BETHESDA, Md., May 06, 2024 (GLOBE NEWSWIRE) -- AsclepiX Therapeutics, Inc., a clinical-stage biopharmaceutical company leveraging computational biology from Johns Hopkins to identify and develop peptides for improved treatments of retinal diseases, today announced the completion of enrollment into the DISCOVER trial (NCT05859776). Fifteen patients have completed enrollment in the trial for AXT107 (gersizangitide). The objectives of the trial are to evaluate the safety and tolerability of three dose strengths of AXT107 [125 µg (n=3), 250 µg (n=3), and 500 µg (n=9)] and to determine the bioactivity and duration of action when injected suprachoroidally. Secondary endpoints will include efficacy as assessed by central subfield thickness (CST) and best-corrected visual acuity (BCVA). Following a single injection of AXT107, to date, no patient has shown any remarkable safety findings.

ROCKVILLE, Md.--(BUSINESS WIRE)--GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today announced topline results from its Phase 3 global pivotal study of uproleselan in 388 patients with R/R AML. In the study, uproleselan combined with chemotherapy did not achieve a statistically significant improvement in overall survival in the intent to treat population versus chemotherapy alone.

May 2, 2024, Emily Wishingrad, Washington, D.C.
Maryland’s life sciences market, one of the largest in the country, has a lot of things going for it — a hearty talent pipeline, federal research agencies and relatively cheap real estate prices.

One thing that it doesn’t have pinned down quite yet: the urban, mixed-use, flexible developments that are most attractive to today's tenants.
Local leaders and industry executives at Bisnow’s Mid-Atlantic Life Sciences and Biotech Summit last week said that for the area to keep up with its peer markets like Boston-Cambridge and San Diego, developers need to start thinking outside the traditional life sciences box.

Frederick, MD, May 2, 2024 – BioSolution Designs (BSD), a biotechnology invention studio developing proprietary platforms for multigenic gene and cell therapies, today announced its ongoing strategic collaboration with RoosterBio, a leading provider of human mesenchymal stem/stromal cells (MSCs), highly engineered media solutions, and bioprocess development services.

This partnership leverages BSD’s multigenic design and assembly platform, Bird of Prey^™, and cell engineering expertise along with RoosterBio’s cutting-edge MSC and exosome bioprocessing products, manufacturing protocols, and analytical services to simplify the development and manufacturing of engineered MSC derived therapies.

The ARPA-H Sprint for Women’s Health is a funding opportunity to address critical unmet challenges in women’s health, championing transformative innovations and tackling health conditions that uniquely or disproportionately affect women. ARPA-H is committing $100 million to this effort and is using two funding tracks, spark (early-stage research) and launchpad (later-stage development), to foster transformative research and development efforts. 

ARPA-H had an unprecedented response of submissions, representing 45 states, the District of Columbia, and 34 countries, received from a mix of scientific visionaries from across the globe and sectors. More than half of those submissions came from organizations with less than 50 people. Proposals covered the six topics, including the wild card, and innovative ideas ranged from novel, groundbreaking research to opportunities to accelerate and scale tools, products, and platforms with potential for commercialization. 

FREDERICK, MD, UNITED STATES, May 1, 2024 /EINPresswire.com/ -- BioSolution Designs is pleased to announce the formation of its first drug development subsidiary, BeatBio, created to develop complex multigenic therapeutics for cardiovascular diseases.

The company, headquartered in Cincinnati, is led by Thomas D Reed, PhD, who previously co-developed a multigenic plasmid DNA (pDNA) gene therapy (INXN-4001) at Triple-Gene, a cardiovascular gene therapy subsidiary of Intrexon (now Precigen – PGEN), which showed a functional improvement in 50 percent of heart failure patients after a single dose in early human testing.

BeatBio will deploy BioSolution Designs’ proprietary Bird of PreyTM multigenic design and assembly system to develop complex therapies to treat cardiovascular and peripheral artery disease. The highly-engineered yet easy-to-use platform enables faster and cheaper design and assembly of a “library” of complex vectors, for screening multiple genetic combinations to prioritize the best therapeutic candidates.

