VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced it received comments from the U.S. Food and Drug Administration (FDA) on the confirmatory Registration Study’s Statistical Analysis Plan (SAP) submitted in December of 2024 for the study of Multikine* (Leukocyte Interleukin, Injection) as a neoadjuvant in the treatment of newly diagnosed previously untreated locally advanced head and neck cancer. The FDA stated no response to their comments were required from CEL-SCI and that the agency presently has no comments on the confirmatory study protocol, which was submitted for FDA review contemporaneously with the SAP in December 2024.

CEL-SCI’s 73,000 square foot Multikine manufacturing facility presently has the capacity to produce over 12,000 Multikine treatments per year. Over $200 million has been invested in the facility and the development and validation of its proprietary biologic manufacturing processes.

BETHESDA, Md., March 14, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the dosing of the first participant with Parkinson’s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company’s lead allosteric small molecule in development for the treatment of PD with or without a GBA1 mutation.

“Initiation of dosing in our Phase 1b clinical trial represents an important step in the clinical development of GT-02287 and in Gain’s mission to deliver a disease-modifying therapy to people with Parkinson’s disease. We look forward to continued enrollment and anticipate an interim analysis from the towards the end of 2Q 2025,” said Gene Mack, President and CEO of Gain Therapeutics.

By Sara Gilgore – Staff Reporter, Washington Business Journal -Mar 12, 2025 - Gaithersburg’s Shuttle Pharmaceuticals Holdings Inc. (NASDAQ: SHPH) has brought in a new executive to spearhead the biotech’s business activity, freeing up its longtime leader, a cancer doctor and physician administrator, to focus on research and development.

The company’s co-founder and chief executive, Dr. Anatoly Dritschilo, is now one of two co-CEOs, and will oversee the clinical trials and scientific work required to get its lead candidate for an aggressive brain cancer to patients. And Christopher Cooper, a former oil and gas industry exec who also leads a telecommunications company, has joined Shuttle as the other co-CEO on an interim basis. He will focus on the business activity and raising money through the capital markets, the firm said Wednesday.

HONOLULU, HI, Mar. 12, 2025 – Motivity, a leading provider of clinical SaaS solutions for Applied Behavior Analysis (ABA) providers who treat children with autism, today announced a $27 million investment from Five Elms Capital, a leading software investment firm. The funding will enable Motivity to accelerate product innovation, expand its team, and strengthen support for ABA providers worldwide.

Since its founding in 2012, Motivity’s mission has been to empower ABA clinicians with cutting-edge technology that strengthens clinical effectiveness and improves outcomes. To date, the company has secured $11 million in Small Business Innovative Research (SBIR) grants used to develop next-generation solutions, including AI-driven workflows, analytics for clinical decision support, and caregiver engagement tools. Today, Motivity serves over 550 organizations across seven countries, enhancing the delivery of high-quality, data-driven care.

GAITHERSBURG, Md. and BASEL, Switzerland, March 12, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS), a leading public health company that delivers protective and life-saving solutions to communities across the world, and Rocketvax Ltd, one of Switzerland’s next-generation vaccine companies and a member of the Swiss Rockets Ltd family of companies, today announced entry into an agreement for Emergent’s strategic financial investment into Swiss Rockets Ltd, the parent company of Rocketvax Ltd, to support research, infrastructure development, and the expansion of Swiss Rockets’ innovative biotechnology portfolio. This endeavor underscores Emergent’s commitment to supporting Swiss Rockets’ broader mission of pioneering breakthrough medical technologies.

Rockville, Md. (March 11, 2025) – Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation allogeneic, platelet-derived, cellular therapeutics, is excited to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CLPH-511 (Frozen Activated Platelets) Injectable Suspension for the treatment of acute hemorrhage as an alternative to conventional platelets when not available or in short supply.  

COLLEGE PARK, Md.--(BUSINESS WIRE)-- IonQ, Inc. (NYSE: IONQ), a leader in the quantum computing and quantum networking industries, today announced that under its “at-the-market” equity offering program (the “ATM Program”) it has sold a total of 16,038,460 shares of its common stock for an aggregate amount of approximately $372.6 million, netting aggregate proceeds of approximately $360 million.

