Leadership team expanded with addition of Chief Corporate Development Officer, Ted Hibben, a 25-year venture-stage business development biotherapeutic industry veteran Total venture funding tops $50M to date

GERMANTOWN, MD / ACCESSWIRE / September 21, 2023 / Seraxis Inc., a cell therapy company developing a pancreatic organoid cure to transform the lives of patients with Type 1 and insulin-requiring Type 2 diabetes, today announced the closing of the second tranche of its inaugural VC round to bring total equity investment in the company to over $50 million. Frazier Life Sciences, Polaris Partners, Eli Lilly and the JDRF T1D Fund participated in the step-up triggered by Seraxis' achieving the completion of preclinical milestones of Seraxis' novel pancreatic organoids, SR-02.

Ronco’s Global Pharmaceutical Experience Will Support the Next Chapter of Emmes’ Growth and Technology Enablement

Rockville, MD, September 20, 2023 – Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Peter Ronco has been named Chief Executive Officer, effective immediately.

Mr. Ronco succeeds Dr. Christine Dingivan, who will serve as a senior advisor to Executive Chairman Sastry Chilukuri, and Emmes’ Board of Directors.

D.C.’s Nanochon LLC is raising $3.5 million to make it through the final leg of its journey to bring a 3D-printed knee cartilage implant to market.

The company has already raised $1.8 million toward the round, according to a Securities and Exchange Commission filing. The company said it plans to use the funds to begin human trials and ultimately get Food and Drug Administration approval for its 3D-printed implant.

Nanochon has raised $5 million since its founding in 2016 to fund the clinical trials needed to bring its medical device to market.

WASHINGTON, Sept. 20, 2023 /PRNewswire/ -- VerImmune Inc. ("VerImmune"), an early-stage biotechnology company specializing in the development of innovative products based on a novel Virus-inspired Particle (ViP™) technology platform, announced today the securing of an additional $3.125 million from follow-on Seed financing and a partnership milestone payment.

The follow-on financing was led by previous investor, Proxima VC, a specialist seed-to-growth healthcare venture capital firm with participation from other previous investors such as Gaingels, Mana Ventures and others. In addition to this financing, a milestone payment from Fosun Pharma USA was triggered by  the successful completion of a process development milestone.

Federal funding fosters development and commercialization of medical devices designed for children

WASHINGTON, D.C., Sept. 19, 2023 (GLOBE NEWSWIRE) -- To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to the Alliance for Pediatric Device Innovation (APDI), a consortium led by Children’s National Hospital. The nonprofit group, which is one of five in the FDA’s Pediatric Device Consortia (PDC) program, will utilize the five-year grant to provide a platform of services, expertise and funding that supports pediatric innovators in bringing medical devices to the market that specifically address the needs of children. New in this cycle, APDI will provide expertise on evidence generation, including the use of real-world evidence (RWE), for pediatric device development.

We're just ONE DAY away from the FREE 9th Annual BioHealth Capital Region Forum, and there's still time to register! Don't miss out on this incredible opportunity to join nearly 500 other registrants on September 19th and 20th. 🗓️

📍 Location: US Pharmacopeia (USP), 12601 Twinbrook Pkwy, Rockville, MD 20850
👔 Attire: Business/Business Casual
🚗 Parking: Paid-parking garage across the street or metered-street parking
🚇 Metro: Twinbrook Metro stop on the Red Line (8-minute walk)

🔬 Why Attend?

• Network with esteemed government officials, academic leaders, and industry executives.
• Explore new avenues for growth within the BioHealth Capital Region.
• Engage in thought-provoking discussions and knowledge sharing.
• Discover investment and partnership opportunities in the vibrant biohealth industry.

📈 The BioHealth Capital Region is a thriving hub of innovation and opportunity, boasting over 2,300 life science companies, 78 federal labs, and renowned academic institutions.

👉 Register now to be a part of this prestigious event and help shape the future of the BioHealth Capital Region!

Visit https://bit.ly/BHCRForum2023 to register now. 

PQE Group is excited to announce the opening of its newest office in Montreal, Quebec, Canada, marking a significant expansion for the company. The expansion aims to provide enhanced services to both existing and potential clients across various regions in Canada. The Greater Montreal area, located along North America's east coast, is renowned for its vibrant life sciences community, featuring prestigious universities, leading hospitals, and innovative life sciences companies. Notably, Quebec serves as a hub for the development and acceleration of artificial intelligence (AI), reflecting its forward-thinking approach to shaping the future. Canada's expertise in AI, characterized by its high-quality research, skilled workforce, and contributions to AI innovation on a global scale, has been a key source of inspiration for PQE Group.