Eligible small businesses may receive millions of non-dilutive dollars from NIH’s Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) programs. Funding comes in tranches, from $300,000 – $4 million, based upon the stage of development and likelihood of the end product “moving the needle” in healthcare.

With over $1.3B dollars each year to fund U.S. startups, the National Institutes of Health (NIH) Small Business portfolio consists of life science companies dedicated to developing a full range of advanced technologies and products to improve the human condition.

Eligible small businesses may receive multiple millions of non-dilutive dollars from NIH’s Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) programs. Funding comes in tranches, from $300,000 – $4 million, based upon the stage of development and likelihood of the end product “moving the needle” in healthcare. Only the most innovative projects, with reasonable research plans, a strong team, and access to commercialization resources are funded. NIH-funded companies are often leading the curve in solving the most intractable healthcare challenges.

Acquisition will strengthen Deloitte team with a complement of data-driven biosecurity detection, prevention and emergency response solutions

ARLINGTON, Va., April 29, 2024  /PRNewswire/ -- Deloitte announced that it has acquired substantially all of the assets of Gryphon Scientific, LLC (Gryphon), a leader in biosafety, biosecurity, and all-hazards preparedness and response, with experience in using artificial intelligence (AI) to enhance security and safety. Deloitte's competitive edge will be strengthened by Gryphon's multidisciplinary team who will be joining Deloitte, comprising scientists, programmers, and policy and planning professionals with experience in data science, scientific communications, modeling and risk assessment. Gryphon's cadre of specialists will enhance Deloitte's capability to address its clients' most complex mission challenges, from informing safe policy and practice around novel technologies and AI to strengthening capacities to prevent, detect and respond to infectious disease threats across the globe.

Venlo, the Netherlands, April 29, 2024 (GLOBE NEWSWIRE) -- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced results for the first quarter of 2024.

Net sales declined 5% to $459 million, while results at constant exchanges rates (CER) of $462 million were above the outlook for at least $455 million CER. The adjusted operating income margin rose to 25.7% from 25.6% in the year-ago period on realized efficiency gains while supporting investments into the portfolio. Adjusted diluted earnings per share (EPS) were $0.46, and results at CER were $0.47 and above the outlook for at least $0.44 CER.

For 2024, QIAGEN has reaffirmed its outlook for net sales of at least $2.0 billion CER. Adjusted diluted EPS are expected to be at least $2.10 CER, led by the adjusted operating income margin rising to above 28% of sales for FY 2024 compared to 26.9% in 2023 while supporting investments.

AURP awarded $50,000 in prize money for equitable access to entrepreneurship

WASHINGTON, DC, and TUCSON, AZ / ACCESSWIRE / April 24, 2024 / The U.S. Small Business Administration (SBA) this week announced the Association of University Research Parks (AURP) as a Stage One winner for the 2024 Growth Accelerator Fund Competition (GAFC). AURP will receive a $50,000 cash prize for its impactful and inclusive approach to nurturing a collaborative national innovation ecosystem to advance small business research and development (R&D) from ideas to the market.

By fostering connections between entrepreneurs, mentors, partners, philanthropies, corporations, investors and other shared resources, GAFC 2024 catalyzes strategic ecosystem partnerships to build community and organizational capacity for the successful launch, growth and scale of STEM (Science, Technology, Engineering, and Mathematics)-based entrepreneurs.

BETHESDA, Md., April 24, 2024 (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, announces positive results from the single ascending dose (SAD) part of its Phase 1 study. GT-02287 was generally well tolerated up to and including the highest planned dose level, and there were no serious adverse events. The good safety and tolerability profile and the appropriate range of plasma exposure levels achieved after oral administration further bolster GT-02287’s best and first-in-class potential.