The Company has determined that it has raised a sufficient amount under the program to meet its currently anticipated capital needs. The Company also determined that given overall recent market disruptions, the trading prices for its shares, and the overhang from having an ATM Program in effect, the ATM Program should be terminated. The Company has therefore terminated the ATM Program today and a prospectus supplement will be filed under Rule 424(c) reflecting such termination.

BANGALORE, India, March 10, 2025 /PRNewswire/ -- Syngene International Limited ('Syngene'), a global contract research, development, and manufacturing organization (CRDMO), today announced the acquisition of its first biologics site in the USA – fitted with multiple monoclonal antibody (mAbs) manufacturing lines.

The state-of-the-art biologics facility, acquired by Syngene USA Inc., a wholly owned subsidiary of Syngene, from Emergent Manufacturing Operations Baltimore, LLC (a subsidiary of Emergent BioSolutions Inc.), will expand Syngene's growing global biologics footprint to better serve its customers across both human and animal health market segments. The new site will increase Syngene's total single-use bioreactor capacity to 50,000L for large molecule discovery, development, and manufacturing services. Additionally, it will provide Syngene's customers with continuity of supply from its four development and manufacturing facilities located in India and North America, offering services ranging from cell line development, process optimization and both clinical and commercial supply.

The life sciences industry is constantly evolving, influenced by new technologies, regulatory changes, and market dynamics. To help professionals stay informed, the MCCC Life Science Program is hosting MCCC Trends in Life Science on Wednesday, March 12, 2025, at MCCC, 51 Monroe Street, Suite 1800, Rockville, MD. This must-attend event will provide valuable insights into the forces shaping the future of life sciences.

Why Attend?

✔️ Stay ahead with expert insights on emerging industry trends
✔️ Learn how to navigate complex regulatory and tax landscapes
✔️ Build connections with key stakeholders in the life sciences ecosystem

GAITHERSBURG, M.D., March 06, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company, today announced that it will host a virtual R&D Day on Thursday, March 13, 2025 beginning at 12:00 pm Eastern Time.

The event will include presentations from renowned Key Opinion Leaders (KOLs) in obesity, MASH and each of the two additional indications, covering the scientific rationale for pemvidutide in each indication, clinical data generated to-date and plans for the continued development of pemvidutide, including the upcoming topline data readout from IMPACT, the Company’s Phase 2b trial in MASH, which is expected in the second quarter of 2025.

GERMANTOWN, Md. & VENLO, Netherlands--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, further strengthening its syndromic testing portfolio in the United States.

This marks QIAGEN’s second FDA clearance of a QIAstat-Dx panel in 2025, and builds on the authorization of five panels for use on the QIAstat-Dx system within the last 10 months.

QIAGEN has now received regulatory clearances for three mini panels for detection of respiratory and gastrointestinal conditions, with these panels designed for outpatient use to aid fast and informed treatment decisions.

ROCKVILLE, Md. and SUZHOU, China, March 05, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company engaged in discovering, developing, and commercializing therapies to address global unmet medical needs primarily for hematological malignancies, today announced that its drug, olverembatinib, has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), for combination with low-intensity chemotherapy for the first-line treatment of newly-diagnosed patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

By Sara Gilgore – Staff Reporter, Washington Business Journal -Mar 5, 2025 - A New York health care technology company that recently adopted a new name has also found a new home — in Greater Washington.

Claritev Corp. (NYSE: CTEV), a 45-year-old firm previously known as MultiPlan Corp. (NYSE: MPLN), has moved its corporate headquarters to McLean, according to filings with the Securities and Exchange Commission.

The building at 7900 Tysons One Place, known as Tysons Tower, also counts Intelsat Corp. and Deloitte LLP as tenants.

Claritev’s move to McLean represents somewhat of a fresh start for the business, which last year lost $1.6 billion and was hit with several lawsuits from the American Medical Association and several health systems alleging it colluded with insurers to underpay doctors.

Life sciences company developing a cost-effective production process for cancer immunotherapies

COLUMBIA, Md., (March 5, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 Life Sciences Investment Fund (LSIF) investment in Irazú Oncology. The LSIF is nestled under the umbrella of TEDCO’s Seed Funds and is dedicated to supporting qualifying startups with an FDA pathway.