Rockville, Maryland – September 13, 2023 – BioHealth Innovation, Inc. (BHI), a leading regional innovation intermediary, is thrilled to announce the five outstanding finalists for the 8th Annual BioHealth Capital Region Crab Trap competition. The Crab Trap is a competition designed to identify and showcase promising life sciences and biotechnology startups from around the world. These finalists have demonstrated exceptional innovation, vision, and potential to significantly impact the healthcare industry.

ARLINGTON, Va.--(BUSINESS WIRE)--The Accelerate Investor Conference is back for its third year at George Mason University’s Arlington Campus, November 1-2, 2023. Spurring the region’s innovation and entrepreneurship engagement to a new level, the conference will showcase the Virginia, Maryland, and metropolitan DC region as a destination for business development, venture investment, and job creation.

BETHESDA, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced that the Company has received approval from the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1 clinical study of its lead drug candidate GT-02287 in development for GBA1-Parkinson’s disease (GBA1-PD). Dosing in healthy volunteers to assess the safety and pharmacokinetics of GT-02287 is expected to begin in the near term.

GAITHERSBURG, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the completion of dosing (last subject last dose) in its 48-week Phase 2 MOMENTUM trial evaluating the efficacy and safety of pemvidutide in subjects with obesity or overweight. Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH).

One week away from the 9th Annual BioHealth Capital Region Forum (https://bit.ly/BHCRForum2023), a cornerstone event for anyone involved in the biopharma sector. Scheduled for September 19th and 20th at the US Pharmacopeia in Rockville, Maryland, this year's forum promises to be an enriching experience for all attendees. Even better, thanks to the generosity of our sponsors, attendance is entirely free of cost!

A Gathering of Minds

The forum is a unique confluence of thought leaders, industry executives, academic pioneers, and government officials. This year, the keynote addresses promise to be particularly illuminating. Rachel King, the CEO of BIO, will speak on biotechnology's accomplishments and challenges in her talk titled "Biotechnology: What We've Accomplished and the Challenges Before Us." On the other end of the spectrum, Lance Liotta, Co-Director of the Center for Applied Proteomics and Molecular Medicine at George Mason University, will explore the cutting-edge intersection of AI and BioHealth in his keynote, "Hijacking Cellular Communications using AI Tools: A New Frontier in BioHealth."

ROCKVILLE, Md., Sept. 09, 2023 (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, announces the presentation of two posters at Psych Congress 2023 with new data showing improved efficacy in children ages 6 years and older with ADHD when Qelbree is added to a stimulant, as well as in adults with ADHD who undergo long-term treatment with Qelbree.

“While ADHD is recognized as one of the most common psychiatric diagnoses, affecting approximately 16.1 million individuals in the United States, patients are in need of alternative or additional options to stimulants that allow them to manage their symptoms with a safe and tolerable treatment option,” says Jonathan Rubin, Chief Medical Officer and Senior Vice President of Research & Development. “The new Qelbree data presented during Psych Congress 2023 reinforce the efficacy and safety of our novel nonstimulant treatment in addition to existing stimulant therapy in children ages 6 and older with ADHD and in a long-term setting in adults with ADHD.”

BELTSVILLE, Md., Sept. 07, 2023 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the publication of a review article in the online journal Frontiers in Immunology, highlighting the need for targeting tumor collagen in the extracellular matrix (ECM) in the tumor microenvironment to enhance anti-tumor immunity.

“Emerging data on the effects of dysregulated collagen in the ECM show that it modulates accessibility and activity of immune cells within the TME, leading to suboptimal oncology treatment outcomes,” said Solomon Langermann, Ph.D., NextCure’s chief scientific officer. “A key aspect of what we highlighted in this review is that an expanded understanding and cross-fertilization within the fields of tumor matrix biology, cancer biology, and immunology will contribute to improving the efficacy of cancer therapeutics. Importantly, it will enable the development of new classes of therapeutics to address the unmet needs of cancer patients who do not benefit from current therapies. This is a key focus of our ongoing NC410 clinical trial.”

The documentary-style film addresses the urgent global health crisis of antimicrobial resistance, which is causing widespread concern in the scientific and medical fields. The film highlights the dire consequences of this growing issue and showcases the relentless efforts of doctors, scientists, and experts who are working on innovative research and solutions to protect future generations.

https://www.youtube.com/watch?v=5U3k9ruszxI

Your Invitation to apply to a Key Investment Event in Rockville, Maryland Awaits

There's still time if you haven't yet marked your calendar for the 6th Annual BioHealth Capital Region Investment Conference. The one-day event will also be held at the US Pharmacopeia (USP) in Rockville, Maryland, and is free to attend, thanks to our generous sponsors. Applications to attend are due by September 12^th!