The first living recipient of a UThymoKidney, in conjunction with a heart pump implant, is recovering after a successful transplant

This transplant builds on two successful UHeart transplants completed in 2022 and 2023

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced the world’s first successful transplant of a UThymoKidney™, which the company produced, into a living person on April 12, 2024. This transplant represents several historic firsts for transplantation:
- The first-ever transplant of a xenothymokidney into a living human recipient;
- The first-ever combined mechanical heart pump and organ transplant; and
- The first-ever xenotransplant into a living human using only FDA-approved immunosuppressive medicines

The transplant is the third xenotransplant using United Therapeutics’ xeno organs, following two successful UHeart™ transplants at the University of Maryland Medicine in 2022 and 2023.

Benevento to lead Virginia’s strategic authority that invests in startup companies, entrepreneurship ecosystems, university commercialization, innovation growth

VIPC is well-positioned to lead Virginia in developing, attracting, and retaining talent, capital, and innovation which expands investment, growth, and opportunity across the entire Commonwealth.”— Joe Benevento, VIPC President and CEO
RICHMOND, VIRGINIA, UNITED STATES, April 24, 2024 /EINPresswire.com/ -- The Board of Directors of the Virginia Innovation Partnership Corporation (VIPC) has announced that it has unanimously selected Joe Benevento as President and CEO of VIPC.

Benevento has led VIPC as Interim President and CEO since September 2023 and previously served as Deputy Secretary of Commerce and Trade for the Commonwealth of Virginia since 2022. As Virginia’s Deputy Secretary of Commerce, Benevento helped develop Virginia’s “Compete to Win” and “Innovative Framework” strategy for driving economic growth across all regions of the Commonwealth and oversaw an industry portfolio which included Technology, Life Sciences, Aerospace & Defense, Semiconductors, Advanced Manufacturing, Cybersecurity, Unmanned Systems, and other key sectors.

April 23, 2024, Patrick Sisson, Bisnow National - One of the life sciences real estate’s biggest players sees a clear road to recovery, predicting that momentum, in the form of the increased investment dollars seen in early 2024, will hit its stride as the current glut of new supply tapers off in 2025.

During Alexandria Real Estate Equities’ first quarter earnings call, Chairman Joel Marcus cited “positive signs of rebound” in investment and financing for biotech, as well as strong performance from the REIT, which saw total revenues grow 9.7% to $769M.

Investments in the sector showed strength not seen since the high point of 2021. Nearly $11B in venture capital deployment in biotech was announced in Q1 2024, according to a sector overview from Alexandria Senior Vice President of Science and Technology Hallie Kuhn, who said increased investment was a “robust sign of the health of the industry.”

CHARLOTTESVILLE, VA – April 22, 2024 – AMPEL BioSolutions has been selected as a member - or "spoke" - of the Customer Experience Hub of ARPANET-H, a prestigious nationwide health innovation network launched by the Advanced Research Projects Agency for Health (ARPA-H).  This national effort is designed to accelerate commercialization of health breakthroughs for populations that urgently need them.  

The Customer Experience Hub in Dallas joins Boston and the Nation's Capital as the three hubs across the country tasked with creating better health outcomes for all by accelerating commercialization of groundbreaking technologies that focus on health in two ways, by optimizing clinical trials for disease-altering therapies and implementing technologies that monitor & predict health outcomes.  This "prevent-detect-treat" effort connects biotechnology companies with funders, universities and non-profits in order to scale health breakthroughs.  

Rockville, MD, April 22, 2024 – U.S. Pharmacopeia (USP) is honored to announce its selection as a member of the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), an organization that brings together biopharmaceutical industry partners across the manufacturing supply chain to support the Biomedical Advanced Research and Development Authority (BARDA).

The BioMaP-Consortium serves a critical role in ensuring that the United States can respond rapidly to public health emergencies by convening public and private industry partners to expand capacity and capabilities to produce medical countermeasures, products that help diagnose, prevent, or treat diseases related to chemical, biological, radiological, or nuclear threats.

