jobs in sectors such as advanced technology, life sciences, cybersecurity, hospitality and quantum computing.

Eligible companies can receive $10,000 for each new job created, with increased incentives for businesses located in disadvantaged areas as defined by the County’s Community Equity Index. The fund is designed to build on Montgomery County’s reputation as a hub for innovation and economic opportunity, while also supporting job creation that strengthens the local workforce.

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.  

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.

WASHINGTON, D.C., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Pain assessment in medicine often relies on imprecise visual rating scales featuring smiling or crying faces, frustrating patients and physicians alike. Children’s National Hospital researchers aim to change this with a new device designed to precisely measure pain, backed by an $8-million award from the Advanced Research Projects Agency for Health (ARPA-H) Sprint for Women’s Health. 
  

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.

SILVER SPRING, Md. & JACKSONVILLE, Fla.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, and its subsidiary Lung Bioengineering Inc. (LBE) announced that the 500^th lung transplant utilizing LBE’s centralized ex vivo lung perfusion (EVLP) service was completed last month. These 500 transplants were the result of evaluating over 800 donated lungs using centralized EVLP since 2014.

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.

A well-oiled collaboration

It takes a village to plan and manage a forum. The BioHealth Capital Region (BHCR) Conference planning committee collaborated with sponsors including TEDCO and event management from Taylor Made Experience to ensure an organized, engaging event.

TEDCO’s chief investment officer Jack Miner praised the BioHealth region and forum, noting “This region is probably the most functional in terms of sharing resources, not diluting each other’s efforts…the entrepreneurs really benefit a lot from the collaboration that’s been created in this region, and that’s really unique.”

Richard Bendis, founder, president, and CEO of BHI agreed, stating “We’re proud to have TEDCO as a collaborator who is funding a lot of the early-stage life science companies in the state of Maryland that actually are participants in this event.”

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).

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.

Listen now on your favorite podcast platform:

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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.