"At Irazú Oncology, we are committed to developing cancer therapies that are both more versatile and accessible to patients worldwide," said Jeff Strovel, CEO of Irazú Oncology. "TEDCO's support has been instrumental in advancing our innovative platform. Their MII program and strategic investments have enabled us to accelerate our research and development efforts, bringing us closer to our mission of delivering more effective cancer treatment options. I would encourage researchers and emerging biotech companies to explore the remarkable opportunities that TEDCO offers to help translate promising science into life-changing therapies."

USP publishes Vulnerable Medicines List to inform efforts to reduce risk and increase supply chain reliability for patients 

Rockville, MD – The U.S. Pharmacopeia (USP) today published the “2024-2025 Vulnerable Medicines List for the United States: A data-based approach to identify risks and enable interventions to increase reliability of supply”. This list complements other resources, such as FDA’s essential medicines list. 

Using the USP Medicine Supply Map and other resources, USP identified 100 vulnerable medicines – 49 used to manage chronic conditions and 51 for acute care – to encourage dialogue and action to bolster medicines supply chain resilience. A public list of medicines vulnerable to shortage can help stakeholders work more effectively to make the medicine supply chain more reliable for patients. 

ROCKVILLE, Md., March 4, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the closing of its previously announced strategic partnership with Nippon Shinyaku.

Under the terms of the agreement, REGENXBIO and Nippon Shinyaku will develop and commercialize RGX-121 (clemidsogene lanparvovec) for Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome and RGX-111 for Mucopolysaccharidosis I (MPS I), also known as Hurler syndrome in the United States and Asia.

POTOMAC, MD / ACCESS Newswire / March 4, 2025 / IGC Pharma, Inc. ("IGC" or the "Company") (NYSE American:IGC) today announced an advancement in its Artificial Intelligence ("AI") platform with the development of a new AI-driven model designed to improve the diagnosis of Alzheimer's disease (AD) and other causes of dementia. With Alzheimer's accounting for approximately 60-80% of all dementia cases, alongside other conditions such as vascular disease, Lewy body disease, and frontotemporal degeneration, accurate diagnosis is critical to ensuring the right treatment strategy.

Dementia affects over 55 million people worldwide, causing progressive cognitive decline, memory loss, and behavioral changes. Despite its widespread impact, current diagnostic methods often rely on invasive procedures, expensive imaging, and subjective clinical assessments, leading to high rates of misdiagnosis and delayed treatment.

GAITHERSBURG, Md.--(BUSINESS WIRE)--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, announced today an indication expansion for its industry leading genetic testing to now include cerebral palsy (CP). In conjunction with Cerebral Palsy Awareness Month, the company is expanding its strategy of focusing on pediatric rare disease patients to now include offering testing for pediatric patients with CP. This strategic indication expansion underscores the importance of improving access to exome and genome testing for patients with CP to shorten the diagnostic odyssey and accelerate the path to treatment.

By Kevin Davies, PhD - March 3, 2025 - After an illustrious career including 12 years as director of the National Institutes of Health (NIH) and leading the international Human Genome Project (HGP) consortium, Francis Collins, MD, PhD, announced his sudden resignation from the NIH over the weekend.

He joined the NIH in 1993, a guitar-playing physician-scientist (and born-again Christian) who could not resist the challenge of helming the sequencing of the human genome. “How could I walk away from the chance to lead such an historic enterprise?” he wrote.

Collins served three presidents during his 12 years as NIH director, including the onset of the COVID-19 pandemic. He also served as chief White House science advisor to President Biden, accepting the position following the sudden resignation of his HGP ally, Eric Lander, PhD. Throughout his tenure, Collins maintained his research lab at the NHGRI, publishing a paper in GEN’s sister peer-reviewed journal, The CRISPR Journal, led by Lori Bonnycastle, PhD, 12 months ago on the generation of induced pluripotent stem cell lines using prime editing.