Shenzhen Salubris commits additional funding to continue research and development of novel, complex biologics

First patient enrolled in RENEU-HF, the Phase 2 clinical trial of JK07 in heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF)

Clinical trial application filed for JK06, SalubrisBio’s first-in-class biparatopic ADC

April 22, 2024 07:00 AM Eastern Daylight Time
GAITHERSBURG, Md.--(BUSINESS WIRE)--Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced a new capital infusion of $35 million to fund continued research and development of clinical and pre-clinical programs. SalubrisBio also provided progress updates for JK07, the first investigational antibody fusion protein for heart failure, JK08, the first investigational IL15-CTLA4 antibody fusion for solid tumors and JK06, a first-in-class biparatopic antibody-drug conjugate (ADC) targeting a known tumor antigen.

Pioneering Move Unites Medical and Pharmacy Benefits, Enhancing Access, Affordability, and Adherence for Specialty Medications and Procedures

ROCKVILLE, Md., April 18, 2024 /PRNewswire/ -- Healthcare technology pioneer DrFirst today announced it has acquired substantially all assets of Myndshft Technologies, Inc., a leader of end-to-end real-time medical benefits and automated prior authorization (PA) software-as-a-service (SaaS). This strategic acquisition aims to improve the patient experience and expedite access to vital specialty medications, such as infusions and in-office injectables primarily covered by medical benefits. Combined with DrFirst's platform and scale, the technology will also lighten the substantial administrative load on healthcare providers and their staff.

Founded in 2018, Myndshft is the only unified platform that streamlines prior authorization and related services for both medical and pharmacy benefits. This innovative technology uses AI, machine learning, and robotic process automation (RPA) to automate and streamline complex benefits, pricing, and PA processes across various payers and therapeutic classes into one seamless, intuitive workflow. The Myndshft platform also supports labs, imaging, and other procedures covered under medical benefits, which are often prerequisites for patients prescribed specialty medications.

April 18, 2024
For Global Investor Audience Only

Novavax’s Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) is now available to pharmacies across the United Kingdom (U.K.) for private healthcare providers to offer an updated protein-based non-mRNA option as part of the 2024 vaccination season.

Today is an important milestone for our organization. It demonstrates our commitment to deliver an updated protein-based COVID-19 vaccine as we evolve into an endemic market. It also underscores our place as a long-term partner to public health. We believe a diverse vaccine portfolio and broader access can play vital roles in protecting communities in the U.K. and elsewhere.

Multi-institute clinical trial demonstrates therapy can be safely used in pediatric regional centers

WASHINGTON, April 18, 2024 (GLOBE NEWSWIRE) -- In a first-of-its-kind clinical trial, researchers found that intravenous therapies made from virus-specific T-cells (VST) can effectively treat immunocompromised pediatric patients, far surpassing the current standard of care, according to new research published in Nature Communications.

More than 60% of patients in the phase 2 clinical trial led by investigators from Children’s National Hospital and Huntsman Cancer Institute responded to the innovative VST therapy. This new treatment uses blood from healthy donors to manufacture a highly specialized immune therapy that, when given to immune-compromised patients, prompts their immune system to fight off potentially life-threatening viruses, including cytomegalovirus, Epstein-Barr and adenovirus. Without this therapy, estimates suggest that less than 30% of patients would recover, using standard protocols.

OXFORD, United Kingdom, April 18, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer, today announced topline final data from the APOLLO trial (also known as HPV001), a completed randomized, placebo-controlled Phase 1b/2 dose-ranging trial of VTP-200 in women with low-grade cervical lesions associated with persistent hrHPV infection.

“This was our first in-human, dose-ranging trial of VTP-200 in women with hrHPV-associated low-grade cervical lesions, who currently don’t have any treatment option until progression to high-grade lesions,” said Bill Enright, Chief Executive Officer of Barinthus Bio. “While we didn’t observe a significant improvement from VTP-200 in the overall pooled results, we did observe positive trends in the highest dose cohorts.”

