WASHINGTON, March 31, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti™.

U.S. tariffs on imports could increase the cost of biotechnology operations, threatening innovation that helps patients, according to a survey of biotech firms by the Biotechnology Innovation Organization (BIO).

Nearly 90% of U.S. biotech companies rely on imported components for at least half of their Food and Drug Administration (FDA)-approved products, and they say tariffs would hurt their business, the survey of BIO member companies found.

“This survey demonstrates the far-reaching and potentially damaging impacts of the proposed tariffs on our biotechnology industry, on biomedical research and on patients,” said BIO President & CEO John F. Crowley.

BETHESDA, Md., March 31, 2025 (GLOBE NEWSWIRE) -- CorVista Health today announced a poster presentation showcasing preliminary results of its machine learning-based algorithm for non-invasively estimating pulmonary capillary wedge pressure (PCWP) elevation – a key indicator of heart failure with preserved ejection fraction. The poster titled ‘Point-of-Care Testing for Pulmonary Capillary Wedge Pressure Elevation Using Machine Learning on Non-invasive Signals’ was presented at the American College of Cardiology’s Annual Scientific Session (ACC.25) in Chicago on March 30, 2025.

Currently, PCWP is measured through an invasive right heart catheterization (iRHC) procedure that requires a cardiologist, pulmonologist or intensivist. The CorVista capture device collects non-invasive signals for 3.5 minutes in patients at rest, which could potentially provide an alternative to iRHC in certain patient populations. The data demonstrate how machine learning signal analysis of a symptomatic population may provide a robust, non-invasive alternative to measuring PCWP elevation, potentially making early detection of HFpEF and PH subtypes more accessible.

Bethesda, MD — March 28, 2025 – Solaxa Inc., a biopharmaceutical public benefit corporation focused on rare neurological conditions, has announced plans to conduct a registrational clinical trial evaluating its investigational therapy, SLX-100, for spinocerebellar ataxia type 27B (SCA27B).

This pivotal-powered study will be funded in part by a $7.3 million dollar grant awarded to Dr. Susan Perlman, MD, at the University of California, Los Angeles by the Congressionally Directed Medical Research Program. Solaxa will serve as the regulatory sponsor of the trial and partner with leading ataxia centers of excellence. Additional clinical trial sites will be announced later this year.

There are currently no FDA approved therapies for SCA27B, a rare hereditary ataxia. “We are thrilled to move one step closer to impacting the lives of people living with SCA27B,” said Christian Walker, CEO & Founder of Solaxa.

Emily Seymour | InsideNoVa Mar 28, 2025 - George Mason University held the grand opening of its new life sciences and engineering building in Manassas on Thursday, celebrating the addition to its Science and Technology Campus.

The $107 million project supports the university’s growing need for specialized instructional labs, classrooms and support spaces for students, officials said. The building has classrooms and more than 30 different lab spaces for teaching, design and fabrication, offering hands-on learning for students across a number of disciplines.

University leaders celebrated the opening Thursday, joined by local leaders, including Virginia Del. Luke Torian, Del. Ian Lovejoy, Del. Briana Sewell, state Sen. Danica Roem and several members of the Prince William Board of County Supervisors.

By Dan Beyers, Katelyn Keiser - CoStar News - March 26, 2025 - If there is a field of dreams in Baltimore these days, it might be 4MLK, the gleaming new eight-story, 250,000-square-foot lab and office building that stands at the gateway of the University of Maryland's life science and technology center, BioPark.

When it is fully leased, 4MLK hopes to house the largest cluster of bioscience companies in the greater Baltimore region, bringing 1,000 jobs to the city and doubling the size of the workforce now employed by nearly three dozen companies at the center. It's an ambition that earned the project a 2025 CoStar Impact Award as judged by real estate professionals in the market.

COLLEGE PARK, Md., March 26, 2025 /PRNewswire/ -- Registration is open for "Business of Life Sciences and Healthcare for Leaders" (B-LSHC) — an immersive five-day program focused on leadership development and honing critical-thinking and problem-solving skills in medical product development presented by Smith Executive Education at the University of Maryland's Robert H. Smith School of Business.