Since I have been raising and deploying a venture fund focused on addressing health of women lately, I have had numerous occasions to be in rooms where the discussion ended up at “it’s really hard to raise venture capital for women’s health companies.”  The whole discussion of venture funding for women’s health (and by women’s health, I do NOT mean things that are limited only to conditions faced ONLY by women) is getting a lot of play lately as many organizations have, thankfully, risen to the occasion of developing funds to drive this market forward.  Granted, most of these funds remain on the small side and there are many entrepreneurs competing for these fresh new greenbacks, but hey, progress is progress.

By Annabel Baldy - In November’s What’s the Buzz?! LinkedIn Live session, Chris Frew, CEO of BioBuzz and Tammi Thomas, Chief Development & Marketing Officer, TEDCO explored TEDCO’s profound influence on Maryland’s entrepreneurial landscape. For over 26 years, TEDCO has played a pivotal role in fostering the growth of technology and life science startups, driving innovation, creating jobs, and strengthening the regional economy.

The TEDCO Entrepreneur Expo: Connecting Entrepreneurs to Resources
A key highlight of the discussion was the TEDCO Entrepreneur Expo, held in December in Baltimore. As a premier networking event, the Expo provides entrepreneurs with access to critical resources, direct connections with industry leaders, and insights into funding opportunities. Events like these are essential for cultivating an environment where startups can thrive. TEDCO’s funding programs not only inject capital into the economy but also fuel job creation and technological advancements.

By Alex Philippidis - February 26, 2025 - The FDA has granted Priority Review to Precigen’s Biologics License Application (BLA) for its lead candidate PRGN-2012, the company said—a step forward for a gene therapy that, if approved, would be the first treatment indicated for adults with the rare disease of recurrent respiratory papillomatosis (RRP).

The FDA also set an August 27 target date for deciding on Precigen’s BLA under the Prescription Drug User Fee Act (PDUFA). PRGN-2012—which Precigen has begun to call by its generic name of zopapogene imadenovec—is a gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11.

Protenus, a leading healthcare compliance analytics platform that serves over 200 healthcare organizations, was acquired in January 2025 by Bluesight, a prominent provider of inventory management, procurement, and compliance solutions for health systems and hospital pharmacies. This acquisition marks a significant milestone in Protenus’ journey, which began nearly 12 years ago at Johns Hopkins University.

The story of Protenus began with the initiation of DreamIt Health Baltimore (BHI was also a DreamIt Partner), a former accelerator the university helped sponsor, which was organized by its parent company, DreamIt Ventures. The program received about 100 applications, and 10 teams were selected for the first cohort. Among them were medical students Nick Culbertson and Robert Lord. Initially, they set out to innovate in the digital health space without a specific product in mind however, their journey changed after they connected with Peter Greene, the Chief Medical Information Officer of Johns Hopkins Medicine.

BALTIMORE--(BUSINESS WIRE)--TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, today announced the initiation of a fully funded Phase 2b clinical trial evaluating oral TNF-alpha (TNF-α) inhibitor drug candidate isomyosamine as a treatment for chronic inflammation associated with muscle loss (frailty or sarcopenia) in patients who have undergone hip or femur fracture repair surgery.

COLUMBIA, Md., (February 25, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Venture Funds investment in Pathotrak. TEDCO’s evergreen Venture Funds are dedicated to funding and growing the next generation of early-stage technology and life sciences businesses in Maryland. Through this fund, companies are offered an experienced team that is focused on supporting the entrepreneurial journey.

“Ensuring food safety is a growing challenge, and current testing methods are often slow and costly for producers,” said Javier Atencia, CEO of Pathotrak. “With TEDCO’s continued support, we are advancing our technology in an effort to shorten the time required for pathogen detection, empowering manufacturers with what we hope are faster, more reliable solutions.”

By Benjamin Mueller -The Trump administration stormed into office, loudly firing workers and closing diversity programs. But behind the scenes, it has also brought biomedical research to the brink of crisis by holding up much of the $47 billion the United States spends on the field every year.

The world’s leading medical labs can be found in the United States, and they rely on grants from the National Institutes of Health. The agency has stopped vetting future studies on cancer, Alzheimer’s, heart disease and other ailments. Trump aides have said they just need time to review spending their predecessors had promised, but it’s unclear what they’re looking for at the N.I.H. or when scholars can expect to start receiving money again.

In today’s newsletter, I’ll walk you through what happened — and why it matters.