A Unique Investment Opportunity: September 21st

The Investment Conference brings together investors and companies seeking funding. With a strong track record of fostering successful financial engagements, this conference is an unparalleled opportunity for those eyeing transformative funding.

Your Invitation to a Pivotal BioHealth Event in Rockville, Maryland Awaits

If you haven't yet marked your calendar for the 9th Annual BioHealth Capital Region Forum, it's not too late. The event will be held at the US Pharmacopeia (USP) in Rockville, Maryland, and is free to attend, thanks to our generous sponsors.

Two Days of In-Person BioHealth Exploration: September 19th and 20th

The Forum is just weeks away and promises an in-person experience under the theme "Global Breakthroughs for a Healthier Future." This cornerstone event offers industry experts, academic trailblazers, and government representatives a unique opportunity to reconnect in this “Top 3” BioPharma cluster.

The horseshoe crab has endured for over 450 million years.In this episode we talk with three experts about how this animal’s unique blue blood has become essential to modern medicine. We also talk about why horseshoe crab populations are dwindling, and what biotech is doing to address the shortfall.

Click here to listen.

GSK has announced it is investing over £270m to build a new vaccine manufacturing facility at its Wavre campus in Belgium.

The investment follows the launch of the company’s new respiratory syncytial virus (RSV) vaccine, Arexvy.

Designed to increase the efficiency of manufacturing processes and reduce environmental impact, the new unit will handle freeze-dried vaccines, including Arexvy, as well as the company’s fast-growing shingles vaccine, Shingrix, and its malaria vaccine, Mosquirix.

US-based biotech company VLP Therapeutics, Inc. (VLPT) and its Tokyo-based group company VLP Therapeutics Japan, Inc. (VLPT Japan) together announced on September 5 the second closing of its financing round, which secured investments from two existing investors: MUFG Bank, Ltd., and Miyako Kyoto University Innovation II L.P., as well as two new investors: FFG Venture Business Partners Co., Ltd. and toberu Fund run by Phoenixi Co., Ltd.

With this funding the VLPT group plans to: 1) bolster its vaccine research and development underway in the US for cancer treatment and infectious disease prevention, such as malaria and dengue; and 2) establish a manufacturing facility, which is expected to begin operation in 2024–2025 and will enable VLPT Japan to produce investigational vaccines in-house in Fukuoka, Japan.

ROCKVILLE, MD, Sept. 05, 2023 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that its partner, Gilead Sciences, Inc. (NASDAQ: GILD), nominated the first of two research programs, leveraging MacroGenics’ DART® and TRIDENT® platforms for generating bispecific antibodies. This nomination grants Gilead an exclusive option, upon achievement of a pre-defined preclinical milestone, to license worldwide rights to the research program.

Join us for an insightful episode of BioTalk as host Rich Bendis welcomes back Rachel King, the visionary CEO of the Biotechnology Innovation Organization (BIO), bringing with her a remarkable journey spanning roles as an entrepreneur, board member, and advocate for the biotech industry.

In this engaging installment, Rachel offers a glimpse into her evolution from consulting to industry, including her role as co-founder and former CEO of GlycoMimetics, Inc. (GMI). Discover the essence of BIO, its mission, and the global perspective it brings to the biotech landscape. Delve into Rachel's advocacy role and the critical issues facing the industry today, including pricing, congressional relations, and investment challenges. Gain insights into the state of the biotech industry and Rachel's projections for both the near and long term.

Listen as we unravel the dynamic journey of Rachel King, a trailblazing leader in biotechnology, and gain a comprehensive perspective on the industry's present and future. Available now on all major podcasting platforms.

Listen now via your favorite podcasting platform:

• Apple: https://apple.co/3Eotykt
• Google: https://bit.ly/3Pb4EKm
• Spotify: https://spoti.fi/45wRwWG
• Amazon Music: https://amzn.to/483quYP
• TuneIn: https://bit.ly/45NbRXA
• YouTube Audio: https://bit.ly/3r4i3eT

THOUSAND OAKS, Calif. and DUBLIN, Sept. 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen's acquisition of Horizon.

As a result of the consent order agreement, Amgen and Horizon expect that the parties will jointly file stipulated proposed orders to dismiss the preliminary injunction motion and dissolve the temporary restraining order (TRO) in the U.S. District Court for the Northern District of Illinois, and that Amgen and Horizon will quickly seek the final approvals required under Irish law to close the acquisition.