The in-person program takes place June 23-27, 2025, at Van Munching Hall on UMD's College Park campus and is designed for mid-to-advanced career professionals in the LSHC ecosystem including pharmaceutical, biotech and medical device industries; health policy; patient advocacy; regulators; investors; and leaders across medical and regulatory fields.

Program sessions will begin at 8:30 a.m. each day "and end with a luminary keynote speaker who will inspire and challenge participants to think outside the box toward the goals of creating innovative solutions for some of our most challenging problems in the LSHC ecosystem," says Wendy Sanhai, PhD, professor of the practice in management and organization for the Smith School and one of the workshop's organizers. 

March 25, 2025 - John Knowles, Studio B Writer - The BioCapital Region, which includes Washington, D.C., Maryland and Virginia, is one of the top life sciences clusters in the United States.

Prince William County has rapidly emerged as a key player in Northern Virginia’s life sciences sector. The Prince William County Department of Economic Development and Tourism, or PWCDEDT, has been focused on diversifying the economy and leveraging assets like George Mason University’s Science and Technology Campus to attract innovative companies to the region.

PWCDEDT Deputy Director Trevor Johnson said that the county’s life sciences growth can be traced back to its abundant rural land, offering a rare opportunity for expansion in the Greater Washington area.

PLANO, Texas & BALTIMORE--(BUSINESS WIRE)--Secretome Therapeutics, a clinical-stage biotechnology company developing novel therapies derived from neonatal cardiac progenitor cells (nCPC), today announced dosing of the first patient in its Phase 1 clinical trial evaluating STM-01 as a treatment for heart failure with preserved ejection fraction (HFpEF).

This is the first-ever clinical study of an allogeneic, off-the-shelf stem cell therapy in HFpEF, a leading cause of hospitalization, morbidity, and mortality worldwide. An estimated 6.7 million adults in the U.S. are affected by heart failure, with HFpEF comprising at least half of these cases.

NanoQT, a Tokyo-based quantum computing company, recently announced its expansion into Maryland, with the intent to strengthen the company’s research and development capabilities and commercialization in the U.S.

The move follows the company’s participation in Maryland’s Global Gateway program, which incentivizes foreign companies to “soft land” in the U.S., offering affordable office spaces at Maryland incubators as well as access to advisors and other resources. As a Global Gateway participant, NanoQT took up residency at the Quantum Startup Foundry incubator on the University of Maryland campus, where the company will maintain its presence.

Technology development company will invest $200,000 and create 20 new jobs 

RICHMOND, VA — Governor Glenn Youngkin today announced that Luna Labs USA, LLC, a product development company accelerating breakthrough solutions to multiple industries, will invest $200,000 to expand its operations in the City of Charlottesville. The company will create 20 new jobs.  

“Luna Labs' expansion demonstrates Virginia's ability to cultivate and retain innovative technology companies,” said Governor Glenn Youngkin. “When high-tech firms choose to grow in the Commonwealth, it reinforces our position as a hub for research and development, particularly in sectors like aerospace, energy and defense. LunaLabs' success story showcases how Virginia's world-class talent pipeline and collaborative ecosystem help companies thrive.” 

Digital Health Leader's Innovation in Real-Time Sensor-Based AI Sets New Standards for Personalized Cardiometabolic Care

COLUMBIA, Md.--(BUSINESS WIRE)--Welldoc®, a digital health leader revolutionizing cardiometabolic care, today announced the issuance of four new patents, marking its 54th patent grant. This milestone underscores Welldoc’s relentless commitment to innovation and leadership in leveraging artificial intelligence (AI) and advanced predictive capabilities based on real-time sensor data. The company’s digital health platform empowers individuals with personalized AI-driven digital coaching to enable self-management of cardiometabolic conditions, positive lifestyle changes and improved overall health and outcomes.