PitchBook’s VC Ecosystem Rankings compare global cities based on the size and maturity of their startup networks. The framework helps founders, operators and investors assess locations when deciding where to expand or invest.

Network effects matter in venture capital: Investors get more than half of their deals through referrals, according to research led by Harvard professor Paul Gompers. So it stands to reason that dealmakers should seek these networks out when deciding where to do business.

The list is based on a scoring system that uses PitchBook’s proprietary data on private companies. Development and growth scores are based on data related to deals, exits fundraising and other factors from the last six years.

Washington, DC (April 17, 2024) – Venable LLP is pleased to announce that it has been named to American Lawyer magazine’s 2024 Am Law 100 list. The annual ranking lists U.S. law firms based on 2023 gross revenue. Venable LLP moved up the list from last year to #64.

The firm also ranked strong in other categories, including:

• #62 – Revenue per Lawyer
• #67 – Profits by Lawyer
• #78 – Compensation – All Partners
• #80 – Profits per Equity Partner

BY ERIC SCHMIDTAPRIL 16, 2024 4:20 PM EDT
Schmidt, Commissioner, National Security Commission on Emerging Biotechnology; Co-founder with his wife Wendy, Schmidt Sciences; Former CEO & Chairman, Google

Imagine a world where everything from plastics to concrete is produced from biomass. Personalized cell and gene therapies prevent pandemics and treat previously incurable genetic diseases. Meat is lab-grown; enhanced nutrient grains are climate-resistant. This is what the future could look like in the years ahead.

The next big game-changing revolution is in biology. It will allow us to more effectively fight disease, feed the planet, generate energy, and capture carbon. Already we’re on the cusp of these opportunities. Last year saw some important milestones: the U.S. approved the production and sale of lab-grown meat for the first time; Google DeepMind’s AI predicted structures of over 2 million new materials, which can potentially be used for chips and batteries; Casgevy became the first approved commercial gene-editing treatment using CRISPR. If I were a young person today, biology would truly be one of the most fascinating things to study.

Joel Marcus, the longtime head of Alexandria Real Estate Equities, sees few near-term challengers to the established biotech hubs of Boston, San Diego and San Francisco.

Joel Marcus built a real estate empire on the life sciences industry’s steady growth. Over three decades, his company Alexandria Real Estate Equities has amassed tens of millions of square feet of office and laboratory space in drug development hubs like Boston, San Diego and the San Francisco Bay Area.

Those holdings have given Alexandria a front row seat to biotech’s boom over much of the past decade through to the sector’s pandemic highs and more recent downturn.

2024 may well become the year of the bootstrapped founder.

The startup “mass extinction event” that doomsayers have predicted for two years is likely to ramp up in 2024. New founders facing a brutal funding environment may instead opt to bootstrap their growth.

Over 55,000 VC-backed companies are operating in the US right now, according to the latest PitchBook-NVCA Venture Monitor. Many of them are aggressively competing for funding in a slow dealmaking landscape.

At the same time, over 2,000 VC firms effectively halted making new investments in startups in the first nine months of 2023. Approximately 3,200 startups failed in 2023, and there’s even a burgeoning industry dedicated to helping founders wind down their companies.

Read more ...

Maryland biotech company continuing mission to provide antibiotic sensitivity precision diagnostics

COLUMBIA, Md. (April 15, 2024) – fdfsTEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Seed Funds investment in Astek Diagnostics, a biomedical company.

“From the early days in my basement during the pandemic, TEDCO saw potential in our idea and supported us with our very first check,” said Mustafa Al-Adhami, CEO of Astek Diagnostics. “Today, our team stands strong at nine, having achieved the milestone of our first version of the product and partnerships with urology practices and hospitals across the globe.”

[4/15/2024] Today, FDA's Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally.