On April 1, 2025, Georgetown University’s Office of Technology Commercialization, in partnership with the Georgetown Entrepreneurship Initiative, will host the first-ever Georgetown Research and Innovation Showcase. This half-day event will bring together researchers, entrepreneurs, investors, and industry leaders to highlight groundbreaking discoveries and explore commercialization opportunities.

Attendees can expect engaging research presentations, an industry panel discussion, and a fast-paced Venture Fair, where selected faculty, student, and alumni-led startups will pitch their disruptive technologies to an audience of venture capitalists, angel investors, and corporate innovation teams.

The event will culminate in a networking reception, offering a unique opportunity for collaboration and funding discussions between the Georgetown community and key industry players. Whether you’re an innovator, investor, or looking to connect with cutting-edge ventures, this is an event you won’t want to miss.

📅 Date: April 1, 2025
🕜 Time: 1:30 PM – 6:30 PM ET
📍 Location: Georgetown University

Don’t miss your chance to be part of this exciting showcase of innovation and entrepreneurship!

https://otc.georgetown.edu/newsevents/research-and-innovation-showcase-2025/

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced it is in the final stages for the launch of its 212-patient Confirmatory Registration Study for Multikine* (Leukocyte Interleukin, Injection) in newly diagnosed locally advanced head and neck cancer patients. This final Registration Study is specifically designed to confirm the statistically significant efficacy and safety results from CEL-SCI’s previously completed randomized controlled Phase 3 trial.

GERMANTOWN, Md.--(BUSINESS WIRE)--Amarex today announced its work on behalf of Britecyte has resulted in a “safe to proceed” status by the United States Food and Drug Administration (FDA) for its Adipose Tissue Allograft (BRC-OA).

BALTIMORE, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Elixirgen Therapeutics, Inc., a clinical-stage biotechnology company focused on treating rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to EXG-34217, a gene therapy for treatment of Telomere Biology Disorders (TBDs). EXG-34217 is currently being studied in an ongoing Phase 1/2 trial (NCT04211714) for the treatment of patients with TBDs with bone marrow failure. Enrollment is currently open for participants aged 12 and older, regardless of gender or ethnicity.

The FDA recently granted EXG-34217 Rare Pediatric Disease Designation (RPDD) and Regenerative Medicine Advanced Therapy (RMAT) Designation.

ANNAPOLIS, Md., Feb. 19, 2025 /PRNewswire/ -- Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis. Zabalafin Hydrogel is unique in its ability to directly treat all the problems of AD, specifically directly treating the bacterial cause of AD, directly treating AD's pruritus (itch), and directly treating the immuno-inflammatory cause of the disease.

Maryland-founded healthcare company continues to lead in medical diagnostic innovation

COLUMBIA, Md., (February 18, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 dual investment in Novel Microdevices, a company aiming to provide quality point-of-care diagnostics. This investment included $250,000 from the Venture Funds and $250,000 from the Inclusion Fund, a fund under the Social Impact Funds umbrella.

“Our company has made incredible progress during the past year since TEDCO chose to invest in our vision,” said Andrea Pais, CEO of Novel Microdevices “This investment will play an important role in ensuring our product, NovelDx, makes an impact in the healthcare industry.”

Novel Microdevices, located in Baltimore, Md., is a medical device company developing a solution for clinical diagnostics. Through research and development efforts, the company founded the NovelDx device – a solution that seeks to challenge the point-of-care antigen and molecular testing market by providing lab-level PCR tests in under 15 minutes.

The Deloitte AI Institute has launched a new video series, You, Me, and Three: GenAI Questions, featuring industry leaders discussing the rapid transformation of federal health through generative AI and automation. BHI Board of Directors Member Juergen Klenk, Principal at Deloitte Consulting LLP, joined Beena Ammanath in this series to explore how organizations can cut through the AI hype and establish trust around AI. Watch the full series to gain insights from cross-industry experts on the future of AI in healthcare.

https://youtu.be/dNFsBSjBCFc

GAITHERSBURG, Md.--(BUSINESS WIRE)--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced ultraRapid Whole Genome Sequencing, offering accelerated and comprehensive genomic insights for neonatal and pediatric patients in the NICU and PICU in as soon as 2 days.