GAITHERSBURG, Md., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions Inc. (NYSE: EBS) announced NARCAN^® Naloxone HCl Nasal Spray 4 mg will be available on shelves nationwide and online beginning in September. Over-the-counter (OTC) access to NARCAN^® Nasal Spray offers more people the ability to respond in an opioid emergency, helping to save lives and keep loved ones and communities safe. Expanding access and awareness is critical given the staggering toll of the epidemic mainly driven by synthetic opioids, like fentanyl.¹ Last year, approximately every seven minutes one life was lost due to an opioid overdose, and today it is the leading cause of accidental death in the U.S.^2,3 The average response time for emergency services to arrive is approximately 10 minutes.⁴ Having NARCAN^® Nasal Spray in a first-aid kit, or carrying it on the go in case of an opioid emergency, can make a difference and help reverse the effects of opioids while waiting for emergency personnel to arrive.

Los Angeles, CA; September - CellKey, a leading provider of innovative bioanalytical solutions, is thrilled to announce the signing of a Memorandum of Understanding (MOU) with Emerald Cloud Lab (ECL), a pioneer in cloud-based laboratory facilities, to collaborate on the development of a cutting-edge glycoprotein analysis platform. This strategic partnership aims to revolutionize glycosylation studies, essential for diagnosing and treating cancer and various other diseases, as evidenced by the groundbreaking work of the recent Nobel laureate in Chemistry at Stanford University.

The Frederick National Laboratory Advanced Technology Research Facility in Frederick, MD, is set to host the 2023 Technology Showcase on September 6, 2023. This annual event serves as a platform for potential industry partners to engage with the National Cancer Institute (NCI) and Frederick National Laboratory (FNL).

Registration and Attendance

Interested parties can register to attend the showcase either in person or online. Each mode of attendance has its own unique registration link, offering flexibility for participants.

What to Expect

The Technology Showcase is a free hybrid event featuring a variety of activities and opportunities:

• Inventor Highlights: NCI and FNL inventors will present technologies ripe for commercialization and collaboration.

• Programmatic Insights: Leaders from NCI and FNL will share avenues for potential collaboration.

• Partnership Perspectives: The event will provide insights into what partnering with NCI and FNL entails, including viewpoints from companies that have successfully collaborated.

• Panel Sessions: These will feature success stories and topics relevant to the commercialization of biomedical technology.

• Lightning Pitch Competition and Poster Session: These segments will spotlight NIH technologies available for co-development or licensing, presented by the NCI Technology Transfer Ambassadors Program.

Maryland-based veteran-owned biotech company is working to transform mental health care

COLUMBIA, Md. (August 28, 2023) – Charles Cathlin, CEO of Polaris Genomics (TEDCO Portfolio company)TEDCO, Maryland’s economic engine for technology companies, announced its Venture Funds invested $500,000 State Small Business Credit Initiative (SSBCI) funds in Polaris Genomics, a Maryland-based biotech company.

It’s been a tough year for biotech, so how about a little good news? In between all the layoffs, restructurings and last-ditch strategic option hunting, we wanted to take a moment to shine a spotlight on 15 innovative and truly fierce biotechs.

That didn't surprise us, because everyone we talk to in the Fierce Biotech universe tells us that science doesn't stop for the markets. Financing might be a little tough right now, but innovation, breakthroughs and discoveries are all still being made. 

The latest crop of Fierce 15 honorees consists of companies pushing the envelope not only in the lab, in the clinic or on the conference circuit: They are also defining what it means to be a modern biotech company, with modalities ranging from radiopharmaceuticals to cell therapy. Indications as diverse as oncology, neurodegenerative disorders, Pompe disease and even pregnancy complications made the list this year.

Danaher’s wide-ranging offerings for the life sciences sector will get broader and deeper with the $5.7 billion acquisition of Abcam, a company that makes reagents and tools used in scientific research, drug discovery, and diagnostics.

According to deal terms announced Monday, Washington, D.C.-based Danaher agreed to pay $24 cash for each Abcam share, which is a modest 2.7% premium to that company’s $23.36 closing stock price on Friday. However, shares had already spiked sharply in June after Abcam announced it would pursue a strategy to increase shareholder value as it fended off attempts by company’s founder and former CEO to wrest control of the business. Abcam also said in June it would explore strategic alternatives, including the potential sale of the company. Abcam said Monday that its process engaged with more than 30 entities, a list that narrowed to 20 potential acquirers before leading to the Danaher acquisition agreement.

WASHINGTON, Aug. 28, 2023 /PRNewswire/ -- The Lupus Foundation of America and Lupus Canada are pleased to announce Joan Wither, MD, PhD, FRCPC has been awarded the 2023 Lupus Canada Catalyst Award for her study "Interferon and Prediction of Treatment Responses in Lupus Nephritis," focused on interferon (IFN)-induced genes (an inflammatory marker) to predict treatment response in lupus nephritis with a new technique that could be incorporated into routine analysis of kidney biopsies.