“CDER’s long-standing efforts to embed innovation in clinical trial design and conduct into our regulatory work have been crucial in bringing new therapies to areas of unmet medical need,” said Patrizia Cavazzoni, M.D., director of CDER. “We are eager to build on this foundation by launching C3TI to further spur the adoption of clinical trial innovation across industry and within CDER.”

Senators Cardin and Van Hollen requested more than $1 million to fund this new program

COLUMBIA, Md., (April 11, 2024) — TEDCO, Maryland’s economic engine for technology companies, has received $1,150,000 in Congressionally Directed Spending to advance its Federal Lab Leveraging Innovation to Products (FLLIP) Pilot Program. The direct spending request was sponsored by U.S. Senators Ben Cardin and Chris Van Hollen (D-Md.) and included in the Fiscal Year 2024 Financial Services and General Government funding bill, which was signed into law last month as part of a FY24 appropriations package.

“Maryland is home to more than 70 federal labs, from the NIH in Silver Spring to the Frederick National Lab for Cancer Research and the Army Medical Research and Development Command,” said Senator Cardin. “With this federal investment, we’re making it easier for traditionally underserved businesses in the healthcare industry to take full advantage of the resources right in their backyard. Community partnerships like the FLLIP Program drive innovation in the state and help build a more equitable, prepared and developed health care system.”

By Rebekka Spiller - For inventor and CEO Sue Carr, tenacity and determination drive success. The founder of CarrTech Corp. says that challenges helped her envision a revolutionary innovation in health care: the FROG ® needle.

FROG ® stands for Filter Removal of Glass and is the only all-in-one needle designed to filter out glass shards from ampoules prior to administering medication to patients. It offers three main purposes: to ensure that practitioners do not bypass the filtering process, to reduce needle prick injuries and to save time in emergency situations.

Carr’s journey was initiated after deciding to transition from her longtime role as hometown pharmacist to clinical pharmacist for hospitals. After spending time working alongside various doctors and nurses, she noticed a concerning trend.

SAN DIEGO — Kimryn Rathmell, director of the National Cancer Institute, gestured toward the screen and asked an audience of clinicians, researchers, and patient advocates what they thought they were looking at. Projected behind her was a patchwork of purple, red, pink, and blue squares.

Moments later, a larger-than-life image of Taylor Swift flashed in the middle of the pattern, and laughter rippled through the room here at the American Association for Cancer Research annual meeting as attendees realized they were staring at a poster of the singer’s “Eras Tour.”

COLUMBIA, Md. (April 8, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $100,000 Pre-Seed Builder Fund investment in Aloe Therapeutics, a company working to deliver cancer cures. TEDCO’s Pre-Seed Builder Fund is housed under TEDCO’s Social Impact Funds which were created to engage and invest in economically underserved founders and communities.

“At Aloe Therapeutics, we are working to increase efficacy and expand eligibility for patients with hard-to-treat solid tumors and limited treatment options,” said Martha Sklavos, founder and CEO of Aloe Therapeutics. “Thanks to TEDCO’s investment we can continue to develop our lead therapy to the clinic to ‘wake up the immune system’ with our cell-based therapeutic vaccine, Allo-Immunotherapy (AIM).

GAITHERSBURG, Md. – Adventist HealthCare has been named one of Newsweek’s Most Trustworthy Companies in America 2024. The list of 700 U.S. companies was announced March 27 after an analysis by Newsweek and Statista Inc., the world-leading statistics portal and industry ranking provider.

Adventist HealthCare was among only 10 hospitals and healthcare systems in the U.S. to receive this prestigious recognition.

Adventist HealthCare ranked 18th among 37 public and private organizations in the Healthcare and Life Sciences category, which included a broad range of care providers, device manufacturers, pharmaceutical companies, and online health and wellness firms.

BETHESDA, Md.--(BUSINESS WIRE)--The Cystic Fibrosis Foundation is investing up to $8.5 million in additional funds in SpliSense to continue clinical trials for its inhaled antisense oligonucleotide (ASO) drug for people with cystic fibrosis who have certain splicing mutations and potentially other rare mutations.