The new patents focus on Welldoc's unique approach to combining dense, sensor-based data specifically collected from Continuous Glucose Monitors (CGM), with AI to predict future engagement levels, health metrics and improved outcomes. This includes the development of a "CGM-GPT" model using generative AI techniques to predict future glucose values.

Biosensor company receives additional funding to continue development and research

COLUMBIA, Md., (March 19, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Venture Funds investment in Hememics Biotechnologies, Inc. TEDCO’s evergreen Venture Funds are dedicated to funding and growing the next generation of early-stage businesses in Maryland.

“I am excited to be a part of Hememics’ mission to transform the future of diagnostics,” said John Warden, CEO of Hememics Biotechnologies, Inc. “Thanks to TEDCO’s latest investment, we are looking forward to continuing our growth and development. If you’re an entrepreneur in Maryland looking to flourish, I highly recommend connecting with TEDCO; there are several resources and opportunities the organization can offer – it’s so much more than just funding.”

BALTIMORE--(BUSINESS WIRE)--Sapio Sciences, the science-aware™ lab informatics platform, today announced the integration of the NVIDIA BioNeMo platform into the Sapio Lab Informatics Platform. This integration brings AI-driven computational drug discovery directly into Sapio ELN (Electronic Lab Notebook), helping to streamline workflows and improve decision-making in drug discovery.

With the BioNeMo platform, researchers can accelerate drug discovery by leveraging science-specific AI frameworks, pre-trained models, and generative AI tools to streamline the identification of potential drug candidates and improve target selection accuracy. NVIDIA BioNeMo provides scientists with a framework for training and deploying large biomolecular language models at supercomputing scale.

GeneDx recognized for its innovative approach to accelerating genetic diagnosis and transforming the future of healthcare by ending the diagnostic odyssey

GAITHERSBURG, Md.--(BUSINESS WIRE)--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, announced today they have been named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025, and recognized as the No. 2 in the Biotech category. This year’s list shines a spotlight on businesses that are shaping industry and culture through their innovations to set new standards and achieve remarkable milestones in all sectors of the economy.

Validation Completed for a Novel, Cost-Competitive Epinephrine Active Pharmaceutical Ingredient Process, Drug Master File Successfully Filed

Richmond, Virginia, March 17, 2025 (GLOBE NEWSWIRE) -- Phlow Corp., a U.S.-based certified B Corporation on a mission to bring medicines to life through advanced development and manufacturing in America, today announced a major milestone, achieving a successful process validation campaign for Epinephrine active pharmaceutical ingredient (API) production. This achievement positions Phlow to continue advancing toward full domestic production capabilities in its state-of-the-art U.S. facilities for this life-saving medicine.

The British drugmaker is paying up to $1 billion to buy the Belgian startup, whose technology it sees as useful in treating cancer as well as autoimmune conditions.

AstraZeneca is bolstering its cell therapy capabilities, agreeing on Monday to pay up to $1 billion for a biotechnology startup making treatments that reprogram cells inside the body.

The British drugmaker is buying EsoBiotech, a Belgian startup, for $425 million in cash upfront. EsoBiotech’s investors, among them Invivo Partners and UCB Ventures, could receive up to $575 million in additional payouts should the startup’s programs hit certain development and regulatory milestones, AstraZeneca said in a statement.

The National Institutes of Health (NIH) is vital in driving scientific discovery and economic growth across the United States. Recent reports from United for Medical Research (UMR) and Forbes highlight just how impactful NIH funding has been—generating $94.58 billion in economic activity in FY2024 alone and supporting more than 407,000 jobs nationwide. For every $1 invested, NIH research funding returns $2.56 in economic impact.

For the BioHealth Capital Region (BHCR)—home to NIH, the FDA, and a growing network of research institutions and life sciences companies—this funding is critical. NIH grants fuel the work of startups, researchers, and small businesses developing groundbreaking technologies in biotech, AI-driven drug discovery, personalized medicine, and advanced therapeutics. Without sustained investment, the entire innovation ecosystem is at risk, impacting job creation, commercialization efforts, and, ultimately, patient outcomes.

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.